Educational Strategies for Advanced Kidney Disease

(THRiVE Trial)

Recruiting at 1 trial location

Overseen By Clara Walling

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Peritoneal dialysis, Preemptive transplant, Cognitive dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with advanced chronic kidney disease prepare for hemodialysis by identifying the best educational methods for vascular access. Participants are divided into three groups to test different educational approaches: one group receives only educational materials (culturally and linguistically tailored cancer education materials), another receives materials plus coaching sessions (motivational interviewing), and the last group receives standard guidance from their healthcare team (usual care). This trial suits those who have discussed hemodialysis with their doctor and have a recent kidney function test showing significant decline. Participants will share their experiences through questionnaires and interviews over about a year, with most activities occurring in the first three months. As an unphased trial, this study offers a unique opportunity to enhance educational strategies for future 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 seems focused on educational strategies rather than medication changes.

What prior data suggests that these educational strategies are safe for patients with advanced kidney disease?

Research has shown that educational materials for people with chronic kidney disease (CKD) are safe and help raise awareness. These materials can enhance understanding of CKD and lead to better health outcomes, with no reports of negative effects from their use.

Motivational interviewing is another safe approach for managing chronic conditions like kidney disease. Studies have found it helps patients adhere to their treatment plans and improve their quality of life. This method effectively motivates and engages individuals in their healthcare. Overall, both educational materials and motivational interviewing are well-received and have no known safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for educational strategies in managing advanced kidney disease because it explores how knowledge and motivation can directly impact patient outcomes. Unlike traditional treatments that focus on medication or dialysis, this approach emphasizes empowering patients with information and one-on-one motivational interviewing. The idea is that by enhancing patients' understanding and motivation, they can make more informed health decisions, potentially improving their quality of life and management of the disease. This approach could lead to more personalized and effective care, making it a promising area of exploration.

What evidence suggests that this trial's educational strategies could be effective for advanced kidney disease?

This trial will compare different educational strategies for advanced kidney disease. Participants in the "Education" arm will receive educational materials, which studies have shown can greatly increase awareness and understanding of chronic kidney disease (CKD). For example, using videos and pamphlets has effectively helped patients learn more about CKD, leading to fewer healthcare visits and better health outcomes.

Participants in the "Education-Plus" arm will receive both educational materials and Motivational Interviewing (MI). Research has shown that MI boosts patient involvement in their treatment, helping people with CKD follow their treatment plans and improving their quality of life. The benefits of MI can last up to a year, making it a promising tool for managing kidney disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Laura M. Dember, MD

Principal Investigator

University of Pennsylvania

Jennifer Flythe, MD

Principal Investigator

University of North Carolina, Chapel Hill

Deidra Crews, MD, ScM

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced chronic kidney disease who've discussed hemodialysis with their doctor, visited a nephrologist in the last 18 months, and have specific lab results indicating severe kidney function decline. It's not for those already planning different kidney failure treatments or who can't use the educational materials due to cognitive or visual impairments.

Inclusion Criteria

I have discussed starting hemodialysis with my kidney doctor.

I have seen a kidney specialist for my chronic kidney disease in the last 18 months.

My kidney function is severely reduced or my risk of kidney failure is high.

Exclusion Criteria

I am planning treatment for kidney failure that doesn't involve regular dialysis.

I have an appointment with a surgeon for an evaluation or to create a pathway for dialysis.

You have had a previous surgery to create a blood access point.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Phase

Participants receive educational materials and support based on their assigned group: Education, Education-Plus, or Usual Care.

12 weeks

Telehealth sessions and telephone questionnaires

Follow-up

Participants are monitored for outcomes such as vascular access evaluation and decision self-efficacy.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Materials
• Motivational Interviewing
• Usual Care

Trial Overview The study compares three ways of teaching about vascular access for hemodialysis: 'Education' uses a video and brochure; 'Education-Plus' adds motivational interviews via telehealth; 'Usual Care' is what patients normally get from doctors. Participants will be randomly assigned to one method and share feedback through questionnaires and possible interviews.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 2 Interventions

Group II: Education-Plus Experimental Treatment 4 Interventions

Group III: Education Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Patient education is crucial for improving outcomes in individuals with progressive kidney disease, but various barriers such as low health literacy, limited information availability, and provider time constraints hinder its implementation in the U.S.

Innovative educational strategies, including self-management support and community engagement, show promise in enhancing patient education, particularly for those with advanced kidney disease, despite challenges in evaluating their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating Patients about CKD: The Path to Self-Management and Patient-Centered Care. Narva, AS., Norton, JM., Boulware, LE.[2022]

Increasing awareness and understanding of home dialysis options among patients with advanced chronic kidney disease (CKD) is crucial for improving its utilization in the U.S.

Targeted patient education before kidney failure can significantly enhance knowledge about kidney disease and promote informed choices regarding home dialysis, but the lack of standardized education protocols leads to inconsistent outcomes in home dialysis implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Shukla, AM., Cavanaugh, KL., Jia, H., et al.[2023]

Empowering and educational initiatives significantly improve the quality of life for renal patients, impacting both psychosocial and functional aspects, which is crucial for overall patient care.

