Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02904278
Other study ID # DAIT CTOTC-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2017
Est. completion date November 1, 2019

Study information

Verified date December 2019
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a multi-center, randomized, open label clinical trial of a novel mobile application. The intervention in this randomized controlled trial is the provision of a novel mobile health application (Teen Pocket PATH® [TPP]). Participants will include heart recipients 11-17 years of age transplanted at one of the listed study sites (refer to Contacts and Locations Section of this ClinicalTrials.gov record).

It is important that heart transplant recipients take their prescribed heart transplant medication. One of the challenges for adolescent (children ages 11 to 17) heart transplant recipients is being able to follow their medication dosing schedule consistently. The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medications. The investigators want to find out if regular use of 'an app' on the participant's cell phone, called the Teen Pocket PATH® (TPP), can help adolescent heart transplant recipients 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 evaluate whether how one takes 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 recipient's new heart.

The TPP app provides reminders to the participant and their parent/guardian, includes a list of their medications, and maintains a log to help track medication taking. The parent(s) will receive a text message when their participating child enters into the TPP app that s/he has taken his/her medication. The parent(s) will also be notified via text if their participating adolescent child does not enter information into the TPP app regarding their medication adherence and related timing information. The information collected on the TTP app will be available to the study investigators.

Eligible participants will be randomly selected (randomized) to be in one of two groups: this means that each participant will have an equal but random chance of being assigned to:

- the Experimental Group - participants will receive standard of care and use the TPP app to monitor how they take their medication or

- the Control Group - participants will receive standard of care and will not not receive the TPP app.

Both groups will have the same number of scheduled research visits and will receive the usual treatment and medication provided by their doctor for their heart transplant. Research visits will coincide with your routine clinic visits.

The study will not change the care that participants receive prior to, during or after transplantation. The study will collect information about participants, their medication dosing schedule, and their medical condition and care. In addition, the investigators will collect some blood at certain times for research. This blood will be used to measure antibodies in the blood.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 11 Years to 17 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University School of Medicine: Pediatric Transplantation Atlanta Georgia
United States Boston Children's Hospital: Pediatric Transplantation Boston Massachusetts
United States Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation Nashville Tennessee
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 St. Louis Children's Hospital: Pediatric Transplantation Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation in Children

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Variability in Tacrolimus Levels by Group Assignment Variability in tacrolimus levels (standard deviation of post discharge first year outpatient tacrolimus levels commencing at 3 months post-transplantation). 3 months ( to 12 Months Post-Transplantation
Secondary Count of Rejection Events within the First Year Post-Transplant by Group Assignment Rejection events will include acute cellular, mixed, and clinical rejection. Within 12 Months Post-Transplantation
Secondary Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin. Within12 Months Post-Transplantation
Secondary Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment Engagement in self-care as measured by self-report using the Medication Adherence Measure (MAM). At Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 12 Months (Visit 4) Post-Transplantation
Secondary Engagement in Self-Care Measured by TPP Activity Engagement in self-care during the first year after heart transplantation as measured by the mobile app, Teen Pocket PATH® (TPP). Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Secondary Comparison of Self-Reported Medication Adherence by Group Assignment Self-reported medication adherence assessed using the medication module of the Medication Adherence Measure (MAM).
The MAM will be applied at each clinic visit unless within 7 days of prior visit. Scores for all surveys will be averaged over the course of follow-up.
Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
See also
  Status Clinical Trial Phase
Completed NCT02752789 - Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function
Active, not recruiting NCT03386539 - Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score Phase 3
Completed NCT01005316 - Allo-Antibodies in Pediatric Heart Transplantation N/A