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.
Brief Title
Novel Mobile Device Application to Improve Adherence
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Pediatric Heart Transplant Recipients
Pediatric Cardiac Transplantation
Pediatric Heart Transplantation
Eligibility 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).
* 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).
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Mobile Application Intervention
Teen Pocket PATH® [TPP]
Adherence
Medical Management
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
11 Years
NCT Id
NCT02904278
Org Class
Nih
Org Full Name
National Institute of Allergy and Infectious Diseases (NIAID)
Org Study Id
DAIT CTOTC-10
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
Variability in tacrolimus levels (standard deviation of post discharge first year outpatient tacrolimus levels commencing at 3 months post-transplantation).
Outcome Measure
Comparison of Variability in Tacrolimus Levels by Group Assignment
Outcome Time Frame
3 months ( to 12 Months Post-Transplantation
Secondary Outcomes
Outcome Description
Rejection events will include acute cellular, mixed, and clinical rejection.
Outcome Time Frame
Within 12 Months Post-Transplantation
Outcome Measure
Count of Rejection Events within the First Year Post-Transplant by Group Assignment
Outcome Description
De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin.
Outcome Time Frame
Within12 Months Post-Transplantation
Outcome Measure
Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment
Outcome Description
Engagement in self-care as measured by self-report using the Medication Adherence Measure (MAM).
Outcome Time Frame
At Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 12 Months (Visit 4) Post-Transplantation
Outcome Measure
Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment
Outcome Description
Engagement in self-care during the first year after heart transplantation as measured by the mobile app, Teen Pocket PATH® (TPP).
Outcome Time Frame
Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Outcome Measure
Engagement in Self-Care Measured by TPP Activity
Outcome Description
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.
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.
Outcome Time Frame
Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Outcome Measure
Comparison of Self-Reported Medication Adherence by Group Assignment
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
11
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daphne Hsu
Investigator Email
dhsu@montefiore.org
Investigator Phone
718-741-2538