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Cardiovascular Safety Measures for Chronic Kidney Failure (Dialysafe Trial)

N/A

Waitlist Available

Led By Tiffany Veinot, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

outpatient hemodialysis facilities

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Dialysafe Trial Summary

This trial is designed to reduce episodes of low blood pressure during hemodialysis in patients with End Stage Renal Disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on non-medical interventions like patient education and provider training, there are no direct medical side effects associated with drugs or procedures.

Dialysafe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I receive my dialysis treatments at an outpatient center.

Dialysafe Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dialysis Session Stability

Secondary outcome measures

Dialysis adherence - minutes missed

Dialysis adherence - sessions missed

Fluid Adherence

+5 more

Dialysafe Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Provider EducationExperimental Treatment1 Intervention

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

Group II: Patient and ProviderExperimental Treatment2 Interventions

This arm includes both Patient Activation and Provider Education interventions

Group III: Patient ActivationExperimental Treatment1 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 InterventionActive Control1 Intervention

Patients in clinic receive usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Activation

2009

N/A

~6210

Provider Education

2015

N/A

~1740

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Kidney FoundationOTHER

28 Previous Clinical Trials

83,817 Total Patients Enrolled

2 Trials studying Kidney Failure

502 Patients Enrolled for Kidney Failure

University of California, IrvineOTHER

542 Previous Clinical Trials

1,920,801 Total Patients Enrolled

Fresenius Medical Care North AmericaIndustry Sponsor

39 Previous Clinical Trials

76,974 Total Patients Enrolled

2 Trials studying Kidney Failure

116 Patients Enrolled for Kidney Failure

Media Library

Patient Activation Clinical Trial Eligibility Overview. Trial Name: NCT03171545 — N/A

Kidney Failure Research Study Groups: Patient Activation, Provider Education, No Intervention, Patient and Provider

Kidney Failure Clinical Trial 2023: Patient Activation Highlights & Side Effects. Trial Name: NCT03171545 — N/A

Patient Activation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03171545 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this scientific research currently recruiting participants?

"According to clinicaltrials.gov, this medical trial is no longer searching for patients. It was initially posted on September 1st 2023 and last updated on the 27th of September 2022; however, 824 other trials are currently looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

Tiffany Veinot 2023. "Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03171545.

All > Dialysis > Cardiovascular