Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02409329
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 512
• Location: 1
• Arms: 3
• Actual Duration (Months): 36.4
• Patients Per Site Per Month: 14.1

Study Details

Study Description

Brief Summary

This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: REACH; Behavioral: Helpline and A1c results; Behavioral: REACH + FAMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 512 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
• Actual Study Start Date: May 23, 2016
• Actual Primary Completion Date: Jun 4, 2019
• Actual Study Completion Date: Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REACH Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.	Behavioral: REACH; The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.; Behavioral: Helpline and A1c results; Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Experimental: REACH + FAMS In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.	Behavioral: Helpline and A1c results; Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.; Behavioral: REACH + FAMS; The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.; Other Names: NCT02481596
Active Comparator: Helpline and A1c results Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.	Behavioral: Helpline and A1c results; Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.

Outcome Measures

Primary Outcome Measures

1. Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful

Secondary Outcome Measures

1. Change in Self-reported Medication Adherence [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence

2. Change in Self-reported Medication Adherence [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44

Other Outcome Measures

1. Change in Adherence to Dietary Behavior [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)

2. Change in Adherence to Dietary Behavior [Baseline, 3 months, 6 months, 12 months, 15 months]

   Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)

3. Change in Physical Activity [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity

4. Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control [Baseline, 3 months, 6 months, 12 months, 15 months]

   as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adults aged 18 years and older

• Individuals who have received a diagnosis for type 2 diabetes mellitus

• Enrolled as a patient at a participating community health center

• Individuals currently being treated with oral and/or injectable diabetes medications

Exclusion Criteria:

• Non-English speakers

• Individuals who report they do not have a cell phone

• Individuals unwilling and/or not able to provide written informed consent

• Individuals with unintelligible speech (e.g., dysarthria)

• Individuals with a severe hearing or visual impairment

• Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey

• Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant

• Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federally Qualified Health Centers and Vanderbilt Primary Care Clinics	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Vanderbilt University Medical Center
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Lindsay S Mayberry, MS, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 9, 2018
• Study Protocol - Apr 9, 2018

More Information

Publications

• Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
• Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.

• Responsible Party: Lindsay Mayberry, Assistant Professor of Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT02409329
• Other Study ID Numbers: 140562; 1R01DK100694-01A1
• First Posted: Apr 6, 2015
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Pre-assignment Detail	6 participants were administratively withdrawn prior to randomization; 5 were unreachable during a pre-determined run-in period after enrollment, 1 behaved inappropriately with a research assistant during enrollment

Arm/Group Title	REACH	REACH + FAMS	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Period Title: Overall Study
STARTED	127	126	253
COMPLETED	122	120	244
NOT COMPLETED	5	6	9

Baseline Characteristics

Arm/Group Title	REACH	REACH + FAMS	Helpline and A1c Results	Total
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Total of all reporting groups
Overall Participants	127	126	253	506
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	109 85.8%	97 77%	206 81.4%	412 81.4%
>=65 years	18 14.2%	29 23%	47 18.6%	94 18.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.8 (9.4)	55.7 (10.2)	56.1 (9.4)	55.9 (9.6)
Sex: Female, Male (Count of Participants)
Female	70 55.1%	69 54.8%	135 53.4%	274 54.2%
Male	57 44.9%	57 45.2%	118 46.6%	232 45.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 6.3%	8 6.3%	15 5.9%	31 6.1%
Not Hispanic or Latino	116 91.3%	111 88.1%	224 88.5%	451 89.1%
Unknown or Not Reported	3 2.4%	7 5.6%	14 5.5%	24 4.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.8%	3 1.2%	4 0.8%
Asian	3 2.4%	2 1.6%	3 1.2%	8 1.6%
Native Hawaiian or Other Pacific Islander	1 0.8%	0 0%	0 0%	1 0.2%
Black or African American	51 40.2%	49 38.9%	98 38.7%	198 39.1%
White	64 50.4%	63 50%	128 50.6%	255 50.4%
More than one race	2 1.6%	5 4%	6 2.4%	13 2.6%
Unknown or Not Reported	6 4.7%	6 4.8%	15 5.9%	27 5.3%
Region of Enrollment (participants) [Number]
United States	127 100%	126 100%	253 100%	506 100%
Hemoglobin A1c (%) (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	8.72 (1.79)	8.56 (1.90)	8.53 (1.80)	8.58 (1.82)
Medication Adherence - Summary of Diabetes Self-Care Activities medication subscale (days in a week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days in a week]	6.25 (1.37)	6.37 (1.09)	6.41 (1.16)	6.36 (1.20)
Medication Adherence - Adherence to Refills and Medications Scale for Diabetes (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	39.90 (3.74)	39.66 (3.54)	40.21 (3.34)	39.99 (3.54)
Use of dietary information - Personal Diabetes Questionnaire (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.09 (1.74)	2.85 (1.57)	2.96 (1.70)	2.97 (1.68)
Problem eating behaviors - Personal Diabetes Questionnaire (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.23 (1.08)	3.43 (1.04)	3.35 (1.16)	3.34 (1.11)
MET-minutes per week - International Physical Activity Questionnaire-short form (MET-minutes per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [MET-minutes per week]	2565.11 (3108.48)	1836.23 (2183.39)	2348.91 (2853.58)	2274.58 (2777.96)

