Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology

Study Overview
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Brief Summary
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The Just TRAC It! study (Transitioning Responsibly to Adult Care using smart phone technology) is a randomized controlled trial designed to evaluate the impact of using smart phone technology in combination with the nurse led transition intervention, versus the current standard of care (nurse led transition intervention including MyHealth Passport), on preparing adolescents with chronic cardiac disease to successfully transition from pediatric to adult cardiology care. Just TRAC it! is a mobile-health intervention designed to teach youth to manage their health using existing functions on their mobile devices. We propose to conduct a nurse-led intervention that encourages adolescents to use Just TRAC it! while addressing the healthcare transition needs of 16-18 year olds.

Detailed Description
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Many adolescents and young adults living with chronic health conditions lack knowledge about their medical condition and confidence communicating with health care providers. Despite various positions statements on transition by the Canadian Pediatric Society, the American Academy of Pediatrics and the American Heart Association, there is limited evidence on the impact and effectiveness of transition interventions. Due to the convenience and accessibility of technology, adolescents embrace technology-based interventions to aid in their disease management and to improve their transition experience. However, there is a paucity of evidence-based apps in contrast to countless existing apps that are not evidence-based, which act as a barrier to physicians prescribing them. There is a pressing need for credible evidence on the effectiveness and value of health apps in improving self-management skills in adolescents. Instead of redesigning a mobile app, the Just TRAC It! encourages youth to use existing functions on their personal phones to track their health information. This information is easily retrievable when visiting health care providers and can help youth take ownership in managing their own health. This free option, using the technology already on most phones, can be used for any patient population or disease category. The use of Just TRAC It! allows youth to electronically document all medical information that would previously be printed on their MyHealth Passport, but may offer additional functionality in terms of learning to manage their health. Further investigation is warranted to evaluate the effectiveness of Just TRAC It! on improving patient knowledge, self-management skills, and transition readiness. The Stollery Children's Hospital is an international leader in pediatric to adult cardiology transition research, with two randomized clinical trials completed (CHAPTER 1 Trial, Mackie et al, Heart 2014 and CHAPTER 2 Trial, Mackie et al, BMC Cardiovascular 2016) and a 3rd in progress. The Just Trac It! Trial is an extension of our prior work. The results of the CHAPTER 1 Trial inform the current standard of care for transition interventions currently offered to all 16-18 year olds in our program who have had prior cardiac surgery, and this standard of care is the usual care (control) group for the Just Trac It! Study.

Official Title
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Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology

Conditions
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Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result

Intervention / Treatment
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* Behavioral: Teaching session
* Behavioral: Just TRAC It!
* Behavioral: MyHealth Passport


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16-18 year olds with moderate or complex CHD, or acquired heart disease requiring surgery (e.g., rheumatic heart disease, prior endocarditis, prior valve replacement, Marfan's syndrome) who are followed at the Stollery Children's Hospital. Exclusion Criteria: less than grade 6 level of reading and comprehension based on parent report heart transplantation, as this results in distinct health challenges does not have a personal mobile device, as this is required for the Just TRAC It! intervention

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized individually in permuted blocks with randomly varying sizes of 2 and 4, and allocation ratio 1:1 for intervention and control groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teaching session & Just TRAC It<br>Youth will attend a single one-on-one teaching session with a cardiology nurse (RN) the same day as their pediatric cardiology clinic visit. The RN will also explain Just TRAC It! and help the youth to enter their health information into their phone. | Behavioral: Teaching session<br>* The cardiology nurse (RN) will have an hour long one-on-one teaching session prior to their pediatric cardiology clinic visit. The RN will go over the youth's cardiac history including the chronic heart disease diagnoses, names and dates of cardiac surgical procedures and cardiac catheterizations, and current cardiac medications and doses. She will also discuss transitioning from pediatric to adult care and healthy lifestyle choices.<br>Behavioral: Just TRAC It!<br>* Just TRAC It! (Transitioning Responsibly to Adult Care) is a mobile health intervention that encourages youth to use existing functions on their personal phones to track their health information. The use of Just TRAC It! allows youth to electronically document all medical information that would previously be printed on their MyHealth Passport, but may offer additional functionality in terms of learning to manage their health.<br>|
| Active Comparator: Teaching session & MyHealth Passport<br>Youth will attend a single one-on-one teaching session with a cardiology nurse (RN) the same day as their pediatric cardiology clinic visit. The RN will help youth complete and print out a MyHealth Passport to track their medical information. | Behavioral: Teaching session<br>* The cardiology nurse (RN) will have an hour long one-on-one teaching session prior to their pediatric cardiology clinic visit. The RN will go over the youth's cardiac history including the chronic heart disease diagnoses, names and dates of cardiac surgical procedures and cardiac catheterizations, and current cardiac medications and doses. She will also discuss transitioning from pediatric to adult care and healthy lifestyle choices.<br>Behavioral: MyHealth Passport<br>* MyHealth Passport is a customized, wallet-size card that includes the youth's important medical information. The RN will help the youth create a MyHealth Passport online, and print out the card for them. The same educational intervention will be completed by cardiology nurse using a MyHealth Passport to track their medical information instead of the electronic Just TRAC It!<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transition readiness measured by the TRANSITION-Q Questionnaire score | This 14-item instrument, developed at McMaster University, is written at a grade 4.4 level and takes about 3 minutes to complete. | 3 months | 
| Change in transition readiness measured by the TRANSITION-Q Questionnaire score | This 14-item instrument, developed at McMaster University, is written at a grade 4.4 level and takes about 3 minutes to complete. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire | This questionnaire was developed for the purpose of this study to ascertain perceived helpfulness and frequency of use. | 3 months | 
| Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire | This questionnaire was developed for the purpose of this study to ascertain perceived helpfulness and frequency of use. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition, Adolescents, Smart phone