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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Teaching session
Just TRAC It!
MyHealth Passport
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Transition, Adolescents, Smart phone

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stollery Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teaching session & Just TRAC It

Teaching session & MyHealth Passport

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 5, 2018
Last Updated
February 22, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03429335
Brief Title
Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology
Official Title
Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result
Keywords
Transition, Adolescents, Smart phone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teaching session & Just TRAC It
Arm Type
Experimental
Arm Description
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.
Arm Title
Teaching session & MyHealth Passport
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teaching session
Intervention Description
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
Intervention Name(s)
Just TRAC It!
Intervention Description
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
Intervention Name(s)
MyHealth Passport
Intervention Description
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!"
Primary Outcome Measure Information:
Title
Change in transition readiness measured by the TRANSITION-Q Questionnaire score
Description
This 14-item instrument, developed at McMaster University, is written at a grade 4.4 level and takes about 3 minutes to complete.
Time Frame
3 months
Title
Change in transition readiness measured by the TRANSITION-Q Questionnaire score
Description
This 14-item instrument, developed at McMaster University, is written at a grade 4.4 level and takes about 3 minutes to complete.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire
Description
This questionnaire was developed for the purpose of this study to ascertain perceived helpfulness and frequency of use.
Time Frame
3 months
Title
Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire
Description
This questionnaire was developed for the purpose of this study to ascertain perceived helpfulness and frequency of use.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S Mackie, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.bcchildrens.ca/our-services/support-services/transition-to-adult-care/just-trac-it
Description
British Columbia Children's Hospital. Just TRAC it!
URL
https://www.sickkids.ca/myhealthpassport/
Description
The Hospital for Sick Children. MyHealth Passport.

Learn more about this trial

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

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