Outcome Measures

1. Primary Outcome

Title	Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
Description	as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	8.29 (1.49)	8.59 (1.65)
6 months	8.32 (1.65)	8.57 (2.15)
12 months	8.66 (1.97)	8.70 (2.10)
15 months	8.59 (1.81)	8.61 (1.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	.0493
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.313
	Confidence Interval	(2-Sided) 95%; -0.610 to -0.017
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.260
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.070
	Confidence Interval	(2-Sided) 95%; -0.380 to 0.240
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

2. Secondary Outcome

Title	Change in Self-reported Medication Adherence
Description	as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	6.59 (0.96)	6.38 (1.25)
6 months	6.64 (0.89)	6.24 (1.51)
12 months	6.50 (1.09)	6.27 (1.46)
15 months	6.36 (1.22)	6.18 (1.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	<.001
	Comments	A priori threshold p<.05.
	Method	Wald statistic
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.406
	Confidence Interval	(2-Sided) 95%; 0.196 to 0.615
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.003
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.210
	Confidence Interval	(2-Sided) 95%; -0.031 to 0.450
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

3. Secondary Outcome

Title	Change in Self-reported Medication Adherence
Description	as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	40.4 (3.62)	40.4 (3.45)
6 months	40.6 (3.48)	40.2 (3.49)
12 months	40.3 (3.48)	40.2 (3.99)
15 months	40.5 (3.24)	40.4 (3.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.376
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.540
	Confidence Interval	(2-Sided) 95%; -0.012 to 1.090
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.434
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.278
	Confidence Interval	(2-Sided) 95%; -0.319 to 0.875
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

4. Other Pre-specified Outcome

Title	Change in Adherence to Dietary Behavior
Description	as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	3.17 (1.59)	2.84 (1.58)
6 months	3.34 (1.56)	2.93 (1.62)
12 months	3.22 (1.58)	2.88 (1.61)
15 months	3.17 (1.65)	3.01 (1.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.399
	Confidence Interval	(2-Sided) 95%; 0.160 to 0.637
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.003
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.152
	Confidence Interval	(2-Sided) 95%; -0.121 to 0.426
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

5. Other Pre-specified Outcome

Title	Change in Adherence to Dietary Behavior
Description	Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	3.17 (1.03)	3.28 (1.13)
6 months	3.11 (0.95)	3.18 (1.06)
12 months	3.09 (1.07)	3.13 (1.09)
15 months	3.18 (1.15)	3.18 (1.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.632
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.061
	Confidence Interval	(2-Sided) 95%; -0.218 to 0.095
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.572
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	0.005
	Confidence Interval	(2-Sided) 95%; -0.202 to 1.100
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

6. Other Pre-specified Outcome

Title	Change in Physical Activity
Description	as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).

Arm/Group Title	REACH	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	253	253
3 months	2285 (2973)	2139 (2501)
6 months	2332 (3168)	1991 (2547)
12 months	2573 (3329)	2273 (2883)
15 months	2221 (2973)	2239 (2774)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.703
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	369
	Confidence Interval	(2-Sided) 95%; -142 to 881
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value	0.465
	Comments	A priori threshold p<.05.
	Method	GEE, Wald test
	Comments	Adjusted for baseline values with cubic splines (3 knots).
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	26
	Confidence Interval	(2-Sided) 95%; -459 to 511
	Parameter Dispersion	Type: Value:
	Estimation Comments	15-month point estimate

7. Other Pre-specified Outcome

Title	Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
Description	as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
Time Frame	Baseline, 3 months, 6 months, 12 months, 15 months

Outcome Measure Data

Analysis Population Description

We compared participants receiving the REACH intervention only with those receiving REACH + FAMS and with participants not receiving REACH (in condition Helpline and A1c Results). This analysis was subsetted to participants with baseline HbA1c greater than or equal to 8.5% with the goal of improved power.

Arm/Group Title	REACH	REACH + FAMS	Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.	In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes	Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Measure Participants	59	52	106
3 months	9.12 (1.41)	8.98 (1.61)	9.47 (1.77)
6 months	8.88 (1.64)	9.14 (1.53)	9.74 (2.37)
12 months	9.45 (1.89)	9.57 (2.19)	9.67 (2.21)
15 months	9.28 (1.97)	9.41 (1.74)	9.57 (2.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95%; -1.38 to -0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REACH, Helpline and A1c Results
	Comments	To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -1.00 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	12-month point estimate

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Helpline and A1c Results, Helpline and A1c Results
	Comments	To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	Testing superiority of REACH_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -1.26 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments	6-month point estimate

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Helpline and A1c Results, Helpline and A1c Results
	Comments	To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.
	Type of Statistical Test	Superiority
	Comments	Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Predicted mean difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.96 to 0.51
	Parameter Dispersion	Type: Value:
	Estimation Comments	12-month point estimate

Adverse Events

Time Frame	We followed participants for 15 months of study participation, lasting from recruitment start May 2016 until the last participant completed 15-month follow-up in June 2019.
Arm/Group Title	REACH		REACH + FAMS		Helpline and A1c Results
Arm/Group Description	Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.		In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes		Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
All Cause Mortality
	REACH		REACH + FAMS		Helpline and A1c Results
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/127 (2.4%)		2/126 (1.6%)		3/253 (1.2%)
Serious Adverse Events
	REACH		REACH + FAMS		Helpline and A1c Results
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/126 (0%)		0/253 (0%)
Other (Not Including Serious) Adverse Events
	REACH		REACH + FAMS		Helpline and A1c Results
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/126 (0%)		0/253 (0%)

Limitations/Caveats

[Not Specified]

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.