## Protocol Section
### Identification Module
**NCT ID:** NCT05732779

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

**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

#### Organization Study ID Info
**ID:** IRB202201809
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
#### Secondary ID Infos
**ID:** R44HL167591-01A1
**Link:** https://reporter.nih.gov/quickSearch/R44HL167591-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2023-02-17
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-06
**Study First Submit QC Date:** 2023-02-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** emocha Mobile Health, Inc.

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Heart Transplant Rejection

- Immune Suppression

- Pediatric Heart Transplant

- Medication Nonadherence

- Health Behavior

- Remote Monitoring

- Patient Engagement

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)

**Intervention Names:**

- Other: DOT intervention

**Label:** eMocha intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Adolescent patients who continue enhanced goal-setting standard of care

**Label:** Standard of care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- eMocha intervention

**Description:** 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

**Name:** DOT intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Medication adherence based on medication level variability index

**Time Frame:** 12 weeks

**Description:** Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day

**Measure:** Directly observed medication adherence

**Time Frame:** 1 weeks

**Description:** Number of biopsy-proven rejection, clinician-assigned rejection

**Measure:** Late Acute Rejection

**Time Frame:** 6 months post-intervention

**Description:** Number of hospitalizations

**Measure:** Hospitalization

**Time Frame:** 6 months post-intervention

**Description:** A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition

**Measure:** Patient Activation Measure

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

**Description:** 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.

**Measure:** Patient Assessment of Chronic Illness Care (PACIC)

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

**Description:** Collected using a modified version of the engagement index questionnaire used

**Measure:** Self-reported user satisfaction with the DOT app

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

**Description:** Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)

**Measure:** Engagement metrics

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

**Description:** HRQOL

**Measure:** PedsQL 3.0 Transplant Module (PedsQL-TM)

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

**Description:** To assess adolescent perceived barriers to medication adherence

**Measure:** Adolescent Medication Barriers Scale (AMBS)

**Time Frame:** Pretest, posttest

**Description:** To assess parental perceived barriers to their child taking their medication

**Measure:** Parent Medication Barriers Scale (PMBS)

**Time Frame:** Pretest at enrollment and posttest at 12 weeks

### Eligibility Module

**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

**Maximum Age:** 21 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dgupta@ufl.edu

**Name:** Dipankar Gupta, MD

**Phone:** 352-273-5422

**Role:** CONTACT

**Contact 2:**

**Email:** dalylc@ufl.edu

**Name:** Dalia Lopez-Colon, PhD

**Phone:** 352-281-6723

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Coral Gables

**Contacts:**

***Contact 1:***

- **Email:** osa5040@med.miami.edu

- **Name:** Olena Ashworth, MD

- **Phone:** 801-310-9452

- **Role:** CONTACT

***Contact 2:***

- **Name:** Paolo Rosconi, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Miami, Miller School of Medicine

**State:** Florida

**Zip:** 33146

**Location 2:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida

**State:** Florida

**Zip:** 32610

**Location 3:**

**City:** Hollywood

**Contacts:**

***Contact 1:***

- **Email:** sshugh@mhs.net

- **Name:** Svetlana B Shugh, MD

- **Phone:** 954-265-3437

- **Role:** CONTACT

***Contact 2:***

- **Name:** Svetlana B Shuh, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Joe DiMaggio Children's Hospital

**State:** Florida

**Zip:** 33021

**Location 4:**

**City:** Tallahassee

**Contacts:**

***Contact 1:***

- **Email:** mkillian@fsu.edu

- **Name:** Mike Killian, PhD

- **Phone:** 850-644-7094

- **Role:** CONTACT

***Contact 2:***

- **Email:** smayewski@fsu.edu

- **Name:** Sonnie Mayewski

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mike Killian, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** FSU College of Medicine

**State:** Florida

**Zip:** 32306

#### Overall Officials

**Official 1:**

**Affiliation:** University of Florida

**Name:** Dipankar Gupta, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
