TExTMED+FANSII: TExT-MED + FANS Full Trial

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT03178773
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.5
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Behavioral: TExT-MED; Behavioral: FANS	Phase 2

Detailed Description

Diabetes has disproportionately affected the Latino population. TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes. Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter. mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place. The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS. This is a 12 month, randomized study of this intervention. At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Trial to EXamine Text Messaging for Diabetes in ED Patients Incorporating Social Support - Intervention With Washout
• Actual Study Start Date: Jul 18, 2017
• Actual Primary Completion Date: Dec 2, 2019
• Actual Study Completion Date: Dec 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TExT-MED only Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.	Behavioral: TExT-MED; messages designed to inspire motivation and behavior change
Experimental: TExT-MED+FANS Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.	Behavioral: TExT-MED; messages designed to inspire motivation and behavior change; Behavioral: FANS; SMS delivered messages to family members to improve social support

Outcome Measures

Primary Outcome Measures

1. Change in HBA1c From Baseline [6 Months]

   Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.

Secondary Outcome Measures

1. Change in HBA1c From 6 Months to 12 Months [12 months]

   Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value.

2. Change in BMI From Baseline [6 Months]

   Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

3. Change in BMI From 6 Months to 12 Months [12 Months]

   Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.

4. Change in Abdominal Circumference From Baseline [6 Months]

   A measure of central adiposity, it correlates with cardiovascular outcomes.

5. Change From Abdominal Circumference From 6 Months to 12 Months [12 Months]

   A measure of central adiposity, it correlates with cardiovascular outcomes.

6. Change in Systolic Blood Pressure From Baseline [6 Months]

   Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

7. Change in Systolic Blood Pressure From 6 Months to 12 Months [12 Months]

   Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications

8. Change in Diastolic Blood Pressure From Baseline [6 Months]

   Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

9. Change in Diastolic Blood Pressure From 6 Months to 12 Months [12 Months]

   Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.

10. Change in Summary of Diabetes Self-care Activities From Baseline [6 Months]

    Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

11. Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months [12 Months]

    Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.

12. Change in Wilson 3 Item Scale From Baseline [6 Months]

    Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.

13. Change in Wilson 3 Item Scale From 6 Months to 12 Months [12 Months]

    Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.

14. Change in Healthcare Utilization From Baseline [6 Months]

    Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

15. Change in Healthcare Utilization From 6 Months to 12 Months [12 Months]

    Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.

16. Change in Diabetes Empowerment Scale Short Form From Baseline [6 Months]

    Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.

17. Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months [12 months]

    Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.

18. Change in Diabetes Distress Scale From Baseline [6 Months]

    Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress

19. Change in Diabetes Distress Scale From 6 Months to 12 Months [12 Months]

    Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress

20. Change in Patient Health Questionnaire 9 From Baseline [6 Months]

    Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.

21. Change in Patient Health Questionnaire 9 From 6 Months to 12 Months [12 Months]

    Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.

22. Change in Fatalism From Baseline [6 Months]

    Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.

23. Change in Fatalism From 6 Months to 12 Months [12 Months]

    Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.

24. Change in WHO Quality of Life From Baseline [6 Months]

    Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.

25. Change in WHO Quality of Life From 6 Months to 12 Months [12 Months]

    Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.

26. Change in Diabetes Family Behavior Checklist - Supportive From Baseline [6 Months]

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

27. Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months [12 Months]

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

28. Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline [6 Months]

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

29. Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months [12 Months]

    Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.

30. Change in Diabetes Care Profile Support From Baseline [6 Months]

    Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.

31. Change in Diabetes Care Profile Support From 6 Months to 12 Months [12 Months]

    Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.

32. Change in Norbeck Social Support Questionnaire From Baseline [6 Months]

    Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)

33. Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months [12 Months]

    Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)

34. Change in Partner Distress Scale From Baseline [6 Months]

    Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, &Johnson, 2016). The self-report scale consists of 21 items in 4 domains: "my partner's diabetes management", "how best to help", "diabetes & me", & "hypoglycemia". Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care & lower satisfaction with relationship

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >18

• HbA1c>8.5

• Social support person identified and contacted

Exclusion Criteria:

• unable to consent

• does not speak/read English or Spanish

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC+USC Medicine Center Emergency Department	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 22, 2018
• Statistical Analysis Plan - Jun 4, 2021
• Informed Consent Form - Jan 22, 2018

More Information

Publications

None provided.