Patients who receive home care and self-care training in hemodialysis show better quality of life, reduced medical service utilization, and higher satisfaction with care, highlighting the benefits of patient education and empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there data to support the concept that educated, empowered patients have better outcomes? Latham, CE.[2019]

The Empowerment Education Program (EEP) significantly reduced uncertainty in kidney transplant patients, with improvements observed immediately after the program and four weeks later, indicating lasting effects.

Patients who participated in the EEP also showed significant increases in self-care ability and compliance with treatment, suggesting that the program effectively supports their health management post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Effects of an Empowerment Education Program for Kidney Transplantation Patients]. Kim, SH., You, HS.[2019]

The study aims to improve knowledge about conservative kidney management and advance care planning among older patients with advanced chronic kidney disease (CKD) through a pilot educational intervention called COPE, focusing on patients aged 70 and older or with poor functional status.

This randomized controlled trial will assess the effectiveness of the COPE intervention in enhancing patient knowledge and communication preferences regarding kidney management options, with outcomes measured at multiple time points over 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial. Stallings, TL., Temel, JS., Klaiman, TA., et al.[2021]

Advance care planning is often overlooked for patients with chronic kidney disease, but it can significantly enhance end-of-life care, highlighting the need for better implementation.

The MY WAY approach, which incorporates motivational interviewing and a healthcare coach, provides a structured method for patients to articulate their values and preferences regarding end-of-life care, with resources available for both patients and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Make Your Wishes About You (MY WAY): Using Motivational Interviewing to Foster Advance Care Planning for Patients with Chronic Kidney Disease. Anderson, E., Aldous, A., Lupu, D.[2019]

Engaging and empowering patients in their own care leads to better health outcomes for those on dialysis, highlighting the importance of patient involvement in treatment decisions.

Motivational interviewing is an effective technique that nephrology nurses can use to help patients take control of their care and encourage self-management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment and motivational interviewing: engaging patients to self-manage their own care. McCarley, P.[2022]

Less than 30% of patients with end-stage renal disease (ESRD) in the U.S. have received a kidney transplant, highlighting a significant gap in treatment despite the known benefits of transplantation.

Improving education for ESRD patients about kidney transplants, particularly through tailored, understandable, and culturally competent approaches, could increase patient interest and informed decision-making regarding transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying best practices to designing patient education for patients with end-stage renal disease pursuing kidney transplant. Skelton, SL., Waterman, AD., Davis, LA., et al.[2023]

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]

The iChoose Kidney mobile application is being tested in a randomized controlled trial involving approximately 450 patients to improve knowledge about the survival benefits of kidney transplantation compared to dialysis.

If successful, the iChoose Kidney app could empower patients, particularly those with low health literacy and from minority backgrounds, potentially reducing disparities in access to kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney. Patzer, RE., Basu, M., Mohan, S., et al.[2022]

The ADHERE intervention, which combines motivational interviewing and brief cognitive behavioral therapy, aims to improve symptom management and adherence to oral anti-cancer agents among cancer patients, with a study involving 65 participants across two phases.

This nurse-led program is designed to standardize patient education and support self-management at home, potentially enhancing the effectiveness of cancer treatment by empowering patients to take charge of their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial examining an advanced practice nurse intervention to promote medication adherence and symptom management in adult cancer patients prescribed oral anti-cancer agents: study protocol. Spoelstra, SL., Burhenn, PS., DeKoekkoek, T., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-kidney-diseases-8-2023-7f952

Educational Strategies for Advanced Kidney Disease The educational strategies, including motivational interviewing and tailored education, have been used safely in various health conditions, such as cancer and ...

2. researchgate.net researchgate.net/publication/393400478_Advanced_Chronic_Kidney_Disease_and_Patient_Education

Advanced Chronic Kidney Disease and Patient Education Evidence demonstrates that CKD education not only increases disease-specific knowledge, but also confers multiple benefits, including reduced healthcare ...

3. mdpi.com mdpi.com/2076-328X/14/9/750

Patients' Perspectives on the Acceptability and ... The educational intervention aimed to raise awareness about Chronic Kidney Disease (CKD) among patients with diabetes and hypertension and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39239677/

Comparison of the efficacy of educational materials for ... This study aimed to compare the efficacy of pamphlet and video materials in increasing CKD knowledge at a nephrology clinic using waiting time.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660234/

Tailoring Educational Materials to Cultural Context Matters The authors detailed how health education campaigns and interventions can facilitate chronic kidney disease (CKD) awareness among patients.

6. scholarworks.waldenu.edu scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=18221&context=dissertations

Barriers and Facilitators to Culturally Appropriate Cancer ... For example, a meta-analysis of 58 studies on the effects of health education interventions tailored to the needs of culturally and linguistically diverse (CALD) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10228681/

Interventions to support decision-making, health literacy and ... Interventions to support decision-making, health literacy and self-management in ethnic-minority adults living with chronic kidney disease: a systematic review

8. mdpi.com mdpi.com/2673-8236/5/3/32

Advanced Chronic Kidney Disease and Patient Education This review provides a comprehensive analysis of all aspects of pre-dialysis education and best practices for advanced CKD patient education.