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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Family dyad diabetes intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Family dyad diabetes intervention<br>* 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.<br>|
| No Intervention: Control<br>All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 |