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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357742
• Other study ID #: PRO00041675
• Secondary ID: R21DK131356
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: Medical College of Wisconsin
• Contact: Mukoso N Ozieh, MD, MSCR
• Phone: 414-955-8839
• Email: mozieh[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this proposal is to test the feasibility and preliminary efficacy 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 test the preliminary efficacy of a basic needs navigation intervention on clinical outcomes (hemoglobin A1c, blood pressure, lipids) in low-income Africans Americans with DKD experiencing multidimensional adversity.

Hypothesis 1: Individuals randomized to the basic needs navigation intervention will have improved HbA1c at 6 months of follow-up compared to an enhanced usual care group.

Hypothesis 2: Individuals randomized to the basic needs navigation intervention will have improved blood pressure at 6 months of follow-up compared to an enhanced usual care group.

Hypothesis 3: Individuals randomized to the basic needs navigation intervention will have improved lipids at 6 months of follow-up compared to an enhanced usual care group.

Aim 3: To test the preliminary efficacy of a basic needs navigation intervention on self-care behaviors and quality of life (SF-12) in low-income Africans Americans with DKD experiencing multidimensional adversity.

Hypothesis 1: Individuals randomized to the basic needs navigation intervention will have improved self-care behaviors at 6 months of follow-up compared to an enhanced usual care group.

Hypothesis 2: Individuals randomized to the basic needs navigation intervention will have improved quality of life at 6 months of follow-up compared to an enhanced usual care group.

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. One hundred (100) 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Healthy Lifestyle
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.
• Enhanced usual care
During each session participants will receive DKD education only.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.	Change in baseline HbA1c at 6 months post intervention follow-up
Secondary	Systolic blood pressure (SBP)	Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL)	Change in baseline SBP at 6 months post intervention follow-up
Secondary	LDL cholesterol	Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.	Change in baseline LDL at 6 months post intervention follow-up
Secondary	Quality of Life (QOL)	Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status.	Change in baseline QOL at 6 months post intervention follow-up
Secondary	Self-Care Behavior	Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale	Change in baseline self-care behavior at 6 months post intervention follow-up