RecruitingNot Applicable

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

United States100 participantsStarted 2024-10-01

Plain-language summary

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Who can participate

Age range

10 Years – 21 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: * Eligible participants are 10-21 years of age * Have received a heart transplant and are followed participating pediatric heart transplant centers * English-speaking or Spanish-speaking * Own a smart-phone or have access to the mobile app through other devices * Are willing to receive information through it * Have a MLVI score of greater than 2.0 over the last year Exclusion Criteria: • Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent

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

Medication adherence based on medication level variability index

Timeframe: 12 weeks

Directly observed medication adherence

Timeframe: 1 weeks

Late Acute Rejection

Timeframe: 6 months post-intervention

Hospitalization

Timeframe: 6 months post-intervention

Patient Activation Measure

Timeframe: Pretest at enrollment and posttest at 12 weeks

Patient Assessment of Chronic Illness Care (PACIC)

Timeframe: Pretest at enrollment and posttest at 12 weeks

Self-reported user satisfaction with the DOT app

Timeframe: Pretest at enrollment and posttest at 12 weeks

Trial details

NCT IDNCT05732779

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

Dipankar Gupta, MD

352-273-5422 dgupta@ufl.edu

View on ClinicalTrials.gov More Heart Transplant Rejection trials

Plain-language summary

Who can participate

Age range

10 Years – 21 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.

What they're measuring

Medication adherence based on medication level variability index

Timeframe: 12 weeks

Directly observed medication adherence

Timeframe: 1 weeks

Late Acute Rejection

Timeframe: 6 months post-intervention

Hospitalization

Timeframe: 6 months post-intervention

Patient Activation Measure

Timeframe: Pretest at enrollment and posttest at 12 weeks

Patient Assessment of Chronic Illness Care (PACIC)

Timeframe: Pretest at enrollment and posttest at 12 weeks

Self-reported user satisfaction with the DOT app

Timeframe: Pretest at enrollment and posttest at 12 weeks