Education and Coaching for Kidney Disease

(CHECK-D Trial)

Recruiting at 10 trial locations

Overseen By Ying-Jen Lin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

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

Compensation: Varies

Number of Visits: 8

420 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 Encounter Decision Intervention (EDI), Health Coaching, Pre-transplant Health Coaching, Health Coaching Intervention for kidney disease?

Research shows that tailored education and coaching programs, like the Your Path to Transplant program, can improve patients' readiness and knowledge about kidney transplants, leading to better outcomes such as increased readiness for living donor kidney transplants and improved transplant knowledge. ^{1 2 3 4 5}

Is the Education and Coaching for Kidney Disease treatment safe for humans?

The available research does not provide specific safety data for the Education and Coaching for Kidney Disease treatment, but similar educational and coaching interventions have been used in kidney transplant settings without reported safety concerns. ^{2 5 6 7 8}

How is the Education and Coaching for Kidney Disease treatment different from other treatments for kidney disease?

This treatment is unique because it combines education and personalized health coaching to improve patients' understanding and decision-making about kidney transplants, using motivational interviewing and tailored interventions to enhance readiness and knowledge, especially for those from diverse backgrounds. ^{1 2 5 9 10}

What is the purpose of this trial?

This trial uses a special educational worksheet and health coaching to help CKD patients manage their condition better. The study aims to see if this approach improves their blood pressure and overall health. Patients receive personalized information and periodic phone calls with a health coach.

Research Team

Julie Wright, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Development and Validation of the Kidney Transplant Understanding Tool (K-TUT). [2020]

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

Intervening on health literacy by knowledge translation processes in kidney transplantation: A feasibility study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to evaluate and assess the effect of comprehensive pre-end stage kidney disease education on home dialysis use in veterans, rationale and design. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

A patient navigator and education program for increasing potential living donors: a comparative observational study. [2022]

5. United States 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. [2023]

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

Communicating About Choices in Transplantation (COACH). [2019]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients. [2020]

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

Education for patients with progressive CKD and acute-start dialysis. [2013]

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

A randomized controlled trial of Explore Transplant at Home to improve transplant knowledge and decision-making for CKD 3-5 patients at Kaiser Permanente Southern California. [2020]