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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation in Children | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine: Pediatric Transplantation | Atlanta | Georgia | 30060 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. |
| Label | URL |
|---|---|
| The National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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| 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. |
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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 | 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 | 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 | 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 |
| Boston Children's Hospital: Pediatric Transplantation |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| St. Louis Children's Hospital: Pediatric Transplantation | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center: Pediatric Transplantation | New York | New York | 10032 | United States |
| Montefiore Medical Center: Pediatric Transplantation | New York | New York | 10467 | United States |
| Children's Hospital of Philadelphia: Pediatric Transplantation | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh: Pediatric Transplantation | Pittsburgh | Pennsylvania | 15224 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation | Nashville | Tennessee | 37232 | United States |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| The Clinical Trials in Organ Transplantation in Children (CTOT-C) | View source |