Clinical trial NCT02904278: Novel Mobile Device Application to Improve Adherence
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Heart Transplant Recipients
Pediatric Cardiac Transplantation
Pediatric Heart Transplantation
Keywords: Mobile Application Intervention
Teen Pocket PATH® [TPP]
Adherence
Medical Management
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation in Children
First posted: 2016-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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).

Primary outcomes:
measure: Comparison of Variability in Tacrolimus Levels by Group Assignment
timeFrame: 3 months ( to 12 Months Post-Transplantation
Secondary outcomes:
measure: Count of Rejection Events within the First Year Post-Transplant by Group Assignment
timeFrame: Within 12 Months Post-Transplantation
measure: Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment
timeFrame: Within12 Months Post-Transplantation
measure: Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment
timeFrame: At Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 12 Months (Visit 4) Post-Transplantation
measure: Engagement in Self-Care Measured by TPP Activity
timeFrame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
measure: Comparison of Self-Reported Medication Adherence by Group Assignment
timeFrame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine: Pediatric Transplantation
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital: Pediatric Transplantation
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital: Pediatric Transplantation
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center: Pediatric Transplantation
state: New York
city: New York
country: United States
facility: Montefiore Medical Center: Pediatric Transplantation
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia: Pediatric Transplantation
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh: Pediatric Transplantation
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
state: Tennessee
Study officials:
affiliation: Children's Hospital of Pittsburgh: Pediatric Transplantation
name: Diana Shellmer, Ph.D.
role: STUDY_CHAIR
affiliation: Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
name: Steven A. Webber, MBChB, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.