NCT05997875 Transforming Hemodialysis-Related Vascular Access Education
| NCT ID | NCT05997875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Chronic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2023-12-05 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Laura M. Dember, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT05997875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05997875 currently recruiting?
Yes, NCT05997875 is actively recruiting participants. Contact the research team at lleah@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05997875 trial being conducted?
This trial is being conducted at Baltimore, United States, Chapel Hill, United States, Philadelphia, United States.
Who is sponsoring the NCT05997875 clinical trial?
NCT05997875 is sponsored by University of Pennsylvania. The principal investigator is Laura M. Dember, MD at University of Pennsylvania. The trial plans to enroll 360 participants.
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