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FAMS Mobile Health Intervention for Diabetes Self-care Support

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02481596
Collaborator
(none)
512
Enrollment
1
Location
3
Arms
25.3
Actual Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: REACH + FAMS
  • Behavioral: REACH
  • Behavioral: Helpline & A1c results
 N/A

Detailed Description

Family members perform diabetes-specific behaviors that are helpful and/or harmful to the adult managing type 2 diabetes. Family behaviors are strongly associated with patients' adherence to diet and exercise: supportive family behaviors with more adherence and harmful family behaviors with less adherence. This six-month intervention seeks to increase supportive and reduce harmful family behaviors, and to improve diabetes-related self-efficacy and adherence to diet and exercise recommendations among adult patients with content that can be delivered via basic mobile phones (i.e., phone calls and text messages).

FAMS components include:

  • Six 20-30 minute coaching sessions with patient participants by phone focusing on helpful/unhelpful/desired family behaviors relevant to the patients' self-identified daily diet or exercise goal (occurs after enrollment and monthly for six months)

  • Text messages to the patient to support him/her in meeting the identified daily goal (4 per week)

  • The option to invite an adult support person to receive text messages (3 per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching

This intervention evaluation is nested within a larger randomized controlled trial (RCT; see NCT02409329) which evaluates REACH, a text messaging intervention to improve participants' adherence to self-care and glycemic control. We will evaluate these interventions with a three arm trial. Participants will be randomized to receive REACH only, REACH+FAMS, or an active control. Participants assigned to REACH+FAMS will receive the above described components for the first six months of the trial, and then REACH only until the end of the trial. Analyses will examine outcomes of FAMS at 3 and 6 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
512 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
The outcomes assessor for the primary outcome for the larger trial (NCT02409329) was blinded, but outcomes assessors for these outcomes were not.
Primary Purpose:
Supportive Care
Official Title:
Family-Focused Mobile Health Intervention: Targeting Family Behaviors to Improve Type 2 Diabetes Management Among Adults
Actual Study Start Date :
May 23, 2016
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: REACH + FAMS

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. All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.

Behavioral: REACH + FAMS
The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
Other Names:
  • Family-focused intervention

    • Behavioral: REACH
    The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
    Other Names:
  • NCT02409329

    • Behavioral: Helpline & A1c results
    Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Experimental: REACH

    Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors). All participants will receive text messages advising how to access their study A1c test results, 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, plus text messaging targeting other self-care behaviors (see NCT02409329).
    Other Names:
  • NCT02409329

    • Behavioral: Helpline & A1c results
    Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Active Comparator: Helpline & 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, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.

    Behavioral: Helpline & A1c results
    Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to Diet - Use of Dietary Information [3 months, 6 months]

      as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)

    2. Adherence to Exercise [3 months, 6 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

    3. Adherence to Diet - Problem Eating Behavior [3 months, 6 months]

      as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)

    Secondary Outcome Measures

    1. Supportive Family Behaviors [3 months, 6 months]

      as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better)

    2. Obstructive Family Behaviors [3 months, 6 months]

      as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse)

    3. Diabetes Self-efficacy [3 months, 6 months]

      as measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    *Note: Criteria for patient participants is consistent with larger study (NCT02409329).

    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

    Support persons invited to receive text messages must meet following criteria:
    Support Person Inclusion Criteria:

    • Adults aged 18 years and older

    • Identified by the patient as a part of their family (can be related biologically or legally, or be a close friend/roommate who participates in the patients' daily routine)

    Support Person Exclusion Criteria:

    • Non-English speakers (determined subjectively by a trained research assistant)

    • 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) (determined subjectively by a trained research assistant)

    • Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant)

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Lindsay Mayberry, Assistant Professor, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02481596
    Other Study ID Numbers:
    • 140562_A
    First Posted:
    Jun 25, 2015
    Last Update Posted:
    Nov 27, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Lindsay Mayberry, Assistant Professor, Vanderbilt University Medical Center
    family
    support
    diet
    exercise
    social
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 5 subjects were never reached for a required conversation prior to starting the text messaging program--they were withdrawn by the PI. 1 subject was withdrawn by the PI due to problematic behavior during enrollment.
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description 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. All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors). All participants will receive text messages advising how to access their study A1c test results, 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, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, 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, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Period Title: Overall Study
    STARTED 126 127 253
    COMPLETED 123 126 245
    NOT COMPLETED 3 1 8

