Improving education for patients needing hemodialysis access
Transforming Hemodialysis-Related Vascular Access Education (THRiVE)
This study is testing different ways to educate patients with advanced kidney disease about getting the right access for hemodialysis to see which method helps them understand and prepare the best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT05997875 on ClinicalTrials.gov |
What this trial studies
This study focuses on enhancing patient education regarding vascular access for hemodialysis in individuals with advanced chronic kidney disease. Participants will be randomly assigned to one of three educational approaches: standard education materials, enhanced education with telehealth support, or usual care provided by their healthcare team. The goal is to assess which educational method best prepares patients for the placement of hemodialysis vascular access. Participants will complete questionnaires to evaluate their understanding and preparedness throughout the process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced chronic kidney disease who have discussed hemodialysis options with their nephrologist.
Not a fit: Patients who are planning for alternative treatments like peritoneal dialysis or have already undergone vascular access placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better patient preparedness and outcomes for those undergoing hemodialysis vascular access placement.
How similar studies have performed: Other studies have shown that enhanced educational interventions can improve patient outcomes in similar contexts, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Nephrology visit for chronic kidney disease during the last 18 months 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. Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis Exclusion Criteria: 1. Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure 2. Previous placement of an AV access 3. Prior appointment with surgeon for AV access evaluation or creation 4. Cognitive dysfunction or severe visual impairment that prevents use of the education materials 5. Does not speak either English or Spanish
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Laura M. Dember, MD — University of Pennsylvania
- Study coordinator: Leah Bernardo
- Email: lleah@pennmedicine.upenn.edu
- Phone: +1 215-746-4755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.