Novel Mobile Device Application to Improve Adherence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02904278|
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : January 18, 2018
|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|
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|
|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|
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.
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
- 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).
- 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.
- 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.
- 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).
- 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).
- 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.
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
|United States, Georgia|
|Emory University School of Medicine: Pediatric Transplantation||Recruiting|
|Atlanta, Georgia, United States, 30060|
|Contact: Susie Gentry 404-785-6953 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Debra Dodd, M.D|
|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|