• Responsible Party: Elizabeth Burner, Assistant Professor of Clinical Emergency Medicine, University of Southern California
• ClinicalTrials.gov Identifier: NCT03178773
• Other Study ID Numbers: HS-17-00406
• First Posted: Jun 7, 2017
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elizabeth Burner, Assistant Professor of Clinical Emergency Medicine, University of Southern California: mobile health; social support; health disparity; Latino

Study Results

Participant Flow

Arm/Group Title	TExT-MED Only	TExT-MED+FANS
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Period Title: Overall Study
STARTED	86	80
3month Phone Follow up	49	51
6month in Person Follow up	54	46
9month Follow up Phone	36	51
COMPLETED	47	40
NOT COMPLETED	39	40

Baseline Characteristics

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Total of all reporting groups
Overall Participants	86	80	166
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	50.7	47.7	48.9
Sex: Female, Male (Count of Participants)
Female	49 57%	35 43.8%	84 50.6%
Male	37 43%	45 56.3%	82 49.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	82 95.3%	74 92.5%	156 94%
Not Hispanic or Latino	3 3.5%	6 7.5%	9 5.4%
Unknown or Not Reported	1 1.2%	0 0%	1 0.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 2.3%	3 3.8%	5 3%
Asian	2 2.3%	0 0%	2 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 3.5%	6 7.5%	9 5.4%
White	40 46.5%	34 42.5%	74 44.6%
More than one race	2 2.3%	1 1.3%	3 1.8%
Unknown or Not Reported	37 43%	36 45%	73 44%
Region of Enrollment (participants) [Number]
United States	86 100%	80 100%	166 100%
Language Preferred (Count of Participants)
Spanish	64 74.4%	52 65%	116 69.9%
English	22 25.6%	28 35%	50 30.1%
Born outside US (Count of Participants)
Count of Participants [Participants]	75 87.2%	56 70%	131 78.9%
HbA1c (% percentage of hemoglobin glycosylated) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [% percentage of hemoglobin glycosylated]	10.3	10.6	10.4
BMI (kg^m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg^m2]	30.78 (7.96)	29.34 (7.18)	30.07 (7.60)
Abdominal circumference (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	138.67 (174.29)	104.82 (16.61)	122.90 (128.63)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	131.55 (25.02)	131.03 (28.90)	131.30 (26.88)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	79.98 (15.81)	81.61 (16.15)	80.77 (15.95)
Summary of Diabetes Self-Care Activities (units on a scale) [Mean (Standard Deviation) ]
Following a generally healthy diet	3.38 (2.44)	3.07 (2.51)	3.23 (2.47)
Following a disease specific diet plan	3.98 (1.90)	3.74 (1.89)	3.87 (1.90)
Self-monitoring blood glucose as advised by a h	2.55 (2.79)	2.76 (3.06)	2.65 (2.92)
Checking feet daily for wounds	4.01 (3.00)	4.11 (2.86)	4.06 (2.93)
Spacing carbohydrates throughout the day	2.78 (2.65)	3.00 (2.46)	2.89 (2.56)
Getting sufficient physical activity	2.51 (2.62)	2.43 (2.53)	2.47 (2.57)
Wilson 3 Item Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	67.16 (31.13)	65.85 (28.23)	66.53 (29.67)
Healthcare Utilization (Number of Healthcare Encounters) [Mean (Standard Deviation) ]
ED/UCC Visits	2.45 (2.12)	2.38 (3.29)	2.42 (2.74)
Hospitalization	0.43 (0.80)	0.44 (0.78)	0.43 (0.79)
Clinic Visits Made	3.28 (5.61)	2.74 (5.25)	3.02 (5.43)
Diabetes Empowerment Scale Short Form (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	30.50 (5.56)	31.09 (4.99)	30.78 (5.28)
Diabetes Distress Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.32 (0.86)	2.60 (1.11)	2.46 (0.10)
Patient Health Questionnaire 9 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.90 (6.94)	9.45 (6.31)	9.16 (6.63)
Fatalism (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.09 (9.90)	35.86 (9.85)	34.94 (9.89)
WHO Quality of life (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	61.91 (26.59)	58.00 (29.48)	60.02 (28.00)
Diabetes Family Behavior Checklist (units on a scale) [Mean (Standard Deviation) ]
Supportive	23.65 (9.12)	24.56 (9.32)	24.09 (9.20)
Non-Supportive	18.27 (7.23)	19.28 (7.22)	18.75 (7.22)
Diabetes Care Profile Support (units on a scale) [Mean (Standard Deviation) ]
Perceived Disease Specific Support Needs	23.22 (7.51)	24.04 (7.55)	23.61 (7.52)
Perceived Disease Specific Support Received	17.91 (8.81)	19.16 (9.06)	18.51 (8.92)
Support Attitudes	6.58 (5.50)	6.39 (4.68)	6.49 (5.11)
Norbeck Social Support Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Emotional	14.00 (3.32)	13.68 (3.15)	13.84 (3.23)
Tangible	6.83 (1.77)	7.15 (1.57)	6.99 (1.68)
Partner Distress Scale - Total (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.32 (0.94)	1.52 (0.95)	1.42 (0.95)

