Congenital Heart DiseaseNCT03429335
Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology
A study testing Teaching session, Just TRAC It! and MyHealth Passport in people with Congenital Heart Disease and Heart; Surgery, Heart, Functional Disturbance as Result, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Teaching session, Just TRAC It! and MyHealth Passport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Teaching session, Just TRAC It!, MyHealth Passport
- Keywords
- Transition, Adolescents, Smart phone
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching sessionBehavioural
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!Behavioural
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.
MyHealth PassportBehavioural
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!"
| Study group | Role | What they receive |
|---|---|---|
| Teaching session & Just TRAC It | Experimental | 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. Receives: Behavioral: Teaching session; Behavioral: Just TRAC It! |
| Teaching session & MyHealth Passport | Active comparator | 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. Receives: Behavioral: Teaching session; Behavioral: MyHealth Passport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start17 Apr 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S Mackie, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429335
- Sponsor's protocol ID
- Just TRAC It!
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell F, Biggs K, Aldiss SK, O'Neill PM, Clowes M, McDonagh J, While A, Gibson F. Transition of care for adolescents from paediatric services to adult health services. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD009794. doi: 10.1002/14651858.CD009794.pub2.
PubMed 27128768Van 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.
PubMed 21126624Kantoch MJ, Collins-Nakai RL, Medwid S, Ungstad E, Taylor DA. Adult patients' knowledge about their congenital heart disease. Can J Cardiol. 1997 Jul;13(7):641-5.
PubMed 9251576Dore A, de Guise P, Mercier LA. Transition of care to adult congenital heart centres: what do patients know about their heart condition? Can J Cardiol. 2002 Feb;18(2):141-6.
PubMed 11875583Clarizia NA, Chahal N, Manlhiot C, Kilburn J, Redington AN, McCrindle BW. Transition to adult health care for adolescents and young adults with congenital heart disease: perspectives of the patient, parent and health care provider. Can J Cardiol. 2009 Sep;25(9):e317-22. doi: 10.1016/s0828-282x(09)70145-x.
PubMed 19746251Moons 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.
PubMed 19306789Transition to adult care for youth with special health care needs. Paediatr Child Health. 2007 Nov;12(9):785-93. doi: 10.1093/pch/12.9.785. No abstract available.
PubMed 19030468American Academy of Pediatrics; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine. A consensus statement on health care transitions for young adults with special health care needs. Pediatrics. 2002 Dec;110(6 Pt 2):1304-6.
PubMed 12456949Sable C, Foster E, Uzark K, Bjornsen K, Canobbio MM, Connolly HM, Graham TP, Gurvitz MZ, Kovacs A, Meadows AK, Reid GJ, Reiss JG, Rosenbaum KN, Sagerman PJ, Saidi A, Schonberg R, Shah S, Tong E, Williams RG; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Best practices in managing transition to adulthood for adolescents with congenital heart disease: the transition process and medical and psychosocial issues: a scientific statement from the American Heart Association. Circulation. 2011 Apr 5;123(13):1454-85. doi: 10.1161/CIR.0b013e3182107c56. Epub 2011 Feb 28. No abstract available.
PubMed 21357825Mackie AS, Islam S, Magill-Evans J, Rankin KN, Robert C, Schuh M, Nicholas D, Vonder Muhll I, McCrindle BW, Yasui Y, Rempel GR. Healthcare transition for youth with heart disease: a clinical trial. Heart. 2014 Jul;100(14):1113-8. doi: 10.1136/heartjnl-2014-305748. Epub 2014 May 19.
PubMed 24842870Huang JS, Gottschalk M, Pian M, Dillon L, Barajas D, Bartholomew LK. Transition to adult care: systematic assessment of adolescents with chronic illnesses and their medical teams. J Pediatr. 2011 Dec;159(6):994-8.e2. doi: 10.1016/j.jpeds.2011.05.038. Epub 2011 Jul 23.
PubMed 21784450Trawley S, Browne JL, Hagger VL, Hendrieckx C, Holmes-Truscott E, Pouwer F, Skinner TC, Speight J. The Use of Mobile Applications Among Adolescents with Type 1 Diabetes: Results from Diabetes MILES Youth-Australia. Diabetes Technol Ther. 2016 Dec;18(12):813-819. doi: 10.1089/dia.2016.0233. Epub 2016 Oct 27.
PubMed 27788032Geryk LL, Roberts CA, Sage AJ, Coyne-Beasley T, Sleath BL, Carpenter DM. Parent and Clinician Preferences for an Asthma App to Promote Adolescent Self-Management: A Formative Study. JMIR Res Protoc. 2016 Dec 6;5(4):e229. doi: 10.2196/resprot.5932.
PubMed 27923777Crosby LE, Ware RE, Goldstein A, Walton A, Joffe NE, Vogel C, Britto MT. Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. Pediatr Blood Cancer. 2017 Jan;64(1):139-145. doi: 10.1002/pbc.26177. Epub 2016 Aug 30.
