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

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ClinicalTrials.gov Identifier: NCT03429335
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Heart; Surgery, Heart, Functional Disturbance as Result Behavioral: Teaching session Behavioral: Just TRAC It! Behavioral: MyHealth Passport Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2019

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!"





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429335


Contacts
Contact: Andrew S Mackie, MD 17804078361 Andrew.Mackie@albertahealthservices.ca
Contact: Angela X Han, MD (780) 952-4085 axhan@ualberta.ca

Locations
Canada, Alberta
Stollery Children's Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Andrew S Mackie, MD    (780)407-8361    Andrew.Mackie@albertahealthservices.ca   
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Andrew S Mackie, MD University of Alberta

Additional Information:
Publications:

Responsible Party: Andrew Mackie, Associate Professor of Pediatrics, University of Alberta
ClinicalTrials.gov Identifier: NCT03429335     History of Changes
Other Study ID Numbers: Just TRAC It!
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew Mackie, University of Alberta:
Transition
Adolescents
Smart phone

Additional relevant MeSH terms:
Heart Diseases
Pathologic Processes
Cardiovascular Diseases