Status:
COMPLETED
Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Medication Adherence
Kidney Transplantation
Eligibility:
All Genders
12-24 years
Phase:
NA
Brief Summary
Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young childre...
Detailed Description
This entry describes Stage 3 of the study. In Stage 3, the adapted intervention and new e-pillbox and adherence-tracking website will be piloted in preparation for a definitive cluster-randomized tria...
Eligibility Criteria
Inclusion
- Patient Inclusion Criteria
- kidney-only transplant recipients, who are ≥3 months post-transplant
- Aged 12 to 24 years
- Patients followed at one of the study sites
- Patient Exclusion Criteria
- Patients with significant neurocognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents and the healthcare team)
- Patients unable to communicate in English or French (Montreal sites only)
- Multi-organ transplant recipients
- Patient has a sibling participating in Stage 3
- Patients with no internet access
- Parents Inclusion Criteria • Parent of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center) will be eligible
- Parents Exclusion Criteria
- • Parents of patients 18-24 years old will be excluded as the older aged group is expected to be primarily responsible for their own care, independent of their parents. One parent per family will be eligible to avoid redundant representation.
- Health Care Professionals Inclusion Criteria
- Representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center.
- HCP from adherence intervention sites
Exclusion
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04288271
Start Date
February 4 2022
End Date
June 30 2023
Last Update
March 15 2024
Active Locations (8)
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1
St-Louis Children's Hospital
St Louis, Missouri, United States, 63110-1002
2
Temple University
Philadelphia, Pennsylvania, United States, 19140-5102
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2536
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105-3901