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Behavioural Intervention

Kidney Health Coaching for Kidney Disease (CLARIFy-KD Trial)

N/A
Waitlist Available
Led By Kimberly R Jacob Arriola, PhD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and over
Two estimated glomerular filtration rates (eGFRs) < 29 separated by at least 90 days but within the past 2 years or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years
Must not have
Currently receiving hospice care or other types of conservative management for terminal illness
Kidney or another solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to develop and implement tools to help identify and support patients with advanced chronic kidney disease. The project also aims to test new interventions to address structural racism contributing to kidney health disparities and collaborate with

Who is the study for?
This trial is for individuals with advanced chronic kidney disease (CKD). It's designed to help those affected by structural racism that contributes to kidney health disparities. Participants should be interested in engaging with community-based interventions and willing to follow a new clinical decision support system.
What is being tested?
The study tests a kidney health coaching (KHC) intervention against usual care, aiming to streamline patient care for CKD. The goal is to see if KHC can delay the need for kidney replacement therapy, prevent the use of central venous catheters, or reduce mortality rates.
What are the potential side effects?
Since this trial involves health coaching rather than medication, traditional side effects are not expected. However, participants may experience changes in their healthcare routine which could affect their daily life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function tests show a high risk of failure within 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently in hospice care or receiving conservative management for a terminal illness.
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I have had a kidney or another solid organ transplant.
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I am currently receiving dialysis.
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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time of disease progression to intervention
Secondary study objectives
CKD Symptom Burden Scale
CKD treatment Knowledge
Decisional conflict scale
+9 more
Other study objectives
Mental Health Score
Number of participants that experienced healthcare discrimination
Social Risk Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention: Kidney Health CoachingExperimental Treatment1 Intervention
Participants will receive patient-centered health coaching delivered by two full-time kidney health coaches for six months.
Group II: Control: Usual CareExperimental Treatment1 Intervention
Participants will receive usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,331,867 Total Patients Enrolled
James T. Laney School of Graduate StudiesUNKNOWN
Emory UniversityLead Sponsor
1,701 Previous Clinical Trials
2,604,131 Total Patients Enrolled
~400 spots leftby Dec 2027