Using mobile video to help young heart transplant patients take their medications
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant
This study tests whether using mobile videos can help young heart transplant patients remember to take their medications regularly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 4 sites (Coral Gables, Florida and 3 other locations) |
| Trial ID | NCT05732779 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a mobile video directly observed therapy (DOT) intervention aimed at improving medication adherence among adolescent heart transplant recipients. The study will randomly assign participants to receive the DOT intervention, which leverages technology to monitor and encourage adherence to immunosuppression medications. Given the high rates of non-adherence in this population, the trial seeks to address the challenges faced by youth in managing their complex post-transplant medication regimens. By promoting adherence, the study aims to reduce the risk of late acute rejection episodes and improve overall patient and graft outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10-21 who have received a heart transplant and are capable of using a mobile app for medication management.
Not a fit: Patients with cognitive impairments that prevent them from providing informed assent will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance medication adherence, leading to better health outcomes and reduced complications for adolescent heart transplant recipients.
How similar studies have performed: While there have been few successful interventions targeting medication adherence in this specific population, the use of technology in healthcare has shown promise in other settings, making this approach innovative yet somewhat untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Coral Gables, Florida and 3 other locations
- University of Miami, Miller School of Medicine — Coral Gables, Florida, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (Recruiting)
- FSU College of Medicine — Tallahassee, Florida, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Dipankar Gupta, MD — University of Florida
- Study coordinator: Dipankar Gupta, MD
- Email: dgupta@ufl.edu
- Phone: 352-273-5422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.