Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Part of paid clinical trials in Milwaukee, Wisconsin.
- Sponsor
- Medical College of Wisconsin
- Study ID
- NCT05692388
- Status
- Recruiting
Conditions
- Chronic Kidney Diseases
- Diabetes Mellitus, Type 2
- Diabetic Nephropathy Type 2 - Uncontrolled
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Patient and Community Stakeholder Interviews — OTHERThirty in-depth face-to-face patient interviews, and ten in-depth structured stakeholder interviews will be conducted to explore and identify facilitators and barriers to self-care in African American adults with DKD experiencing HRSN.
- Cross-sectional Study Participants — OTHERThree hundred African American adults with DKD experiencing HRSN will be recruited to participate in a cross-sectional study. All participants will complete a one-time survey, and blood samples and blood pressure readings will be obtained to assess clinical outcomes.
- Focus Groups and Intervention Mapping — OTHERA subsample of patient interview/cross-sectional study participants will be invited back to participate in four focus groups (five participants/group) to review components of the intervention, give feedback on appropriateness, feasibility, acceptability, and likelihood of having an impact based on their lived experiences.
Study Details
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social needs (HRSN).
Key Dates
- Start date
- Jan 23, 2023
- Status verified
- Oct 2025
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 330 participants (estimated)
Arms
- Arm: Aim 1Qualitative Aim
- Arm: Aim 2Quantitative Aim
- Arm: Aim 3Integrative Aim
Primary Outcome Measure
Systolic blood pressure (SBP) [ Time Frame: Baseline ]
Central Contacts
- Mukoso N Ozieh, MD, MSCR414-955-8839
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 |
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