Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 488
Summary
- Conditions
- Diabetes Mellitus
- High Blood Pressure
- High Blood Sugar
- Hypertension
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized comparative effectiveness trial comparing two interventions. The participants and staff delivering the interventions will not be blinded, but the data analyst will be. This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to patient-focused DSME and care management.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 21 years and 75 years
- Gender
- Both males and females
Description
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management: Provide Support Person with core behavioral strategies, hands-on training, and tools directed at specific roles in supporting diabetes management (e.g. how to support action planning and medicati...
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management: Provide Support Person with core behavioral strategies, hands-on training, and tools directed at specific roles in supporting diabetes management (e.g. how to support action planning and medication adherence). Teach Support Person how to deliver support in ways that will empower patients and not sabotage support efforts (e.g. empathetic and autonomy-supportive communication). Teach Support Person ways to boost patient engagement in healthcare (e.g. how to support healthcare visit preparation and participatory communication with providers). CHWs will deliver FAM-ACT through Support Person-focused group DSME sessions plus Support Person-focused care management sessions to Patient-Support Person dyads at an urban federally qualified health center. When situationally appropriate, the care management sessions will be conducted by phone/video call or using a HIPAA-compliant online video-conferencing platform. 268 patients with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a member or friend (known as a Support Person) to receive either FAM-ACT or more traditional CHW-led patient-focused DSME/CM over 12 months.
Tracking Information
- NCT #
- NCT03812614
- Collaborators
- The Community Health and Social Services Center, Inc.
- University of Michigan
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: Ann-Marie Rosland, MD,MS University of Pittsburgh
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