Pediatric Heart Transplantation Clinical Trial
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)
Verified date | December 2019 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine: Pediatric Transplantation | Atlanta | Georgia |
United States | Boston Children's Hospital: Pediatric Transplantation | Boston | Massachusetts |
United States | Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation | Nashville | Tennessee |
United States | Columbia University Medical Center: Pediatric Transplantation | New York | New York |
United States | Montefiore Medical Center: Pediatric Transplantation | New York | New York |
United States | Children's Hospital of Philadelphia: Pediatric Transplantation | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh: Pediatric Transplantation | Pittsburgh | Pennsylvania |
United States | St. Louis Children's Hospital: Pediatric Transplantation | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Clinical Trials in Organ Transplantation in Children |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment | De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin. | Within12 Months Post-Transplantation | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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Completed |
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