Transforming Hemodialysis-Related Vascular Access Education (THRiVE)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Leah Bernardo
lleah@pennmedicine.upenn.edu
+1 215-746-4755
Backup
Clara Walling
clara.walling@pennmedicine.upenn.edu
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 360
Treatments
Experimental: Education
Experimental: Education-Plus
Other: Usual Care
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Johns Hopkins University, University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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