Kidney Health Coaching for Kidney Disease

(CLARIFy-KD Trial)

Overseen By Kimberly R Jacob Arriola, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Dialysis, Hospice care, Transplant, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new approach called Kidney Health Coaching to support individuals with advanced chronic kidney disease (CKD). The researchers aim to determine if this coaching can delay the need for treatments such as dialysis or a central venous catheter. The study compares this coaching method to the usual care patients receive. It specifically targets African American or Black individuals who have had certain kidney function test results in the past two years and have recently been seen at Emory University Hospital-Midtown. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance kidney health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Kidney Health Coaching intervention is safe?

Research has shown that Kidney Health Coaching looks promising, but detailed safety information is not yet available. Specific reports about side effects or risks are lacking. However, health coaching is generally considered low-risk, as it focuses on guiding and supporting patients without drugs or surgery. Participants in similar programs have not reported major problems. Therefore, Kidney Health Coaching is likely safe, but solid proof specific to this treatment is still needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Kidney Health Coaching because it's a fresh approach to managing kidney disease, focusing on personalized support rather than traditional medical treatments. Unlike standard care, which often involves medications and routine monitoring, this method provides patient-centered coaching delivered by dedicated kidney health coaches over six months. This approach aims to empower patients with knowledge and skills to manage their condition effectively, potentially leading to better health outcomes and improved quality of life.

What evidence suggests that Kidney Health Coaching is effective for chronic kidney disease?

Studies have shown that health coaching can help people manage chronic kidney disease (CKD) more effectively. Research indicates that coaching improves self-care, leading to better kidney health. One study found that coaching can slow the progression of CKD, possibly delaying the need for treatments like dialysis. Additionally, coaching enhances patients' understanding of their health, enabling smarter health choices. In this trial, participants will receive either Kidney Health Coaching or usual care. These findings suggest that kidney health coaching could be a promising way to support people with CKD. ^{1 2 6 7 8}

Who Is on the Research Team?

Kimberly R Jacob Arriola, PhD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Identifies as African American or Black

Had an encounter at Emory University Hospital-Midtown through an ambulatory visit or inpatient stay (i.e. ER or hospital visit within the previous 2 months)

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Currently on waitlist or referred for or completed a transplant evaluation visit within the past 2 years

Non-English speaking

Participating in another treatment or intervention study at the time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (telephone)

Treatment

Participants receive patient-centered kidney health coaching delivered by full-time kidney health coaches for six months

6 months

Monthly check-ins (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected monthly from the EMR

6 months

Monthly data collection (EMR)

What Are the Treatments Tested in This Trial?

Interventions

• Kidney Health Coaching

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention: Kidney Health Coaching Experimental Treatment 1 Intervention

Participants will receive patient-centered health coaching delivered by two full-time kidney health coaches for six months.

Group II: Control: Usual Care Experimental Treatment 1 Intervention

Participants will receive the usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

James T. Laney School of Graduate Studies

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

10.3% of patients with chronic kidney disease (CKD) experienced adverse safety events (ASE) during hospitalization, with the most common being nausea-vomiting-diarrhea (50.7%), lower extremity edema (21.3%), and confusion (18%).

Factors such as older age, female gender, rural hospital settings, and specific comorbidities (like anemia and neurological disorders) significantly increased the odds of experiencing ASE, highlighting areas for potential intervention to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Safety Event Characteristics and Predictive Factors in Hospital Encounters for Patients with Chronic Kidney Disease. Davis-Ajami, ML., Fink, JC., Baernholdt, M., et al.[2020]

This study will evaluate the effectiveness of combining early education about chronic kidney disease (CKD) with motivational interviewing-based health coaching to improve blood pressure control in 350 patients with CKD stages 3-5 over 12 months.

The innovative approach emphasizes a multidisciplinary team and off-site coaching, aiming to enhance patient knowledge and motivation, which could lead to better health outcomes and sustainable interventions for managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. Wright Nunes, JA., Resnicow, K., Richardson, C., et al.[2023]

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39402012/

Long-Term Efficacy of an AI-Based Health Coaching ... This study aimed to evaluate the long-term efficacy of the KidneyOnline intelligent care system in slowing the progression of nondialysis-dependent CKD.

2. jmir.org jmir.org/2024/1/e54206/

Long-Term Efficacy of an AI-Based Health Coaching ... Improving kidney outcomes in patients with nondiabetic chronic kidney disease through an artificial intelligence-based health coaching ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08365-6

The effect of coaching on health information literacy in patients ... Receiving health coaching helped to improve self-management behaviors and hemoglobin levels of patients with stage 3–4 chronic kidney disease.

4. oamjms.eu oamjms.eu/index.php/mjms/article/view/5820

The Effect of Coaching Support on Kidney Function in ... Coaching support interventions were effective on kidney function in patients with CKD. The implementation of coaching support went well ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10273040/

Improving Kidney Outcomes in Patients With Nondiabetic ... The aim of this study was to evaluate the effectiveness of a mobile app–based intelligent care system in improving the kidney outcomes of patients with CKD.

6. kidney-international.org kidney-international.org/article/S0085-2538(25)00334-5/fulltext

Preventing chronic kidney disease and maintaining ... A prespecified exploratory analysis from FIDELITY examined finerenone use and kidney outcomes in patients with chronic kidney disease and type 2 diabetes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629034/

Long-Term Efficacy of an AI-Based Health Coaching ... This study aimed to evaluate the long-term efficacy of the KidneyOnline intelligent care system in slowing the progression of nondialysis-dependent CKD.

8. withpower.com withpower.com/trial/phase-kidney-diseases-2025-df56e

Kidney Health Coaching for Kidney Disease (CLARIFy-KD Trial) However, they do not provide specific safety data on Kidney Health Coaching as a treatment. Show more. How does Kidney Health Coaching differ from ...