Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALFamily 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diabetes control | Baseline (T1) to immediate post-intervention at month 5 (T2) | 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 immediate post-intervention at month 5 (T2) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure control | Baseline (T1) to immediate post-intervention at month 5 (T2) | Change in blood pressure will be measured with average scores of systolic and diastolic pressures. |
Countries
United States
Outcome results
None listed