Novel Mobile Device Application to Improve Adherence (NCT02904278) | Clinical Trial Compass
CompletedNot Applicable
Novel Mobile Device Application to Improve Adherence
United States26 participantsStarted 2017-08-10
Plain-language summary
The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medication. The investigators want to find out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help adolescents take their medication according to their prescribed dosing schedule. This may then help reduce complications of transplant, such as rejection. The investigators also want to find out if how adolescent heart transplant recipients take their medications affects the development of antibodies in their blood. Antibodies are small proteins in the blood that may develop after heart transplantation, and which can sometimes damage a new heart.
Who can participate
Age range
11 Years – 17 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.
Inclusion Criteria:
* Enrolled (consented) prior to hospital discharge from heart transplantation or within one month after discharge, but not later than 3 months post-transplantation;
* English as primary language or fluent in English; and
* Informed consent and assent obtained.
Exclusion Criteria:
* Positive donor-specific cytotoxicity requiring different immunosuppressive regimen from standard care;
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
* Re-transplant or multi-organ transplant recipient;
* Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete at least one year of follow-up; or
* Current participation in other research studies that would, or might, interfere with the scientific integrity or safety of current study (e.g. by interference with immunosuppression management guidelines and study end-points).
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
Comparison of Variability in Tacrolimus Levels by Group Assignment
Timeframe: 3 months ( to 12 Months Post-Transplantation
Trial details
NCT IDNCT02904278
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)