Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Patient and Community Stakeholder Interviews

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: Aim 11 intervention
Group B: Aim 21 intervention
Group C: Aim 31 intervention

Trial outcomes

Primary outcomes

1

Systolic blood pressure (SBP)

Blood pressure readings will be obtained using automated BP monitors

Time frame
Baseline
2

Hemoglobin A1c (HbA1c)

Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.

Time frame
Baseline
3

LDL cholesterol

Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.

Time frame
Baseline
4

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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Medical College of Wisconsin

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator