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Recruiting NCT05692388

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

— Observational Diabetic Nephropathy Type 2 - Uncontrolled Diabetes Mellitus, Type 2 Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient and Community Stakeholder Interviews, Cross-sectional Study Participants, Focus Groups and Intervention Mapping.
Who it may be relevant to
Registry conditions: Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed description

Health-related social needs (HRSN) including loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.

Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews.

Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing HRSN.

Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.

Interventions

  • Other Patient and Community Stakeholder Interviews
    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.
  • Other Cross-sectional Study Participants
    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.
  • Other Focus Groups and Intervention Mapping
    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.

Primary outcome measures

  • Systolic blood pressure (SBP) [Time frame: Baseline]
  • Hemoglobin A1c (HbA1c) [Time frame: Baseline]
  • LDL cholesterol [Time frame: Baseline]
  • Quality of Life (QOL) [Time frame: Baseline]
  • Self-Care Behavior [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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)
  • able to communicate in English.

Exclusion criteria

  • cognitive impairment at screening visit
  • active psychosis
  • active alcohol or drug abuse/dependency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT05692388 · PRO00043301 · 1K23MD016448-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