Trial Summary
What is the purpose of this trial?
The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.
Eligibility Criteria
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.
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Treatment Details
Interventions
- Patient Activation (Behavioral Intervention)
- Provider Education (Behavioral Intervention)
Trial OverviewThe Dialysafe study aims to reduce low blood pressure episodes during hemodialysis by implementing patient activation strategies and educating healthcare providers at the clinic level.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fresenius Kidney Care University Of Michigan - Ann ArborAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Kidney FoundationCollaborator
University of California, IrvineCollaborator
Fresenius Medical Care North AmericaIndustry Sponsor