Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3 (NCT04288271) | Clinical Trial Compass
CompletedNot Applicable
Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3
United States, Canada96 participantsStarted 2022-02-04
Plain-language 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 children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.
Who can participate
Age range
12 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Taking Adherence
Timeframe: 14 weeks
2
Timing Adherence
Timeframe: 14 weeks
Trial details
NCT IDNCT04288271
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre