Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease

NCT05357742 | Completed DMC

• 2 other identifiers: PRO00041675R21DK131356
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Chronic Kidney Diseases; Healthy Lifestyle

Keywords

Social risk factors; Social determinants of health

Outcome Measures

Primary Outcomes (1)

• Feasibility of the basic needs navigation intervention

  Feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention

  At 6 months post intervention follow-up

Secondary Outcomes (4)

• Basic Needs

  At 6 months post intervention follow-up

• Hemoglobin A1c (Hb A1c)

  Change in baseline Hb A1c at 6 months post intervention follow-up

• Systolic blood pressure (SBP)

  Change in baseline SBP at 6 months post intervention follow-up

• LDL cholesterol

  Change in baseline LDL at 6 months post intervention follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants randomized to the intervention group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention.

Behavioral: Individualized basic need navigation and lifestyle coaching and skills training

Control group

ACTIVE COMPARATOR

Participants randomized to the control group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention.

Behavioral: Enhanced usual care

Interventions

Enhanced usual care BEHAVIORAL

During each session participants will receive DKD education only.

Control group

Individualized basic need navigation and lifestyle coaching and skills training BEHAVIORAL

During each session participants will receive the manualized study intervention which includes 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• does not identify as Black/African American
• age \<18
• no diagnosis of T2DM and CKD
• cognitive impairment at screening visit
• active psychosis
• active alcohol or drug abuse/dependency
• life expectancy \<12 months
• participation in other diabetes/CKD trials
• unable to communicate in English.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Ozieh MN, Patterson CG, Williams JS, Walker RJ, Egede LE. Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol. Contemp Clin Trials. 2026 Feb;161:108183. doi: 10.1016/j.cct.2025.108183. Epub 2025 Dec 17.

  PMID: 41419054 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)