Novel Mobile Device Application to Improve Adherence

NCT02904278 | Completed DMC

• 1 other identifier: DAIT CTOTC-10
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Mobile Application Intervention; Teen Pocket PATH® [TPP]; Adherence; Medical Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Count of Rejection Events within the First Year Post-Transplant by Group Assignment

  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

  Within12 Months Post-Transplantation

• Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment

  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

  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

  Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation

Study Arms (2)

Teen Pocket PATH® Mobile Application

EXPERIMENTAL

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

Control Group: Standard of Care

OTHER

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

Interventions

Teen Pocket PATH® Mobile Application OTHER

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.

Also known as: TPP mobile app, Mobile health application, Mobile app, cell phone app

Teen Pocket PATH® Mobile Application

Control Group: Standard of Care OTHER

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

Also known as: Post Heart Transplant Standard of Care

Control Group: Standard of Care

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Clinical Trials in Organ Transplantation in Children: collaborator

Study Sites (8)

Emory University School of Medicine: Pediatric Transplantation

Atlanta, Georgia, 30060, United States

Location

Boston Children's Hospital: Pediatric Transplantation

Boston, Massachusetts, 02115, United States

Location

St. Louis Children's Hospital: Pediatric Transplantation

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center: Pediatric Transplantation

New York, New York, 10032, United States

Location

Montefiore Medical Center: Pediatric Transplantation

New York, New York, 10467, United States

Location

Children's Hospital of Philadelphia: Pediatric Transplantation

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh: Pediatric Transplantation

Pittsburgh, Pennsylvania, 15224, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

  PMID: 36094829 DERIVED

Related Links

• The National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• The Clinical Trials in Organ Transplantation in Children (CTOT-C)

Study Officials

• Diana Shellmer, Ph.D.

  Children's Hospital of Pittsburgh: Pediatric Transplantation

  STUDY CHAIR

• Steven A. Webber, MBChB, MRCP

  Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: August 10, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

US (8)