PubMed 27574031Majeed-Ariss R, Baildam E, Campbell M, Chieng A, Fallon D, Hall A, McDonagh JE, Stones SR, Thomson W, Swallow V. Apps and Adolescents: A Systematic Review of Adolescents' Use of Mobile Phone and Tablet Apps That Support Personal Management of Their Chronic or Long-Term Physical Conditions. J Med Internet Res. 2015 Dec 23;17(12):e287. doi: 10.2196/jmir.5043.
PubMed 26701961
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology
- ClinicalTrials.gov ID
- NCT03429335
- Acronym / sponsor ID
- Just TRAC It!
- Keywords
- Transition, Adolescents, Smart phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Teaching session & Just TRAC It | Experimental | Behavioral: Teaching session, Behavioral: 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. |
| Teaching session & MyHealth Passport | Active comparator | Behavioral: Teaching session, Behavioral: MyHealth PassportYouth 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. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teaching sessionThe 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. | Behavioural | Teaching session & Just TRAC It, Teaching session & MyHealth Passport |
| 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. | Behavioural | Teaching session & Just TRAC It |
| MyHealth PassportMyHealth 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!" | Behavioural | Teaching session & MyHealth Passport |
Primary outcome
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.
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.
2 secondary outcomes
Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire
Time frame: 3 months
Frequency of use and perceived helpfulness of intervention measured by Just TRAC It! Questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27128768Campbell F, Biggs K, Aldiss SK, O'Neill PM, Clowes M, McDonagh J, While A, Gibson F. Transition of care for adolescents from paediatric services to adult health services. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD009794. doi: 10.1002/14651858.CD009794.pub2.
- Background: PubMed 21126624Van 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.
- Background: PubMed 9251576Kantoch MJ, Collins-Nakai RL, Medwid S, Ungstad E, Taylor DA. Adult patients' knowledge about their congenital heart disease. Can J Cardiol. 1997 Jul;13(7):641-5.
- Background: PubMed 11875583Dore A, de Guise P, Mercier LA. Transition of care to adult congenital heart centres: what do patients know about their heart condition? Can J Cardiol. 2002 Feb;18(2):141-6.
- Background: PubMed 19746251Clarizia NA, Chahal N, Manlhiot C, Kilburn J, Redington AN, McCrindle BW. Transition to adult health care for adolescents and young adults with congenital heart disease: perspectives of the patient, parent and health care provider. Can J Cardiol. 2009 Sep;25(9):e317-22. doi: 10.1016/s0828-282x(09)70145-x.
- Background: PubMed 19306789Moons 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.
- Background: PubMed 19030468Transition to adult care for youth with special health care needs. Paediatr Child Health. 2007 Nov;12(9):785-93. doi: 10.1093/pch/12.9.785. No abstract available.
- Background: PubMed 12456949American Academy of Pediatrics; American Academy of Family Physicians; American College of Physicians-American Society of Internal Medicine. A consensus statement on health care transitions for young adults with special health care needs. Pediatrics. 2002 Dec;110(6 Pt 2):1304-6.
- Background: PubMed 21357825Sable C, Foster E, Uzark K, Bjornsen K, Canobbio MM, Connolly HM, Graham TP, Gurvitz MZ, Kovacs A, Meadows AK, Reid GJ, Reiss JG, Rosenbaum KN, Sagerman PJ, Saidi A, Schonberg R, Shah S, Tong E, Williams RG; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Best practices in managing transition to adulthood for adolescents with congenital heart disease: the transition process and medical and psychosocial issues: a scientific statement from the American Heart Association. Circulation. 2011 Apr 5;123(13):1454-85. doi: 10.1161/CIR.0b013e3182107c56. Epub 2011 Feb 28. No abstract available.
- Background: PubMed 24842870Mackie AS, Islam S, Magill-Evans J, Rankin KN, Robert C, Schuh M, Nicholas D, Vonder Muhll I, McCrindle BW, Yasui Y, Rempel GR. Healthcare transition for youth with heart disease: a clinical trial. Heart. 2014 Jul;100(14):1113-8. doi: 10.1136/heartjnl-2014-305748. Epub 2014 May 19.
- Background: PubMed 21784450Huang JS, Gottschalk M, Pian M, Dillon L, Barajas D, Bartholomew LK. Transition to adult care: systematic assessment of adolescents with chronic illnesses and their medical teams. J Pediatr. 2011 Dec;159(6):994-8.e2. doi: 10.1016/j.jpeds.2011.05.038. Epub 2011 Jul 23.
- Background: PubMed 27788032Trawley S, Browne JL, Hagger VL, Hendrieckx C, Holmes-Truscott E, Pouwer F, Skinner TC, Speight J. The Use of Mobile Applications Among Adolescents with Type 1 Diabetes: Results from Diabetes MILES Youth-Australia. Diabetes Technol Ther. 2016 Dec;18(12):813-819. doi: 10.1089/dia.2016.0233. Epub 2016 Oct 27.
- The Hospital for Sick Children. MyHealth Passport.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew S Mackie, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching session, Just TRAC It! and MyHealth Passport in people with Congenital Heart Disease and Heart; Surgery, Heart, Functional Disturbance as Result, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transition readiness measured by the TRANSITION-Q Questionnaire score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429335, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.