RECRUITING

Transforming Hemodialysis-Related Vascular Access Education

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.

Official Title

Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Quick Facts

Study Start:2023-12-05
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05997875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 years or older
  2. 2. Nephrology visit for chronic kidney disease during the last 18 months
  3. 3. Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
  4. 4. Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
  1. 1. Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
  2. 2. Previous placement of an AV access
  3. 3. Prior or scheduled appointment with surgeon for AV access evaluation or creation
  4. 4. Cognitive dysfunction or severe visual impairment that prevents use of the education materials
  5. 5. Does not speak either English or Spanish

Contacts and Locations

Study Contact

Leah Bernardo
CONTACT
+1 215-746-4755
lleah@pennmedicine.upenn.edu
Clara Walling
CONTACT
clara.walling@pennmedicine.upenn.edu

Principal Investigator

Laura M. Dember, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Jennifer E. Flythe, MD, MPH
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Deidra Crews, MD, ScM
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Laura M. Dember, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Jennifer E. Flythe, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill
  • Deidra Crews, MD, ScM, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Kidney Disease
  • Hemodialysis Vascular Access