Heart Transplant RejectionNCT05732779
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
A study testing DOT intervention in people with Heart Transplant Rejection and Immune Suppression, run by University of Florida at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant
- What is being tested?
- DOT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Miami, Miller School of Medicine
Coral Gables, Florida, 33146
Olena Ashworth, MD, 801-310-9452, osa5040@med.miami.edu
Paolo Rosconi, MD
- Recruiting
University of Florida
Gainesville, Florida, 32610
Dipankar Gupta, MD, 352-273-7770, dgupta@ufl.edu
Dipankar Gupta, MD
- Recruiting
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Svetlana B Shugh, MD, 954-265-3437, sshugh@mhs.net
Svetlana B Shuh, MD
- Not yet recruiting
FSU College of Medicine
Tallahassee, Florida, 32306
Mike Killian, PhD, 850-644-7094, mkillian@fsu.edu
Sonnie Mayewski, smayewski@fsu.edu
About this study
Official title: 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
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.
Read the detailed description
Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence 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.
- Conditions
- Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant, Medication Nonadherence, Health Behavior, Remote Monitoring
- Being tested
- DOT intervention
- Medical subject headings
- Medication Adherence, Health Behavior, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOT interventionOther
A mobile health application developed by eMocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence
| Study group | Role | What they receive |
|---|---|---|
| eMocha intervention | Experimental | Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app) Receives: Other: DOT intervention |
| Standard of care | No intervention | Adolescent patients who continue enhanced goal-setting standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence based on medication level variability index
medication level variability index (MLVI). MLVI is calculated as the Standard Deviation of a set of at least 3 tacrolimus trough blood levels for each participant.
Measured: 12 weeks
Directly observed medication adherence
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Measured: 1 weeks
Late Acute Rejection
Number of biopsy-proven rejection, clinician-assigned rejection
Measured: 6 months post-intervention
Hospitalization
Number of hospitalizations
Measured: 6 months post-intervention
Patient Activation Measure
A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition
Measured: Pretest at enrollment and posttest at 12 weeks
Patient Assessment of Chronic Illness Care (PACIC)
A 20-item scale with five subscales (scale of 1 (none) to 5 (always), total score 20 to 200, higher score being better outcome) that assess patient activation, delivery system design, goal setting, problem-solving and contextual counseling, and follow-up and coordination.
Measured: Pretest at enrollment and posttest at 12 weeks
Self-reported user satisfaction with the DOT app
Collected using a modified version of the engagement index questionnaire used
Measured: Pretest at enrollment and posttest at 12 weeks
Engagement metrics
Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)
Measured: Pretest at enrollment and posttest at 12 weeks
PedsQL 3.0 Transplant Module (PedsQL-TM)
HRQOL
Measured: Pretest at enrollment and posttest at 12 weeks
Adolescent Medication Barriers Scale (AMBS)
To assess adolescent perceived barriers to medication adherence
Measured: Pretest, posttest
Parent Medication Barriers Scale (PMBS)
To assess parental perceived barriers to their child taking their medication
Measured: Pretest at enrollment and posttest at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Oct 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- emocha Mobile Health, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Dipankar Gupta, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732779
- Sponsor's protocol ID
- IRB202201809
- Other IDs
- R44HL167591-01A1
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05732779
- Acronym / sponsor ID
- IRB202201809
- Conditions
- Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant, Medication Nonadherence, Health Behavior, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- emocha Mobile Health, Inc., National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eMocha intervention | Experimental | Other: DOT interventionAdolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app) |
| Standard of care | No intervention | –Adolescent patients who continue enhanced goal-setting standard of care |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOT interventionA mobile health application developed by eMocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence | Other | eMocha intervention |
Primary outcome
Medication adherence based on medication level variability index
Time frame: 12 weeks
medication level variability index (MLVI). MLVI is calculated as the Standard Deviation of a set of at least 3 tacrolimus trough blood levels for each participant.
Directly observed medication adherence
Time frame: 1 weeks
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Late Acute Rejection
Time frame: 6 months post-intervention
Number of biopsy-proven rejection, clinician-assigned rejection
Hospitalization
Time frame: 6 months post-intervention
Number of hospitalizations
Patient Activation Measure
Time frame: Pretest at enrollment and posttest at 12 weeks
A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition
Patient Assessment of Chronic Illness Care (PACIC)
Time frame: Pretest at enrollment and posttest at 12 weeks
A 20-item scale with five subscales (scale of 1 (none) to 5 (always), total score 20 to 200, higher score being better outcome) that assess patient activation, delivery system design, goal setting, problem-solving and contextual counseling, and follow-up and coordination.
Self-reported user satisfaction with the DOT app
Time frame: Pretest at enrollment and posttest at 12 weeks
Collected using a modified version of the engagement index questionnaire used
Engagement metrics
Time frame: Pretest at enrollment and posttest at 12 weeks
Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)
PedsQL 3.0 Transplant Module (PedsQL-TM)
Time frame: Pretest at enrollment and posttest at 12 weeks
HRQOL
Adolescent Medication Barriers Scale (AMBS)
Time frame: Pretest, posttest
To assess adolescent perceived barriers to medication adherence
Parent Medication Barriers Scale (PMBS)
Time frame: Pretest at enrollment and posttest at 12 weeks
To assess parental perceived barriers to their child taking their medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dipankar Gupta, MD principal investigator
University of Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOT intervention in people with Heart Transplant Rejection and Immune Suppression, run by University of Florida at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dipankar Gupta, MD (352-273-5422, dgupta@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence based on medication level variability index (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.