Individualized basic need navigation and lifestyle coaching for Diabetic Nephropathies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medical College of Wisconsin, Milwaukee, WI
Diabetic Nephropathies+5 More
Individualized basic need navigation and lifestyle coaching - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Diabetic Nephropathies
  • Chronic Kidney Disease (CKD)
  • Diabetes Mellitus, Type 2
  • Healthy Lifestyle Behaviors

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Change in baseline self-care behavior at 6 months post intervention follow-up

Month 6
Hemoglobin A1c (HbA1c)
Month 6
LDL cholesterol
Month 6
Quality of Life (QOL)
Month 6
Systolic blood pressure (SBP)
Month 6
Self-Care Behavior

Trial Safety

Trial Design

2 Treatment Groups

Control group
1 of 2
Intervention Group
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Individualized basic need navigation and lifestyle coaching · No Placebo Group · Phase 2

Intervention GroupExperimental Group · 2 Interventions: Individualized basic need navigation and lifestyle coaching, Individualized basic need navigation and lifestyle coaching and skills training · Intervention Types: Behavioral, Behavioral
Control group
Behavioral
ActiveComparator Group · 1 Intervention: Enhanced usual care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in baseline self-care behavior at 6 months post intervention follow-up

Trial Background

Prof. Mukoso N. Ozieh, Assistant Professor
Principal Investigator
Medical College of Wisconsin
Closest Location: Medical College of Wisconsin · Milwaukee, WI
Photo of medical college of wisconsin  1Photo of medical college of wisconsin  2Photo of medical college of wisconsin  3
2006First Recorded Clinical Trial
1 TrialsResearching Diabetic Nephropathies
555 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have type 2 diabetes (T2DM) with HbA1c≥8.0% (7.
You are self-reported as NHB.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.