Novel Mobile Device Application to Improve Adherence

December 3, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30060
        • Emory University School of Medicine: Pediatric Transplantation
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital: Pediatric Transplantation
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital: Pediatric Transplantation
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center: Pediatric Transplantation
      • New York, New York, United States, 10467
        • Montefiore Medical Center: Pediatric Transplantation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia: Pediatric Transplantation
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh: Pediatric Transplantation
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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 Names:
  • Mobile app
  • TPP mobile app
  • Mobile health application
  • cell phone app
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.
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.
Other Names:
  • Post Heart Transplant Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Variability in Tacrolimus Levels by Group Assignment
Time Frame: 3 months ( to 12 Months Post-Transplantation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of Rejection Events within the First Year Post-Transplant by Group Assignment
Time Frame: Within 12 Months Post-Transplantation
Rejection events will include acute cellular, mixed, and clinical rejection.
Within 12 Months Post-Transplantation
Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment
Time Frame: Within12 Months Post-Transplantation
De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin.
Within12 Months Post-Transplantation
Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment
Time Frame: At Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 12 Months (Visit 4) Post-Transplantation
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
Engagement in Self-Care Measured by TPP Activity
Time Frame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
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
Comparison of Self-Reported Medication Adherence by Group Assignment
Time Frame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Clinical Trials in Organ Transplantation in Children

Investigators

  • Study Chair: Diana Shellmer, Ph.D., Children's Hospital of Pittsburgh: Pediatric Transplantation
  • Principal Investigator: Steven A. Webber, MBChB, MRCP, Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT CTOTC-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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