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Novel Mobile Device Application to Improve Adherence

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ClinicalTrials.gov Identifier: NCT02904278
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Pediatric Heart Transplant Recipients Pediatric Cardiac Transplantation Pediatric Heart Transplantation Other: Teen Pocket PATH® Mobile Application Other: Control Group: Standard of Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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)
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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:
  • TPP mobile app
  • Mobile health application
  • Mobile app
  • cell phone app

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 Name: Post Heart Transplant Standard of Care




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904278


Locations
United States, Georgia
Emory University School of Medicine: Pediatric Transplantation Recruiting
Atlanta, Georgia, United States, 30060
Contact: Susie Gentry    404-785-6953    susie.gentry@choa.org   
Principal Investigator: William Mahle, M.D.         
United States, Massachusetts
Boston Children's Hospital: Pediatric Transplantation Recruiting
Boston, Massachusetts, United States, 02115
Contact: Meaghan Molloy    617-355-4213    Meaghan.Molloy@cardio.chboston.org   
Principal Investigator: Tajinder P. Singh, M.D         
United States, Missouri
St. Louis Children's Hospital: Pediatric Transplantation Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Teresa Roberson    314-286-2404    roberson_t@kids.wustl.edu   
Principal Investigator: Charles Canter, M.D.         
United States, New York
Columbia University Medical Center: Pediatric Transplantation Recruiting
New York, New York, United States, 10032
Contact: Warren Zuckerman    212-305-6575    wz2116@columbia.edu   
Principal Investigator: Linda Addonizio, M.D.         
Montefiore Medical Center: Pediatric Transplantation Recruiting
New York, New York, United States, 10467
Contact: Kimberly Beddows    718-741-2260    kbeddows@montefiore.org   
Principal Investigator: Daphne Hsu, M.D.         
United States, Pennsylvania
Children's Hospital of Philadelphia: Pediatric Transplantation Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rylie Pietrowicz    267-426-3159    pietrowicr@email.chop.edu   
Principal Investigator: Robert Shaddy, M.D.         
Children's Hospital of Pittsburgh: Pediatric Transplantation Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Margaret Abraham    412-692-6061    abrahamm2@upmc.edu   
Principal Investigator: Brian Feingold, M.D., MS         
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation Recruiting
Nashville, Tennessee, United States, 37232
Contact: Darlene Fountain    615-343-6503    darlene.fountain@vanderbilt.edu   
Principal Investigator: Debra Dodd, M.D         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02904278     History of Changes
Other Study ID Numbers: DAIT CTOTC-10
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Mobile Application Intervention
Teen Pocket PATH® [TPP]
Adherence
Medical Management