NCT04347291

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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.
BEHAVIORAL	Print Materials	Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.

Timeline

• Start date: 2020-04-28
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2020-04-15
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

1 site across 1 country: United States