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

NCT ID: NCT05357742

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-07-31

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.

Detailed Description

Multidimensional adversity, defined as having three or more social adversities such as housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD and negatively impacts health outcomes. Evidence suggests patient navigation programs may be a promising strategy to improve health outcomes in low-income individuals with chronic disease. However, there is limited evidence on the use of patient navigator programs to address multidimensional adversity in individuals with chronic disease. Therefore, the primary objective of this study is to address this gap in knowledge.

Study overview: This will be accomplished using a two-arm pilot randomized control trial. Fifty (50) African American adults with DKD experiencing multidimensional adversity will be randomized into one of two arms: 1) Intervention arm and 2) Enhanced usual care arm.

Description of intervention: Participants randomized to the intervention arm will receive the manualized study intervention which includes three components 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. All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).

Control arm (Enhanced usual care arm): Participants randomized to the control arm will receive the manualized study intervention which incudes only DKD education.

All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Individualized basic need navigation and lifestyle coaching and skills training

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type: BEHAVIORAL

During each session participants will receive DKD education only.

Interventions

Individualized basic need navigation and lifestyle coaching and skills training

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 Type: BEHAVIORAL

Enhanced usual care

During each session participants will receive DKD education only.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Mukoso N. Ozieh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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. 2025 Dec 17:108183. doi: 10.1016/j.cct.2025.108183. Online ahead of print.

Reference Type: DERIVED

PMID: 41419054 (View on PubMed)

Other Identifiers

R21DK131356

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO00041675

Identifier Type: -

Identifier Source: org_study_id