Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      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: 
      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).
    

Intervention name(s): FAMS 2.0; Print Materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Family/friend Activation to Motivate Self-care; (prior iteration) Family-focused Add-on to Motivate Self-care (NCT02481596)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: family support; social support; text message; mobile health; hemoglobin A1c