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

Primary Purpose

Diabetic Nephropathies, Diabetes Mellitus, Type 2, Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized basic need navigation and lifestyle coaching and skills training
Enhanced usual care
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Nephropathies focused on measuring Social risk factors, Social determinants of health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. self- report as AA/Non-Hispanic Black (NHB)
  2. age ≥18
  3. screen positive for 3 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
  4. low income =<138% based on household income and household size or Medicaid eligible
  5. diagnosed type 2 diabetes (T2DM) with HbA1c≥8
  6. chronic kidney disease (CKD) stage 3 or higher
  7. able to communicate in English.

Exclusion Criteria:

  1. does not identify as AA/NHB
  2. age <18
  3. no diagnosis of T2DM and CKD
  4. end stage renal disease or renal transplant recipient
  5. cognitive impairment at screening visit
  6. active psychosis
  7. active alcohol or drug abuse/dependency
  8. life expectancy <12 months
  9. participation in other diabetes/CKD trials
  10. unable to communicate in English.

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c (HbA1c)
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.

Secondary Outcome Measures

Systolic blood pressure (SBP)
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL)
LDL cholesterol
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Quality of Life (QOL)
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status.
Self-Care Behavior
Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale

Full Information

First Posted
April 27, 2022
Last Updated
May 30, 2023
Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05357742
Brief Title
Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease
Official Title
Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Healthy Lifestyle
Keywords
Social risk factors, Social determinants of health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized basic need navigation and lifestyle coaching and skills training
Intervention Description
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
Intervention Name(s)
Enhanced usual care
Intervention Description
During each session participants will receive DKD education only.
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c)
Description
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
Time Frame
Change in baseline HbA1c at 6 months post intervention follow-up
Secondary Outcome Measure Information:
Title
Systolic blood pressure (SBP)
Description
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL)
Time Frame
Change in baseline SBP at 6 months post intervention follow-up
Title
LDL cholesterol
Description
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Time Frame
Change in baseline LDL at 6 months post intervention follow-up
Title
Quality of Life (QOL)
Description
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status.
Time Frame
Change in baseline QOL at 6 months post intervention follow-up
Title
Self-Care Behavior
Description
Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale
Time Frame
Change in baseline self-care behavior at 6 months post intervention follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukoso N Ozieh, MD, MSCR
Phone
414-955-8839
Email
mozieh@mcw.edu
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mukoso N Ozieh, Md, MSCR
Phone
414-955-8839
Email
mozieh@mcw.edu

12. IPD Sharing Statement

Learn more about this trial

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

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