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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
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.
The Ohio State University College of Nursing
Columbus, Ohio, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T1) to six months after intervention (T3) at month 11
Change in blood pressure control
Change in blood pressure will be measured with average scores of systolic and diastolic pressures.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (T1) to six months after intervention (T3) at month 11