Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 40 years and 64 years
- Gender
- Only males
Description
The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual car...
The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. The goals of the study will be assessed under the following specific aims: Aim 1: To determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in AAW with T2DM Aim 2: To test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in AAW with T2DM compared to group-delivered, nurse led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant reductions in hemoglobin A1c at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to AAW who receive diabetes enhanced usual care Aim 3: To test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in AAW with T2DM compared to group-delivered, nurse led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant improvements in quality of life (SF-12 scores) at 6 months compared to AAW who receive diabetes enhanced usual care In the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. Findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future R01.
Tracking Information
- NCT #
- NCT04831697
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joni Williams, MD, MPH Medical College of Wisconsin