Pediatric Heart Transplant RecipientsNCT02904278
Novel Mobile Device Application to Improve Adherence
A study testing Teen Pocket PATH® Mobile Application in people with Pediatric Heart Transplant Recipients and Pediatric Cardiac Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Pediatric Heart Transplant Recipients, Pediatric Cardiac Transplantation, Pediatric Heart Transplantation
- What is being tested?
- Teen Pocket PATH® Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Aug 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University School of Medicine: Pediatric Transplantation
Atlanta, Georgia, 30060
Boston Children's Hospital: Pediatric Transplantation
Boston, Massachusetts, 02115
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
Nashville, Tennessee, 37232
Columbia University Medical Center: Pediatric Transplantation
New York, New York, 10032
Montefiore Medical Center: Pediatric Transplantation
New York, New York, 10467
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh: Pediatric Transplantation
Pittsburgh, Pennsylvania, 15224
St. Louis Children's Hospital: Pediatric Transplantation
St Louis, Missouri, 63110
About this study
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)
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.
Read the 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.
- Conditions
- Pediatric Heart Transplant Recipients, Pediatric Cardiac Transplantation, Pediatric Heart Transplantation
- Being tested
- Teen Pocket PATH® Mobile Application, Control Group: Standard of Care
- Keywords
- Mobile Application Intervention, Teen Pocket PATH® [TPP], Adherence, Medical Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Pocket PATH® Mobile ApplicationOther
Also called TPP mobile app, Mobile health application, Mobile app, cell phone app
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 CareOther
Also called Post Heart Transplant Standard of Care
Adolescents and parents/guardians assigned to the Standard Care Condition will receive standard clinical care per standard site procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Teen Pocket PATH® Mobile Application |
| 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. Receives: Other: Control Group: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months ( to 12 Months Post-Transplantation
Secondary outcomes (5)
Count of Rejection Events within the First Year Post-Transplant by Group Assignment
Rejection events will include acute cellular, mixed, and clinical rejection.
Measured: 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
De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start10 Aug 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Heart Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Responsible party
- Sponsor
- Investigators
- Diana Shellmer, Ph.D., Study chair, Children's Hospital of Pittsburgh: Pediatric TransplantationSteven A. Webber, MBChB, MRCP, Principal investigator, Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904278
- Sponsor's protocol ID
- DAIT CTOTC-10
- Status last verified
- Dec 2019
- First submitted
- 13 Sep 2016
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02904278
- Acronym / sponsor ID
- DAIT CTOTC-10
- Conditions
- Pediatric Heart Transplant Recipients, Pediatric Cardiac Transplantation, Pediatric Heart Transplantation
- Keywords
- Mobile Application Intervention, Teen Pocket PATH® [TPP], Adherence, Medical Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Pocket PATH® Mobile Application | Experimental | Other: Teen Pocket PATH® Mobile ApplicationParticipants 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. |
| Control Group: Standard of Care | Other | Other: Control Group: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen Pocket PATH® Mobile ApplicationAlso: TPP mobile app, Mobile health application, Mobile app, cell phone appParticipants 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. | Other | Teen Pocket PATH® Mobile Application |
| Control Group: Standard of CareAlso: Post Heart Transplant Standard of CareAdolescents and parents/guardians assigned to the Standard Care Condition will receive standard clinical care per standard site procedures. | Other | Control Group: Standard of Care |
Primary outcome
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).
5 secondary outcomes
Count of Rejection Events within the First Year Post-Transplant by Group Assignment
Time frame: 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
Time frame: Within12 Months Post-Transplantation
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 Measured by TPP Activity
Time frame: 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
Time frame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Derived from this study: PubMed 36094829Mellon 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.
- The National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- The Clinical Trials in Organ Transplantation in Children (CTOT-C)Link provided by the sponsor.
Related trials for Pediatric Heart Transplant Recipients
RecruitingObservational study
Non-invasive Prediction of EArly Cardiac rEjection
Heart Transplant, Pediatric Heart Transplant
Recruiting
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
Heart Transplant Rejection, Immune Suppression
Recruiting
HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
Pediatric ALL, Transplant; Failure, Heart
RecruitingObservational study
Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients
Pediatric Heart Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Shellmer, Ph.D. study chair
Children's Hospital of Pittsburgh: Pediatric Transplantation
Steven A. Webber, MBChB, MRCP principal investigator
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Pocket PATH® Mobile Application in people with Pediatric Heart Transplant Recipients and Pediatric Cardiac Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Variability in Tacrolimus Levels by Group Assignment (time frame: 3 months ( to 12 Months Post-Transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.