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Novel Mobile Device Application to Improve Adherence

NCT02904278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-12-04

No results posted yet for this study

Summary

The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medication. The investigators want to find out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help adolescents take their medication according to their prescribed dosing schedule. This may then help reduce complications of transplant, such as rejection. The investigators also want to find out if how adolescent heart transplant recipients take their medications affects the development of antibodies in their blood. Antibodies are small proteins in the blood that may develop after heart transplantation, and which can sometimes damage a new heart.

Conditions

  • Pediatric Heart Transplant Recipients
  • Pediatric Cardiac Transplantation
  • Pediatric Heart Transplantation

Interventions

OTHER

Teen Pocket PATH® Mobile Application

Participants in the intervention group will receive the mobile application for improving adherence to their post-transplant medications. The intervention will prompt, remind, and warn participants when medications are due, inform parents when medication management is completed, and engage parents when no action is undertaken.

OTHER

Control Group: Standard of Care

Adolescents and parents/guardians assigned to the Standard Care Condition will receive standard clinical care per standard site procedures.

Sponsors & Collaborators

  • Clinical Trials in Organ Transplantation in Children

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Diana Shellmer, Ph.D. · Children's Hospital of Pittsburgh: Pediatric Transplantation

  • Steven A. Webber, MBChB, MRCP · Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02904278 on ClinicalTrials.gov