    Baseline Characteristics

    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results Total
    Arm/Group Description Participants will receive FAMS components (monthly phone coaching and text messages supporting goal set in coaching, plus the option to invite a support person to receive text messages) for six months. All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors). All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and 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, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Total of all reporting groups
    Overall Participants 126 127 253 506
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    97
    77%
    109
    85.8%
    206
    81.4%
    412
    81.4%
    >=65 years
    29
    23%
    18
    14.2%
    47
    18.6%
    94
    18.6%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.7
    (10.2)
    55.8
    (9.4)
    56.1
    (9.4)
    55.9
    (9.6)
    Sex: Female, Male (Count of Participants)
    Female
    69
    54.8%
    70
    55.1%
    135
    53.4%
    274
    54.2%
    Male
    57
    45.2%
    57
    44.9%
    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
    111
    88.1%
    116
    91.3%
    224
    88.5%
    451
    89.1%
    Unknown or Not Reported
    7
    5.6%
    3
    2.4%
    14
    5.5%
    24
    4.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.8%
    0
    0%
    3
    1.2%
    4
    0.8%
    Asian
    2
    1.6%
    3
    2.4%
    3
    1.2%
    8
    1.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    0.8%
    0
    0%
    1
    0.2%
    Black or African American
    49
    38.9%
    51
    40.2%
    98
    38.7%
    198
    39.1%
    White
    63
    50%
    64
    50.4%
    128
    50.6%
    255
    50.4%
    More than one race
    5
    4%
    2
    1.6%
    6
    2.4%
    13
    2.6%
    Unknown or Not Reported
    6
    4.8%
    6
    4.7%
    15
    5.9%
    27
    5.3%
    Region of Enrollment (participants) [Number]
    United States
    126
    100%
    127
    100%
    253
    100%
    506
    100%
    Problem eating behaviors - Personal Diabetes Questionnaire (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    3.3
    3.3
    3.3
    3.3
    Use of dietary information - Personal Diabetes Questionnaire (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    2.7
    3.0
    2.7
    3.0
    MET-minutes per week - International Physical Activity Questionnaire-short form (MET-minutes per week) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [MET-minutes per week]
    1158
    1448
    1299
    1352
    Helpful involvement - Family and Friend Involvement in Adults' Diabetes (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    1.8
    1.6
    1.9
    1.8
    Harmful involvement - Family and Friend Involvement in Adults' Diabetes (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    1.6
    1.6
    1.6
    1.6
    Diabetes self-efficacy - Perceived Diabetes Self-Management Scale (units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [units on a scale]
    14
    14
    14
    14

    Outcome Measures

    1. Primary Outcome
    Title Adherence to Diet - Use of Dietary Information
    Description as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)
    Time Frame 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    3 months
    3.0
    3.3
    2.7
    6 months
    3.3
    3.3
    2.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .045
    Comments Beta=.083. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .006
    Comments Beta=.126. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    2. Primary Outcome
    Title Adherence to Exercise
    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 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    6 months
    1293
    1000
    1295
    3 months
    1251
    977
    1187
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .518
    Comments Beta=.031. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .092
    Comments Beta=.092. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    3. Primary Outcome
    Title Adherence to Diet - Problem Eating Behavior
    Description as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)
    Time Frame 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    3 months
    3.3
    3.0
    3.0
    6 months
    3.3
    3.0
    3.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .53
    Comments Beta=-.027. Threshold p<.05
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .41
    Comments Beta=-.037. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    4. Secondary Outcome
    Title Supportive Family Behaviors
    Description as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better)
    Time Frame 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    3 months
    1.8
    1.6
    1.8
    6 months
    1.8
    1.6
    1.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .024
    Comments Beta=.088. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .003
    Comments Beta=.128. Threshold p<.05
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.
    5. Secondary Outcome
    Title Obstructive Family Behaviors
    Description as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse)
    Time Frame 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    3 months
    1.4
    1.4
    1.6
    6 months
    1.3
    1.4
    1.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .001
    Comments Beta=-.133. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .012
    Comments Beta=-.115. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.
    6. Secondary Outcome
    Title Diabetes Self-efficacy
    Description as measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better)
    Time Frame 3 months, 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description REACH + FAMS: The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329). Helpline & A1c results: Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
    Measure Participants 126 127 253
    3 months
    14
    15
    14
    6 months
    15
    15
    14
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 3 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .015
    Comments Beta=.114. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection REACH + FAMS, Helpline & A1c Results
    Comments 6 months. Multiply imputed data (m=20) using chained equations.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .034
    Comments Beta=.101. Threshold p<.05.
    Method Regression, Linear
    Comments Adjusted for baseline values with cubic splines (3 knots).

    Adverse Events

    Time Frame We followed participants for 6 months of study participation, lasting from recruitment start May 2016 until the last participant completed 6-month follow-up in July 2018.
    Adverse Event Reporting Description
    Arm/Group Title REACH + FAMS REACH Helpline & A1c Results
    Arm/Group Description 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. All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence, messages assessing medication adherence with feedback, and targeted to address other self-care behaviors). All participants will receive text messages advising how to access their study A1c test results, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and 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, quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
    All Cause Mortality
    REACH + FAMS REACH Helpline & A1c Results
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/126 (0%) 1/127 (0.8%) 2/253 (0.8%)
    Serious Adverse Events
    REACH + FAMS REACH Helpline & A1c Results
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/126 (0%) 0/127 (0%) 0/253 (0%)
    Other (Not Including Serious) Adverse Events
    REACH + FAMS REACH Helpline & A1c Results
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/126 (0%) 0/127 (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.

    Results Point of Contact

    Name/Title Lindsay S. Mayberry, PhD, MS
    Organization Vanderbilt University Medical Center
    Phone 615-875-5821
    Email lindsay.mayberry@vumc.org
    Responsible Party:
    Lindsay Mayberry, Assistant Professor, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02481596
    Other Study ID Numbers:
    • 140562_A
    First Posted:
    Jun 25, 2015
    Last Update Posted:
    Nov 27, 2019
    Last Verified:
    Nov 1, 2019