Cardiovascular Safety Measures for Chronic Kidney Failure

(Dialysafe Trial)

Overseen By Rajiv Saran, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Incarceration, Cognitive impairment, Language barrier, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help patients with End Stage Renal Disease (ESRD) by reducing episodes of low blood pressure during dialysis sessions. The study will test two main approaches: one focuses on patient support through peer mentorship (called Patient Activation), and the other educates care teams with training and online resources (called Provider Education). People with ESRD who regularly experience low blood pressure during dialysis might be a good fit. The trial involves various dialysis clinics, so eligibility also depends on the clinic's participation.

As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could improve dialysis care for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that patient activation, which includes peer support and motivation, is generally well-received. One study found that dialysis patients who were more engaged experienced better outcomes, such as lower death rates, suggesting safety for individuals with kidney failure.

Educating healthcare providers, involving training and checklists for care teams, also supports safety. Although specific studies on safety issues for this type of training are limited, education typically poses no risk to patients and can improve care.

Overall, both approaches emphasize support and education, making them unlikely to cause harm and considered safe for patients with chronic kidney problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these approaches because they focus on empowering both patients and healthcare providers, which is a shift from traditional medication-based treatments for chronic kidney failure. Unlike standard care, which often centers around medication and dialysis, the Patient Activation arm uses peer mentoring and motivational interviewing by experienced End Stage Renal Disease patients, providing support and practical advice directly from those who understand the challenges firsthand. The Provider Education arm introduces comprehensive team training and online resources for care teams, aiming to elevate the standard of care through better-informed and more cohesive healthcare providers. By combining these strategies, there's potential not only to improve cardiovascular safety but also to enhance overall patient engagement and care quality.

What evidence suggests that this trial's treatments could be effective for reducing intradialytic hypotension in patients with ESRD?

This trial evaluates different approaches to improving care for chronic kidney failure. One arm of the trial focuses on Patient Activation. Studies have shown that when patients become more involved in their own care, they benefit, especially those with chronic kidney disease. These efforts often lead to better coping strategies and greater satisfaction with decisions for those nearing kidney failure. Research indicates that patients who actively participate in their care usually experience better health and fewer symptoms.

Another arm of the trial focuses on Provider Education. Research suggests that educating care teams can improve patient outcomes, including fewer hospital visits and smoother transitions to treatments like dialysis. Well-informed healthcare providers can support patients more effectively, enhancing overall health management and reducing complications. ^{6 7 8 9 10}

Who Is on the Research Team?

Tiffany Veinot, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adult patients with End Stage Renal Disease who are undergoing outpatient hemodialysis. Facilities must have at least 70 such patients and not be rated as poor quality, involved in other studies, designated COVID-19 isolation centers, or in immediate jeopardy.

Inclusion Criteria

I receive my dialysis treatments at an outpatient center.

I am over 21 years old.

Exclusion Criteria

individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish

I have difficulty thinking, remembering, or making decisions.

You are currently in prison.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multimodal provider education and patient activation interventions to improve dialysis session stability

48 weeks

Regular dialysis sessions, 3 times a week

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Activation
• Provider Education

Trial Overview

The Dialysafe study aims to reduce low blood pressure episodes during hemodialysis by implementing patient activation strategies and educating healthcare providers at the clinic level.

How Is the Trial Designed?

Group I: Provider Education Experimental Treatment 1 Intervention

This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.

Group II: Patient and Provider Experimental Treatment 2 Interventions

This arm includes both Patient Activation and Provider Education interventions

Group III: Patient Activation Experimental Treatment 1 Intervention

This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.

Group IV: No Intervention Active Control 1 Intervention

Patients in clinic receive usual care.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Kidney Foundation, United States

Collaborator

National Kidney Foundation

Collaborator

National Kidney Foundation

Collaborator

Trials

33

Recruited

85,800+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Fresenius Medical Care North America

Industry Sponsor

Trials

40

Recruited

78,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11043190/

Patient activation in advanced chronic kidney disease

... stages with stage 5 being kidney failure ... Dialysis modality choice in elderly patients with end-stage renal disease: a narrative review of the ...

2.

nature.com

nature.com/articles/s41746-024-01296-1

The effects of a digital health intervention on patient ...

At the primary end-point (20 weeks), there were 47% missing data, with greater proportions of missingness observed in the intervention group (51 ...

3.

sigmapubs.onlinelibrary.wiley.com

sigmapubs.onlinelibrary.wiley.com/doi/full/10.1111/wvn.12634

The effectiveness of patient activation interventions in adults ...

Coping strategies used by chronic renal failure patients on hemodialysis. ... end-stage renal disease in Taiwan: A randomized, controlled trial.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2468024925004607

Patient Activation Impacts Exercise in Older Adults With ...

Exploring the relationship between patient activation, treatment satisfaction, and decisional conflict in patients approaching end-stage renal disease. Ann ...

5.

bmcnephrol.biomedcentral.com

bmcnephrol.biomedcentral.com/articles/10.1186/s12882-022-02679-w

Patient activation and its association with symptom burden ...

In CKD, poor engagement with self-management behaviours are associated with poor clinical outcomes such as progression to end-stage kidney ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5835444/

Cardiovascular Disease in Patients with End-Stage Renal ...

Cardiovascular disease is a major concern for patients with end-stage renal disease (ESRD), especially those on hemodialysis.

7.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050686

Cardiovascular Disease in Chronic Kidney Disease

Patients with CKD exhibit a pronounced risk for cardiovascular events: 50% of all patients with CKD stage 4 to 5 have CVD, and cardiovascular ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4485595/

Patient Safety Issues in CKD - PMC - PubMed Central - NIH

Patients with chronic kidney disease (CKD) are at an inherently increased risk for adverse safety events.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03171545

Enhancing the Cardiovascular Safety of Hemodialysis ...

The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage ...

10.

journals.lww.com

journals.lww.com/kidney360/fulltext/2024/11000/associations_of_patient_activation_with_outcomes.9.aspx

Associations of Patient Activation with Outcomes among...

In a cohort of patients on prevalent, in-center hemodialysis, low activation was associated with mortality, but not with hospitalization or measures of ...