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

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05732779
• Other study ID #: IRB202201809
• Secondary ID: R44HL167591-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: University of Florida
• Contact: Dipankar Gupta, MD
• Phone: 352-273-5422
• Email: dgupta[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Heart Transplant Rejection
• Immune Suppression
• Medication Nonadherence
• Patient Engagement
• Pediatric Heart Transplant
• Remote Monitoring

Intervention

Other:
• DOT intervention
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

Locations

Country	Name	City	State
United States	University of Miami, Miller School of Medicine	Coral Gables	Florida
United States	University of Florida	Gainesville	Florida
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	FSU College of Medicine	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	emocha Mobile Health, Inc., National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	Directly observed medication adherence	Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day	1 weeks
Primary	Late Acute Rejection	Number of biopsy-proven rejection, clinician-assigned rejection	6 months post-intervention
Primary	Hospitalization	Number of hospitalizations	6 months post-intervention
Primary	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	Pretest at enrollment and posttest at 12 weeks
Primary	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.	Pretest at enrollment and posttest at 12 weeks
Primary	Self-reported user satisfaction with the DOT app	Collected using a modified version of the engagement index questionnaire used	Pretest at enrollment and posttest at 12 weeks
Primary	Engagement metrics	Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)	Pretest at enrollment and posttest at 12 weeks
Primary	PedsQL 3.0 Transplant Module (PedsQL-TM)	HRQOL	Pretest at enrollment and posttest at 12 weeks
Primary	Adolescent Medication Barriers Scale (AMBS)	To assess adolescent perceived barriers to medication adherence	Pretest, posttest
Primary	Parent Medication Barriers Scale (PMBS)	To assess parental perceived barriers to their child taking their medication	Pretest at enrollment and posttest at 12 weeks