NCT03812614

Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support

Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).

Detailed description

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs): 1. coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication, 2. coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals, 3. leverage family support in the setting of other types of social support for AWDs (support from other AWDs and their family members and Community Health Workers (CHWs)) FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program. Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months. See our published protocol (Deverts et al 2022; full citation in references section) for additional details on the protocol including any changes made after the study started.

Conditions

• Diabetes Mellitus
• High Blood Pressure
• High Blood Sugar
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	FAM ACT	Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.
BEHAVIORAL	I-DSMES	Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.

Timeline

• Start date: 2019-09-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-01-23
• Last updated: 2025-02-13
• Results posted: 2025-02-13

Locations

2 sites across 1 country: United States