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Recruiting NCT05732779

NCT05732779 Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

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Clinical Trial Summary
NCT ID NCT05732779
Status Recruiting
Phase
Sponsor University of Florida
Condition Heart Transplant Rejection
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2024-10-01
Primary Completion 2027-02-01

Eligibility & Interventions

Sex All sexes
Min Age 10 Years
Max Age 21 Years
Study Type INTERVENTIONAL
Interventions
DOT intervention

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 100 participants in total. It began in 2024-10-01 with a primary completion date of 2027-02-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Dipankar Gupta, MD

✉ dgupta@ufl.edu

📞 352-273-5422

Principal Investigator

Dipankar Gupta, MD

PRINCIPAL INVESTIGATOR

University of Florida

Frequently Asked Questions

Who can join the NCT05732779 clinical trial?

This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying Heart Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05732779 currently recruiting?

Yes, NCT05732779 is actively recruiting participants. Contact the research team at dgupta@ufl.edu for enrollment information.

Where is the NCT05732779 trial being conducted?

This trial is being conducted at Coral Gables, United States, Gainesville, United States, Hollywood, United States, Tallahassee, United States.

Who is sponsoring the NCT05732779 clinical trial?

NCT05732779 is sponsored by University of Florida. The principal investigator is Dipankar Gupta, MD at University of Florida. The trial plans to enroll 100 participants.

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