Outcome Measures

1. Primary Outcome

Title	Change in HBA1c From Baseline
Description	Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 of the HbA1c were collected from electronic healthcare records in the active control group. 1 intervention group patient refused blood draw at follow up.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Measure Participants	54	45
Mean (95% Confidence Interval) [%mmHg/dL]	1.42	1.34

2. Secondary Outcome

Title	Change in HBA1c From 6 Months to 12 Months
Description	Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

2 intervention group patient refused blood draw at follow up.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
Measure Participants	47	38
Mean (95% Confidence Interval) [%mmHg/dL]	-.36	.28

3. Secondary Outcome

Title	Change in BMI From Baseline
Description	Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

4 participants were not able to stand on the scale to measure weight

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	50	46	96
Mean (Standard Deviation) [kg^m2]	-7.91 (33.80)	-3.84 (22.94)	-5.96 (29.03)

4. Secondary Outcome

Title	Change in BMI From 6 Months to 12 Months
Description	Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

5 participants unable stand to provide weight

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	45	37	82
Mean (Standard Deviation) [kg^m2]	-3.38 (22.51)	4.02 (24.88)	-0.04 (23.75)

5. Secondary Outcome

Title	Change in Abdominal Circumference From Baseline
Description	A measure of central adiposity, it correlates with cardiovascular outcomes.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

abdominal circumference unable to be collected from 20 patients

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	43	37	80
Mean (Standard Deviation) [cm]	1.58 (14.70)	2.73 (22.54)	2.11 (18.62)

6. Secondary Outcome

Title	Change From Abdominal Circumference From 6 Months to 12 Months
Description	A measure of central adiposity, it correlates with cardiovascular outcomes.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

abdominal circumference not measured in 9 participants

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	44	34	78
Mean (Standard Deviation) [cm]	0.99 (5.10)	0.85 (18.51)	0.93 (12.70)

7. Secondary Outcome

Title	Change in Systolic Blood Pressure From Baseline
Description	Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	50	46	96
Mean (Standard Deviation) [mmHg]	-9.11 (30.45)	-13.07 (36.34)	-11.00 (33.28)

8. Secondary Outcome

Title	Change in Systolic Blood Pressure From 6 Months to 12 Months
Description	Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

11 patients with SBP unable to be obtained

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	41	35	76
Mean (Standard Deviation) [mmHg]	-4.95 (31.81)	2.09 (37.46)	-1.71 (34.47)

9. Secondary Outcome

Title	Change in Diastolic Blood Pressure From Baseline
Description	Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	50	46	96
Mean (Standard Deviation) [mmHg]	-0.27 (17.11)	-2.56 (20.09)	-1.36 (18.53)

10. Secondary Outcome

Title	Change in Diastolic Blood Pressure From 6 Months to 12 Months
Description	Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

11 patients with DBP unable to be obtained

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	41	35	76
Mean (Standard Deviation) [mmHg]	-0.82 (17.39)	5.20 (20.15)	1.95 (18.82)

11. Secondary Outcome

Title	Change in Summary of Diabetes Self-care Activities From Baseline
Description	Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Following a generally healthy diet	-1.55 (2.91)	-1.17 (2.69)	-1.37 (2.80)
Following a disease specific diet plan	-0.42 (2.12)	-0.78 (1.93)	-0.59 (2.03)
Self-monitoring blood glucose as advised by a h	-0.91 (3.00)	-0.10 (2.84)	-0.53 (2.94)
Checking feet daily for wounds	-1.25 (2.96)	-1.36 (2.69)	-1.30 (2.83)
Spacing carbohydrates throughout the day	-0.71 (4.34)	-0.20 (3.31)	-0.47 (3.89)
Getting sufficient physical activity	-0.39 (2.99)	-0.90 (3.14)	-0.63 (3.06)

