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

600 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Kidney Health Coaching for Kidney Disease?

Research shows that health coaching can improve self-management and quality of life for people with chronic kidney disease by boosting their confidence and motivation to manage their health. Additionally, educational and coaching interventions have been found to help patients better control their blood pressure, which is crucial for managing kidney disease. ^{1 2 3 4 5}

Is Kidney Health Coaching safe for people with kidney disease?

The research articles focus on safety concerns related to chronic kidney disease (CKD) itself, highlighting that patients with CKD are at high risk for adverse safety events due to the complexity of their care and impaired kidney function. However, they do not provide specific safety data on Kidney Health Coaching as a treatment. ^{6 7 8 9 10}

How does Kidney Health Coaching differ from other treatments for kidney disease?

Kidney Health Coaching is unique because it focuses on empowering patients with chronic kidney disease to manage their condition through education and support, enhancing their self-efficacy (belief in their ability to manage their health) and patient activation (engagement in their own care). Unlike traditional treatments that may focus on medication or medical procedures, this approach emphasizes self-management skills and improving quality of life. ^{1 11 12 13 14}

What is the purpose of this trial?

Through the use of community-engaged processes and an anti-racism approach, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD). The overall project goals are to 1.) Design and conduct community-engaged clinical trials to test new interventions that dismantle the effects of structural racism that contribute to kidney health disparities. 2.) Foster research collaborations between investigators, people living with kidney disease, community-based organizations, and other key stakeholders. Researchers aim to assess whether the KHC intervention is effective at delaying the transition to kidney replacement therapy (KRT) and central venous catheter use or death.

Research Team

Kimberly R Jacob Arriola, PhD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

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)

Identifies as African American or Black

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

Exclusion Criteria

I am currently in hospice care or receiving conservative management for a terminal illness.

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

Non-English speaking

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mechanisms and Effects of Health Coaching in Patients With Early-Stage Chronic Kidney Disease: A Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Utilizing a disease management approach to improve ESRD patient outcomes. [2019]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of a face-to-face self-management program on knowledge, self-care practice and kidney function in patients with chronic kidney disease before the renal replacement therapy. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The Evaluation of an Orientation Program of Self-Care Abilities for Patients on Hemodialysis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Safety Event Characteristics and Predictive Factors in Hospital Encounters for Patients with Chronic Kidney Disease. [2020]

10. England pubmed.ncbi.nlm.nih.gov

"I just have to take it" - patient safety in acute care: perspectives and experiences of patients with chronic kidney disease. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Self-Management Support Prototype for Adults With Chronic Kidney Disease (My Kidneys My Health): Co-Design and Usability Testing. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The self-management experience of people with mild to moderate chronic kidney disease. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Patient activation with knowledge, self-management and confidence in chronic kidney disease. [2022]

14. England pubmed.ncbi.nlm.nih.gov

The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial. [2023]