A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

Last updated: December 11, 2024
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Family dyad diabetes intervention

Clinical Study ID

NCT05905575
2023 H0010
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 208
Treatment Group(s): 1
Primary Treatment: Family dyad diabetes intervention
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • The Ohio State University College of Nursing

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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