12. Secondary Outcome

Title	Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months
Description	Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

one participant did not answer carb spacing as they did not know what that meant.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Following a generally healthy diet	0.23 (2.50)	0.96 (2.74)	0.57 (2.62)
Following a disease specific diet plan	0.29 (1.85)	0.45 (1.85)	0.36 (1.84)
Self-monitoring blood glucose as advised by a h	-0.66 (3.19)	-0.18 (2.40)	-0.44 (2.84)
Checking feet daily for wounds	-0.81 (2.64)	0.01 (1.93)	-0.43 (2.36)
Carb Spacing carbohydrates throughout the day	0.11 (4.51)	0.31 (3.89)	0.20 (4.22)
Getting sufficient physical activity	0.11 (2.97)	0.81 (2.88)	0.43 (2.94)

13. Secondary Outcome

Title	Change in Wilson 3 Item Scale From Baseline
Description	Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	-15.73 (30.87)	-12.39 (31.11)	-14.16 (30.87)

14. Secondary Outcome

Title	Change in Wilson 3 Item Scale From 6 Months to 12 Months
Description	Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

1 Participant decline to answer question

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	46	40	86
Mean (Standard Deviation) [units on a scale]	1.74 (18.92)	3.22 (22.89)	2.43 (20.75)

15. Secondary Outcome

Title	Change in Healthcare Utilization From Baseline
Description	Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

166 patients who initially enrolled followed in EMR

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	86	80	166
ED/UCC Visit	1.47 (1.87)	.88 (2.22)	1.18 (2.06)
Hospitalization	0.24 (.72)	.13 (.96)	.19 (.84)
Clinic Visits Made	-.97 (3.87)	-2 (6.45)	-1.46 (5.28)

16. Secondary Outcome

Title	Change in Healthcare Utilization From 6 Months to 12 Months
Description	Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

all patients initially enrolled in trial followed in EMR

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	86	80	166
ED/UCC Visit	0.07 (1.35)	.05 (1.57)	.06 (1.46)
Hospitalization	-.02 (.65)	0 (.83)	-.01 (.74)
Clinic Visits Made	1.10 (4.30)	.88 (6.30)	.99 (5.34)

17. Secondary Outcome

Title	Change in Diabetes Empowerment Scale Short Form From Baseline
Description	Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	-0.17 (0.63)	-0.05 (0.69)	-0.11 (0.66)

18. Secondary Outcome

Title	Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months
Description	Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Mean (Standard Deviation) [units on a scale]	0.13 (0.49)	-0.03 (0.54)	0.05 (0.52)

19. Secondary Outcome

Title	Change in Diabetes Distress Scale From Baseline
Description	Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	0.65 (0.97)	0.60 (1.15)	0.63 (1.06)

20. Secondary Outcome

Title	Change in Diabetes Distress Scale From 6 Months to 12 Months
Description	Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Mean (Standard Deviation) [units on a scale]	0.06 (0.92)	-0.01 (0.71)	0.03 (0.83)

21. Secondary Outcome

Title	Change in Patient Health Questionnaire 9 From Baseline
Description	Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 1 participant decline to answer question

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	51	46	97
Mean (Standard Error) [units on a scale]	3.86 (6.19)	2.33 (6.20)	3.13 (6.21)

22. Secondary Outcome

Title	Change in Patient Health Questionnaire 9 From 6 Months to 12 Months
Description	Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

2 participants decline to answer questions

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	45	40	85
Mean (Standard Deviation) [units on a scale]	-0.18 (6.86)	-0.13 (5.17)	-0.15 (6.09)

23. Secondary Outcome

Title	Change in Fatalism From Baseline
Description	Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	50	46	96
Mean (Standard Deviation) [units on a scale]	-1.44 (9.47)	0.58 (10.61)	-0.47 (10.03)

24. Secondary Outcome

Title	Change in Fatalism From 6 Months to 12 Months
Description	Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

