Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes (FAMS 2)

This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: FAMS 2.0; Behavioral: Print Materials

Detailed Description

The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:

• Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal
• Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence
• Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach
• The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text 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

Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

PATIENTS:

• Speaks and reads in English
• 18-75 years old
• Diagnosed with type 2 diabetes
• Receiving outpatient care from a partnering clinic
• Community dwelling (e.g., not in a nursing facility)
• Prescribed at least one daily diabetes medication
• Owns a mobile phone

SUPPORT PERSONS:

• Speaks and reads in English
• 18 years or older
• Owns a mobile phone

Exclusion Criteria:

PATIENTS:

• Unable to communicate by phone
• Pregnant currently
• Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
• Diagnosed with end-stage renal disease
• Receiving hospice services
• Diagnosed with congestive heart failure
• Diagnosed with dementia
• Diagnosed with schizophrenia
• Reported current abuse during screening
• Demonstrates inability to receive and respond to a text
• Does not take medication on his/her own/medication administered by someone else

SUPPORT PERSONS:

- Demonstrates inability to receive and respond to a text

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAMS 2.0; Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.	Behavioral: FAMS 2.0; FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.; Other Names: Family/friend Activation to Motivate Self-care; (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596); Behavioral: Print Materials; Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Placebo Comparator: Print Materials; All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.	Behavioral: Print Materials; Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycemic Control (Patient Participants) During Intervention Period	Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control	Baseline and 6 and 9 months post-baseline
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects	Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control	Baseline and 12 and 15 months post-baseline
Change in Diabetes Distress (Patient Participants) During Intervention Period	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)	Baseline and 6 and 9 months post-baseline
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)	Baseline and 15 months post-baseline
Change in Psychosocial Well-being (Patient Participants) During Intervention Period	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)	Baseline and 6 and 9 months post-baseline
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)	Baseline and15 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Distress (Support Person Participants) During Intervention Period	as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse)	Baseline and 6 and 9 months post-baseline
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect	Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse)	Baseline and 15 months post-baseline
Change in Support Burden (Support Person Participants) During Intervention Period	as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse)	Baseline and 6 and 9 months post-baseline
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect	as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse)	Baseline and 15 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator)	as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better)	Baseline and 6 and 9 months post-baseline
Change in Dietary Behavior (Patient Participants - Outcome & Mediator)	as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better)	Baseline and 6, 9, and 15 months post-baseline
Change in Dietary Behavior (Patient Participants - Outcome & Mediator)	as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse)	Baseline and 6, 9, and 15 months post-baseline
Change in Physical Activity (Patient Participants - Outcome & Mediator)	as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better)	Baseline and 6, 9, and 15 months post-baseline
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)	as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher better)	Baseline and 6, 9, and 15 months post-baseline
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator)	as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse)	Baseline and 6, 9, and 15 months post-baseline
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)	as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)	Baseline and 6, 9, and 15 months post-baseline
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)	as assessed by the Important Others Climate Questionnaire, specific to diabetes management, with scores ranging 1 to 5 with higher scores indicating more autonomy supportive communication (better)	Baseline and 6, 9, and 15 months post-baseline
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)	as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)	Baseline and 6, 9, and 15 months post-baseline
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator)	as assessed by the criticism items from the Family Emotional Involvement and Criticism Scale, specific to diabetes management, with scores ranging 0 to 16 with higher scores indicating more perceived criticism (worse)	Baseline and 6, 9, and 15 months post-baseline
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator)	as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)	Baseline and 6, 9, and 15 months post-baseline
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator)	as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)	Baseline and 6, 9, and 15 months post-baseline
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator)	as assessed by items from the Family Experience of Patient Involvement measure from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where a score of 2 indicates alignment between the support person's current level of involvement and their desired level of involvement. We will report change in the % aligned (reporting a 2) across conditions.	Baseline and 6, 9, and 15 months post-baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; social support; text message; family support; hemoglobin A1c
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 200398; R01DK119282 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
• IPD Sharing Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later.
• IPD Sharing Access Criteria: Contact the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No