Transforming Hemodialysis-Related Vascular Access Education
Recruiting · NCT05997875 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age 18 years or older
- Nephrology visit for chronic kidney disease during the last 18 months
- 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%
- Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
Exclusion criteria
- Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
- Previous placement of an AV access
- Prior appointment with surgeon for AV access evaluation or creation
- Cognitive dysfunction or severe visual impairment that prevents use of the education materials
- Does not speak either English or Spanish
Where it is running
3 locations listed across 3 US states.
- Johns Hopkins University - Baltimore, Maryland, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States