Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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 participant and support person). Patients and their support person will be randomized together. Patients are encouraged to invite a support person, but it is not required. 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).

Official Title
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Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: FAMS 2.0
* Behavioral: Print Materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAMS 2.0<br>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<br>* 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.<br>* Other names: (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596);Behavioral: Print Materials<br>* Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.<br>|
| Placebo Comparator: Print Materials<br>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<br>* Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.<br>|

What is the study measuring?
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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 | as 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 | as 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 | as 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 | as 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 | as 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 100 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family support, social support, text message, mobile health, hemoglobin A1c