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

February 22, 2023 updated by: University of Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
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.
Active Comparator: 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.
Behavioral: 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.
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!"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in transition readiness measured by the TRANSITION-Q Questionnaire score
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 3 months
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
Time Frame: 6 months
This questionnaire was developed for the purpose of this study to ascertain perceived helpfulness and frequency of use.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Just TRAC It!

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease

Clinical Trials on Teaching session

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe