Novel Mobile Device Application to Improve Adherence

Completed · Not applicable

Conditions studied: Pediatric Heart Transplant Recipients, Pediatric Cardiac Transplantation, Pediatric Heart Transplantation

In brief

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.

Key facts

Study ID

NCT02904278

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

26

Starts

2017-08-10

Expected to finish

2019-11-01

Last updated by the study team

2019-12-04

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Positive donor-specific cytotoxicity requiring different immunosuppressive regimen from standard care;
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
• Re-transplant or multi-organ transplant recipient;
• Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete at least one year of follow-up; or
• Current participation in other research studies that would, or might, interfere with the scientific integrity or safety of current study (e.g. by interference with immunosuppression management guidelines and study end-points).

Where it is running

• Emory University School of Medicine: Pediatric Transplantation — Atlanta, Georgia, United States
• Boston Children's Hospital: Pediatric Transplantation — Boston, Massachusetts, United States
• St. Louis Children's Hospital: Pediatric Transplantation — St Louis, Missouri, United States
• Columbia University Medical Center: Pediatric Transplantation — New York, New York, United States
• Montefiore Medical Center: Pediatric Transplantation — New York, New York, United States
• Children's Hospital of Philadelphia: Pediatric Transplantation — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh: Pediatric Transplantation — Pittsburgh, Pennsylvania, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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