Finding studies
Finding studies
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Lead
Vanderbilt University Medical Center
With
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).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
