Education and Coaching for Kidney Disease

(CHECK-D Trial)

Enrolling by invitation at 10 trial locations

Overseen By Ying-Jen Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dialysis, Kidney transplant, Pregnant, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special educational worksheet and health coaching, known as the Encounter Decision Intervention (EDI), can assist people with chronic kidney disease (CKD) in managing their blood pressure and improving other health outcomes. Participants will receive either general information or personalized advice about kidney disease, along with coaching. The trial seeks individuals diagnosed with CKD stage 3, 4, or 5 who also have poorly controlled high blood pressure.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health management strategies for CKD patients.

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 this educational and coaching intervention is safe for CKD patients?

Research shows that tools like the Encounter Decision Intervention (EDI) can be safely used in primary care for people with chronic kidney disease (CKD). Although specific safety data is lacking, these educational tools are generally well-received and typically do not cause harm.

Health coaching for CKD patients has also proven safe in other studies. For instance, a telehealth coaching program reported no unexpected negative side effects, suggesting that health coaching is a safe way to support kidney health.

Overall, both the EDI and health coaching are expected to be safe for individuals considering participation in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Education and Coaching for Kidney Disease approach because it offers a personalized touch that standard treatments don't. Unlike typical education materials, which provide generic information, the Encounter Decision Intervention (EDI) is tailored to each patient, including specific goals and key points from their healthcare provider. Additionally, health coaching supports patients in making lifestyle changes and managing their condition more effectively. This personalized and supportive method has the potential to improve patient engagement and health outcomes in a way that standard educational resources might not.

What evidence suggests that the Encounter Decision Intervention (EDI) and health coaching are effective for improving chronic kidney disease outcomes?

Research has shown that the Encounter Decision Intervention (EDI) can increase patient satisfaction with healthcare providers. This tool helps individuals with chronic kidney disease (CKD) better understand their condition, potentially enhancing their experience during primary care visits. In this trial, participants in the intervention group will receive a personalized version of the EDI along with health coaching. Health coaching has proven effective in helping CKD patients care for their kidneys, manage their health, and maintain healthy hemoglobin levels, which are crucial for kidney health. Together, these methods may offer significant benefits for managing CKD. ^{1 6 7 8 9}

Who Is on the Research Team?

Julie Wright, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with chronic kidney disease stages 3, 4, or 5 who also have high blood pressure that hasn't been controlled well. They should know about their CKD diagnosis and have a specific level of kidney function. People can't join if they're pregnant, on permanent dialysis, had a kidney transplant, terminally ill or have cognitive issues affecting participation.

Inclusion Criteria

Aware of CKD diagnosis

My condition is chronic kidney disease stage 3, 4, or 5.

My latest blood pressure reading is 140/90 or higher.

Exclusion Criteria

Has cognitive, language, or vision impairment(s) that would prohibit participating in education, taking surveys, or participating in coaching activities

I am on permanent dialysis for end-stage kidney disease.

I have had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Eligible patients complete enrollment and receive either a Control-EDI or personalized Intervention-EDI

1 visit

1 visit (in-person)

Intervention

Intervention group receives health coaching and personalized EDI; Control group receives general EDI

11 months

4-6 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits and surveys

12 months

3 visits (in-person) at 1, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Encounter Decision Intervention (EDI)
• Health Coaching

Trial Overview The study tests whether an educational worksheet (EDI) plus health coaching can better manage blood pressure in CKD patients compared to just the EDI alone. The goal is to see if this combination leads to improved health outcomes for those with CKD.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Eligible patients enrolled from the intervention group clinics will be given an Intervention-EDI which has personalized information about kidney disease. There will be space on this for the provider to type in any goals or key points they want the patient to remember. Additionally, patients in this group will also receive health coaching.

Group II: Control Active Control 1 Intervention

Eligible patients enrolled from the control group clinics will be given a Control-EDI which has information about kidney disease in general (not tailored to the patient) during their clinic visit.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A new health literacy intervention, which included a film and motivational interviewing sessions led by dialysis nurses, was positively received by both patients and nurses, indicating its feasibility and acceptability for preparing patients for kidney transplantation.

The intervention fostered meaningful dialogue that enhanced patients' understanding and confidence, although nurses found the motivational interviewing approach challenging, highlighting the need for additional training and support for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervening on health literacy by knowledge translation processes in kidney transplantation: A feasibility study. Andersen, MH., Urstad, KH., Larsen, MH., et al.[2022]

A tailored education program called Your Path to Transplant (YPT) significantly improved readiness for living donor kidney transplants (LDKT) and transplant knowledge among 802 patients compared to standard education, with LDKT readiness increasing from 33% to 47%.

Patients in the YPT group were more likely to pursue transplants, with a 44% higher rate of waitlisting or living donor kidney transplant compared to those receiving standard care, indicating that personalized education can enhance transplant-seeking behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge, attitudes, and pursuit of kidney transplant. Waterman, AD., Peipert, JD., Cui, Y., et al.[2023]

Decision coaching, when compared to usual care, significantly improved patient knowledge regarding health decisions, as shown in a subanalysis of 10 trials from the Cochrane Review of patient decision aids.

While decision coaching combined with patient decision aids (PtDAs) enhanced values-choice agreement and satisfaction in decision-making, it did not consistently outperform PtDAs alone in terms of knowledge or participation, indicating the need for further research to clarify its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. Stacey, D., Kryworuchko, J., Bennett, C., et al.[2022]

Citations

1. ajkd.org ajkd.org/article/S0272-6386(24)01117-X/abstract

Patient Education for CKD and Decision Support in Primary ... Pilot testing suggested that the EDI was associated with higher patient satisfaction with their primary care provider, with their clinician's ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39675547/

Patient Education for CKD and Decision Support in Primary ... This pilot study found that a decision aid for patients with CKD was implementable in a primary care setting.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027263862401117X

Patient Education for CKD and Decision Support in Primary ... Pilot testing suggested that the EDI was associated with higher patient satisfaction with their primary care provider, with their clinician's communication, and ...

4. acpjournals.org acpjournals.org/doi/abs/10.7326/M22-1543

Effectiveness of an Intervention to Improve Decision ... Conclusion: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251332832

Interactive decision aid on therapy decision making for ... This study aimed to evaluate the effectiveness of an Interactive Patient-Decision-Aid App for Kidney Replacement Therapy (iPtDA-KRT App) in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772628224000086

Ensuring competency and fidelity The intervention uses scenario planning to manage uncertainty and storytelling to describe not just outcomes and risks, but how patients might experience ...

7. kireports.org kireports.org/article/S2468-0249(23)01559-0/fulltext

Clinical Decision Support Tools in the Electronic Medical ... This article reviews the history of EMR systems and its integration with CDS tools, the barriers preventing successful integration, and the benefits reported ...

8. nature.com nature.com/articles/s41598-023-50507-4

The development and internal pilot trial of a digital physical ... This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11019443/

Electronic Health Record Population Health Management for ... Large gaps in clinical care in patients with chronic kidney disease (CKD) lead to poor outcomes. Objective. To compare the effectiveness of an ...