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

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Healthy Lifestyle; Diabetic Nephropathies; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Individualized basic need navigation and lifestyle coaching and skills training; Behavioral: Enhanced usual care

• Registration Number: NCT05357742
• Lead Sponsor: Medical College of Wisconsin

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).

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Study Start: 2022-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Individualized basic need navigation and lifestyle coaching and skills training	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.
Control group	Enhanced usual care	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	Change in baseline HbA1c at 6 months post intervention follow-up	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	Change in baseline QOL at 6 months post intervention follow-up	Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status.
LDL cholesterol	Change in baseline LDL at 6 months post intervention follow-up	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Systolic blood pressure (SBP)	Change in baseline SBP at 6 months post intervention follow-up	Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL)
Self-Care Behavior	Change in baseline self-care behavior at 6 months post intervention follow-up	Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States