Congenital Heart DefectsCHAPTERNCT01286480

Congenital Heart Adolescents: Program of Transition Evaluation Research

A study testing Clinic-based Educational Intervention in people with Congenital Heart Defects, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 17 years
Conditions the study is for: Congenital Heart Defects
What is being tested?: Clinic-based Educational Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteCanada
Study dates: Jan 2011to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 15-17
Followed in the Stollery Pediatric Cardiology Clinic or the Northern Alberta Adult Congenital (NAACH) clinic
Moderate or Complex Congenital Heart Disease (as defined by the 2001 Bethesda guidelines) or Acquired Heart Disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), Marfan's syndrome or rheumatic heart disease with cardiac involvement)

Who cannot join

Developmental Delay, reading level below grade 6 based on patient or parent report

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease

The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. The results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. The results of this study may also be applicable to youth with other special health care needs.

Conditions: Congenital Heart Defects
Being tested: Clinic-based Educational Intervention
Keywords: Health Care Transition, Adolescent
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.

Clinic-based Educational InterventionBehavioural
This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.

Study groups in NCT01286480
Study group	Role	What they receive
Clinic-based Educational Intervention	Experimental	This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions. Receives: Behavioral: Clinic-based Educational Intervention
Usual Care	No intervention	Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.

What is being measured

The primary outcome is the main question the study is designed to answer.

Transition Readiness Assessment Questionnaire (TRAQ) Score
The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of "No, I do not know how" and a score of 5 assigned for responses of "Yes, I always do this when I need to." The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.
Measured: Baseline, 1 month and 6 months

Secondary outcomes (1)

MyHeart Score
Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD
Measured: Baseline, 1 month and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Dec 2013

First posted31 Jan 2011 (estimated)
Study startJan 2011
Primary completionNov 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Congenital Heart DefectsStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286480
Sponsor's protocol ID: AM-Chapter-01
Acronym: CHAPTER
Status last verified: Jun 2017
First submitted: 27 Jan 2011
Last updated: 26 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
PubMed 20040605
Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.
PubMed 11300418
Mackie 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 24842870

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
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Hummingbird ICE Study
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Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
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All Congenital Heart Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease
ClinicalTrials.gov ID: NCT01286480
Acronym / sponsor ID: CHAPTER / AM-Chapter-01
Conditions: Congenital Heart Defects
Keywords: Health Care Transition, Adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Collaborators: Women and Children's Health Research Institute, Canada, Stollery Children's Hospital Foundation
Study start: Jan 2011
Primary completion: Nov 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 26 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Clinic-based Educational Intervention	Experimental	Behavioral: Clinic-based Educational InterventionThis will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
Usual Care	No intervention	–Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.

Who may qualify

Ages: 15 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Age 15-17
Followed in the Stollery Pediatric Cardiology Clinic or the Northern Alberta Adult Congenital (NAACH) clinic
Moderate or Complex Congenital Heart Disease (as defined by the 2001 Bethesda guidelines) or Acquired Heart Disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), Marfan's syndrome or rheumatic heart disease with cardiac involvement)

Key exclusion criteria (1 listed)

Developmental Delay, reading level below grade 6 based on patient or parent report

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
Clinic-based Educational InterventionThis will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.	Behavioural	Clinic-based Educational Intervention

Primary outcome

Transition Readiness Assessment Questionnaire (TRAQ) Score
Time frame: Baseline, 1 month and 6 months
The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of "No, I do not know how" and a score of 5 assigned for responses of "Yes, I always do this when I need to." The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.

1 secondary outcome

MyHeart Score
Time frame: Baseline, 1 month and 6 months

Results and safety

Results posted to the registry on 26 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	32	27
Usual Care	34	31

Primary outcome: Transition Readiness Assessment Questionnaire (TRAQ) Score

Time frame: Baseline, 1 month and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 27	Usual Care n = 31
Baseline Self-management	2.77 (1.07)	2.95 (0.98)
Baseline Self-advocacy	3.80 (0.79)	3.92 (0.67)
1 Month Self-management	3.12 (0.75)	3.08 (0.93)
1 Month Self-advocacy	4.03 (0.52)	3.88 (0.75)
6 Month Self-management	3.59 (0.83)	3.16 (1.05)
6 Month Self-advocacy	4.38 (0.56)	4.01 (0.95)

Population analysed: The intervention involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 27 (0%)	0 of 27 (0%)	Not reported
Usual Care	0 of 31 (0%)	0 of 31 (0%)	Not reported

Limitations and caveats (from the sponsor): 1. single centre trial 2. most interventions were conducted by a single nurse 3. assessed self-management behaviours based on self-report 4. long-term follow-up and attendance in an adult cardiac clinic were not assessed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20040605Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
Background: PubMed 11300418Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.
Results publication: 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.
Individual participant dataSharing planned: No

Related trials for Congenital Heart Defects

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
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Recruiting
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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, SM 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 Clinic-based Educational Intervention in people with Congenital Heart Defects, 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 3 inclusion and 1 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 26 Jun 2017. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Transition Readiness Assessment Questionnaire (TRAQ) Score (time frame: Baseline, 1 month and 6 months). 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 NCT01286480, which also lists 3 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 26 Jun 2017.