Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans Wi… (NCT05357742) | Clinical Trial Compass
CompletedNot Applicable
Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease
United States50 participantsStarted 2022-08-01
Plain-language summary
The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.
The study objective will be achieved with the following aims:
Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.
Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.
Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. self- report as Black/African American
. 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
. diagnosed type 2 diabetes (T2DM) with HbA1c≥8
. chronic kidney disease (CKD)
. able to communicate in English.
Exclusion criteria
. does not identify as Black/African American
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of the basic needs navigation intervention
Timeframe: At 6 months post intervention follow-up