A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Family dyad diabetes intervention
- Registration Number
- NCT05905575
- Lead Sponsor
- Ohio State University
- Brief Summary
A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).
- Detailed Description
Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 208
Individual with type 2 diabetes:
- Self-identification as African American;
- 40 years or older
- Type 2 diabetes diagnosis for at least six months;
- A1c > 7.0% at time of enrollment;
- Being able to speak and read English;
- Being able to walk;
- Having an adult family member/close friend willing to co-participate in the study.
Family members:
- Adults (18 years or older, with or without T2D);
- Residing in the same household as the T2D participants;
- Being a spouse, adult child or sibling; or close friend
- Being able to walk;
- Being able to speak and read English.
Individual with T2D and family members:
- Being pregnant or have an advanced or terminal condition;
- Being cognitively impaired or unable to provide informed consent;
- Lack conclusive evidence of T2D for patients with T2D.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Intervention Family dyad diabetes intervention Patient-family member dyads in the family dyad intervention arm will receive 1) 14 sessions (8 weekly and 6 biweekly) over 20 weeks of family-dyad-focused, in-person group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.
- Primary Outcome Measures
Name Time Method Change in diabetes control Baseline (T1) to six months after intervention (T3) at month 11 Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.
Change in health-related quality of life Baseline (T1) to six months after intervention (T3) at month 11 Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.
- Secondary Outcome Measures
Name Time Method Change in blood pressure control Baseline (T1) to six months after intervention (T3) at month 11 Change in blood pressure will be measured with average scores of systolic and diastolic pressures.
Trial Locations
- Locations (1)
The Ohio State University College of Nursing
🇺🇸Columbus, Ohio, United States