Helping African Americans with diabetic kidney disease improve their health and quality of life
Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans with Diabetic Kidney Disease
This study is testing a program that helps low-income African Americans with diabetic kidney disease by providing support and education to improve their health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05357742 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on low-income African Americans with diabetic kidney disease (DKD) who face multiple social adversities. The study aims to test the feasibility of a basic needs navigation intervention that includes education on DKD, individualized navigation for basic needs, and lifestyle coaching. Participants will be randomly assigned to either the intervention group or an enhanced usual care group, with the goal of improving clinical outcomes and self-care behaviors over a six-month follow-up period. The study will also assess the frequency and impact of various social adversities on health management.
Who should consider this trial
Good fit: Ideal candidates are low-income African American adults aged 18 and older with type 2 diabetes and chronic kidney disease who experience multiple social adversities.
Not a fit: Patients who do not identify as Black/African American or those with cognitive impairments or active substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes and quality of life for patients with diabetic kidney disease.
How similar studies have performed: While there is limited evidence on the use of patient navigator programs specifically for chronic disease management in this population, similar approaches have shown promise in improving health outcomes in low-income individuals.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. self- report as Black/African American 2. age ≥18 3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool 4. diagnosed type 2 diabetes (T2DM) with HbA1c≥8 5. chronic kidney disease (CKD) 6. able to communicate in English. Exclusion Criteria: 1. does not identify as Black/African American 2. age \<18 3. no diagnosis of T2DM and CKD 4. cognitive impairment at screening visit 5. active psychosis 6. active alcohol or drug abuse/dependency 7. life expectancy \<12 months 8. participation in other diabetes/CKD trials 9. unable to communicate in English.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Mukoso N Ozieh, MD, MSCR
- Email: mozieh@mcw.edu
- Phone: 414-955-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.