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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient and Community Stakeholder Interviews — OTHER
    Thirty 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 — OTHER
    Three 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 — OTHER
    A 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 1
    Qualitative Aim
  • Arm: Aim 2
    Quantitative Aim
  • Arm: Aim 3
    Integrative Aim

Primary Outcome Measure

Systolic blood pressure (SBP) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
Mukoso N Ozieh, MD, MSCR
4149558839

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