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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905575
• Other study ID #: 2023 H0010
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: Jie Hu, PhD
• Phone: 614-688-0394
• Email: hu.1348[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 receive 1) 14 session 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. All participants will be assessed at baseline, post-intervention and six months after intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 > 7.5% at time of enrollment;

• Being able to speak and read English;

• Being able to walk;

• Having an adult family member 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;

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Family dyad diabetes intervention
The goals of the intervention are to encourage participants to (1) daily self-manage diabetes and stress; (2) establish a healthy eating pattern; (3) engage in brisk walking of 150 or more minutes a week; and (4) use solution-focused problem-solving strategy and supportive family communication skills.

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diabetes control	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.	Baseline (T1) to immediate post-intervention at month 5 (T2)
Primary	Change in diabetes control	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.	Baseline (T1) to six months after intervention (T3) at month 11
Primary	Change in health-related quality of life	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.	Baseline (T1) to immediate post-intervention at month 5 (T2)
Primary	Change in health-related quality of life	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.	Baseline (T1) to six months after intervention (T3) at month 11
Secondary	Change in blood pressure control	Change in blood pressure will be measured with average scores of systolic and diastolic pressures.	Baseline (T1) to immediate post-intervention at month 5 (T2)
Secondary	Change in blood pressure control	Change in blood pressure will be measured with average scores of systolic and diastolic pressures.	Baseline (T1) to six months after intervention (T3) at month 11