Randomized, Controlled Trial of a Novel Mobile Device Application to Improve Adherence in Children Greater Than 11 Years of Age After Cardiac Transplantation (CTOTC-10)

Status: Completed
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 17
Healthy Volunteers: No
View:

• Enrolled (consented) prior to hospital discharge from heart transplantation or within one month after discharge, but not later than 3 months post-transplantation;

• English as primary language or fluent in English; and

• Informed consent and assent obtained.

Locations
United States
Georgia
Emory University School of Medicine: Pediatric Transplantation
Atlanta
Massachusetts
Boston Children's Hospital: Pediatric Transplantation
Boston
Missouri
St. Louis Children's Hospital: Pediatric Transplantation
Saint Louis
New York
Columbia University Medical Center: Pediatric Transplantation
New York
Montefiore Medical Center: Pediatric Transplantation
New York
Pennsylvania
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia
Children's Hospital of Pittsburgh: Pediatric Transplantation
Pittsburgh
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
Nashville
Time Frame
Start Date: August 10, 2017
Completion Date: November 1, 2019
Participants
Target number of participants: 26
Treatments
Experimental: Teen Pocket PATH® Mobile Application
Participants in this group will receive the mobile application for improving adherence to their post-transplant medications, along with standard post-transplant care, in accordance with the CTOTC-10 Cardiac Consortium Clinical Care Guidelines.~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. Additionally, the mobile app. will inform the investigators, by way of automated text messaging, of treatment adherence.~Duration of participation: up to 12 months post heart transplantation.
Other: Control Group: Standard of Care
Participants in the control group will receive standard post-transplant care, in accordance with the CTOTC-10 Cardiac Consortium Clinical Care Guidelines.~Duration of participation: up to 12 months post heart transplantation.
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Trials in Organ Transplantation in Children
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials