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

NCT ID: NCT03429335

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2020-12-01

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Teaching session & Just TRAC It

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.

Group Type EXPERIMENTAL

Teaching session

Intervention Type BEHAVIORAL

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.

Just TRAC It!

Intervention Type BEHAVIORAL

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.

Teaching session & MyHealth Passport

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.

Group Type ACTIVE_COMPARATOR

Teaching session

Intervention Type BEHAVIORAL

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.

MyHealth Passport

Intervention Type BEHAVIORAL

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!"

Interventions

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Teaching session

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.

Intervention Type BEHAVIORAL

Just TRAC It!

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.

Intervention Type BEHAVIORAL

MyHealth Passport

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!"

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew S Mackie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Van Deyk K, Pelgrims E, Troost E, Goossens E, Budts W, Gewillig M, Moons P. Adolescents' understanding of their congenital heart disease on transfer to adult-focused care. Am J Cardiol. 2010 Dec 15;106(12):1803-7. doi: 10.1016/j.amjcard.2010.08.020. Epub 2010 Nov 2.

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Moons P, Pinxten S, Dedroog D, Van Deyk K, Gewillig M, Hilderson D, Budts W. Expectations and experiences of adolescents with congenital heart disease on being transferred from pediatric cardiology to an adult congenital heart disease program. J Adolesc Health. 2009 Apr;44(4):316-22. doi: 10.1016/j.jadohealth.2008.11.007. Epub 2009 Feb 12.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 12456949 (View on PubMed)

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Reference Type BACKGROUND
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Related Links

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https://www.sickkids.ca/myhealthpassport/

The Hospital for Sick Children. MyHealth Passport.

Other Identifiers

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Just TRAC It!

Identifier Type: -

Identifier Source: org_study_id

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