About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self- report as AA/Black
age ≥18
screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD)
Disqualifiers
cognitive impairment at screening visit
active psychosis
active alcohol or drug abuse/dependency
Trial population
Participants will include African American adults with diagnosed diabetic kidney and reporting multiple social risk factors.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Patient and Community Stakeholder Interviews
Other interventionThirty 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 interventionThree 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 interventionA 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.
Treatment groups
Trial outcomes
Primary outcomes
Systolic blood pressure (SBP)
Blood pressure readings will be obtained using automated BP monitors
Hemoglobin A1c (HbA1c)
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
LDL cholesterol
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Quality of Life (QOL)
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. This 12-item scale is a valid and reliable instrument of functional status and provides a summary physical health-related quality of life (PCS) and mental health-related quality of life (MCS). Scores for each of the PCS and MCS range from 0 to 100, with higher scores indicating better physical and mental health-related quality of life, respectively.
Sponsors and contacts
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Medical College of Wisconsin
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator