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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
638
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.
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and15 months post-baseline
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 15 months post-baseline
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