5 participants decline to answer questions

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	44	38	82
Mean (Standard Deviation) [units on a scale]	-1.30 (8.97)	-1.20 (8.51)	-1.26 (8.70)

25. Secondary Outcome

Title	Change in WHO Quality of Life From Baseline
Description	Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	-9.69 (31.47)	-4.96 (29.86)	-7.47 (30.66)

26. Secondary Outcome

Title	Change in WHO Quality of Life From 6 Months to 12 Months
Description	Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Mean (Standard Deviation) [units on a scale]	0.09 (34.02)	6.30 (29.90)	2.94 (32.16)

27. Secondary Outcome

Title	Change in Diabetes Family Behavior Checklist - Supportive From Baseline
Description	Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	.58 (7.99)	.12 (9.08)	.36 (8.48)

28. Secondary Outcome

Title	Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months
Description	Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

patients who achieved follow up at 12 months

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Mean (Standard Deviation) [units on a scale]	-.70 (7.87)	-.98 (9.32)	-.83 (8.52)

29. Secondary Outcome

Title	Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline
Description	Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Mean (Standard Deviation) [units on a scale]	.58 (6.25)	.56 (6.86)	.57 (6.51)

30. Secondary Outcome

Title	Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months
Description	Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

patients who achieved follow up at 12 months

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Mean (Standard Deviation) [units on a scale]	-.85 (6.10)	-1.13 (6.93)	-.98 (6.46)

31. Secondary Outcome

Title	Change in Diabetes Care Profile Support From Baseline
Description	Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	52	46	98
Perceived Disease Specific Support Needs	4.44 (10.79)	5.80 (9.06)	5.08 (9.99)
Perceived Disease Specific Support Received	-0.08 (9.68)	-3.65 (9.11)	-1.76 (9.54)
Support Attitudes	0.96 (6.51)	-0.87 (5.73)	0.10 (6.20)

32. Secondary Outcome

Title	Change in Diabetes Care Profile Support From 6 Months to 12 Months
Description	Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	40	87
Perceived Disease Specific Support Needs	-0.38 (8.17)	0.40 (10.31)	-0.02 (9.17)
Perceived Disease Specific Support Received	-1.38 (7.54)	2.70 (8.17)	0.49 (8.06)
Support Attitudes	-0.77 (4.56)	0.08 (4.01)	-0.38 (4.31)

33. Secondary Outcome

Title	Change in Norbeck Social Support Questionnaire From Baseline
Description	Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

10 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	47	41	88
Emotional	0.64 (4.02)	-0.22 (4.41)	0.24 (4.20)
Tangible	0.06 (1.99)	-0.29 (2.02)	-0.10 (2.00)

34. Secondary Outcome

Title	Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months
Description	Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

2 participants decline to answer question

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	46	39	85
Emotional	-0.48 (4.03)	0.69 (4.01)	0.06 (4.04)
Tangible	-0.36 (2.17)	0.48 (2.08)	0.02 (2.16)

35. Secondary Outcome

Title	Change in Partner Distress Scale From Baseline
Description	Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, &Johnson, 2016). The self-report scale consists of 21 items in 4 domains: "my partner's diabetes management", "how best to help", "diabetes & me", & "hypoglycemia". Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care & lower satisfaction with relationship
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Supporters who were reached for follow up at 6 months

Arm/Group Title	TExT-MED Only	TExT-MED+FANS	Total
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support	Both arms combined
Measure Participants	62	54	116
Mean (Standard Deviation) [units on a scale]	.45 (0.83)	.13 (.89)	.37 (.89)

Adverse Events

Time Frame	1 year
Arm/Group Title	TExT-MED Only		TExT-MED+FANS
Arm/Group Description	Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form. TExT-MED: messages designed to inspire motivation and behavior change		Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content. TExT-MED: messages designed to inspire motivation and behavior change FANS: SMS delivered messages to family members to improve social support
All Cause Mortality
	TExT-MED Only		TExT-MED+FANS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		1/80 (1.3%)
Serious Adverse Events
	TExT-MED Only		TExT-MED+FANS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/86 (24.4%)		19/80 (23.8%)
Endocrine disorders
Report of Hypoglycemic events	21/86 (24.4%)	32	19/80 (23.8%)	24
Other (Not Including Serious) Adverse Events
	TExT-MED Only		TExT-MED+FANS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/80 (0%)

Limitations/Caveats

Follow up rates were lower than anticipated

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.