Clinical trial NCT05905575: A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
Official title: A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This two-arm randomized controlled trial (RCT) will test the feasibility, acceptability and efficacy of a family-dyad-focused intervention. A convenience sample will be recruited at clinics/pharmacy at Central Ohio. We will enroll a total of 208 participants in the study with104 African-Americans with T2D and one family member of each patient (104 patient-family member dyads). Patients with T2D will be randomized 1:1 to the intervention or control arm (n=52/arm). The family member of each patient will receive the same treatment as that assigned to the patient.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in diabetes control
timeFrame: Baseline (T1) to immediate post-intervention at month 5 (T2)
measure: Change in diabetes control
timeFrame: Baseline (T1) to six months after intervention (T3) at month 11
measure: Change in health-related quality of life
timeFrame: Baseline (T1) to immediate post-intervention at month 5 (T2)
measure: Change in health-related quality of life
timeFrame: Baseline (T1) to six months after intervention (T3) at month 11
Secondary outcomes:
measure: Change in blood pressure control
timeFrame: Baseline (T1) to immediate post-intervention at month 5 (T2)
measure: Change in blood pressure control
timeFrame: Baseline (T1) to six months after intervention (T3) at month 11
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
References: