Congenital Heart DiseaseNCT01723332
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
A study testing Educational and Self management in people with Congenital Heart Disease, run by University of Alberta at 2 sites in Canada.
Trial summary
Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Educational and Self management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2012to 1 Dec 2016
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 16 and 17 year olds with moderate or complex CHD
Who cannot join
- Significant developmental delay
- Previous heart transplantation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
About this study
Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.
This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.
Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.
- Conditions
- Congenital Heart Disease
- Being tested
- Educational, Self management
- Keywords
- Transition from pediatric to adult clinical care
- 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.
EducationalBehavioural
The first interaction will happen at study enrolment and will be educational in nature.
Following the session, the nurse will follow up with the participant to discuss any questions.
Self managementBehavioural
The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.
Following the session, the nurse will follow up with the participant to discuss any questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clinical based educational and self management intervention. Receives: Behavioral: Educational; Behavioral: Self management |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess time to first ACHD clinic appointment.
Measured: 12 - 24 months post enrolment
Secondary outcomes (2)
Change in adolescent knowledge of their condition.
Measured: 6 - 18 months post enrolment
Change in adolescent's self-management and self-advocacy skills/
Measured: 6 - 18 months post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Andrew Mackie, University of Alberta
- Investigators
- Andrew S Mackie, MD, SM, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723332
- Sponsor's protocol ID
- CHAPTER II
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Yaskina M, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, McCrindle BW. Transition Intervention for Adolescents With Congenital Heart Disease. J Am Coll Cardiol. 2018 Apr 24;71(16):1768-1777. doi: 10.1016/j.jacc.2018.02.043.
PubMed 29673467Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, McCrindle BW. A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study. BMC Cardiovasc Disord. 2016 Jun 6;16:127. doi: 10.1186/s12872-016-0307-2.
PubMed 27266868
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
- ClinicalTrials.gov ID
- NCT01723332
- Acronym / sponsor ID
- CHAPTER II
- Conditions
- Congenital Heart Disease
- Keywords
- Transition from pediatric to adult clinical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Nov 2012
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 7 Nov 2012 (estimated)
- 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.
Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.
This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.
Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational, Behavioral: Self managementClinical based educational and self management 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. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 16 and 17 year olds with moderate or complex CHD
Key exclusion criteria (2 listed)
- Significant developmental delay
- Previous heart transplantation
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 |
|---|---|---|
| EducationalThe first interaction will happen at study enrolment and will be educational in nature. Following the session, the nurse will follow up with the participant to discuss any questions. | Behavioural | Intervention |
| Self managementThe second interaction will take place 2 months after enrollment and will focus on self management and communication skills. Following the session, the nurse will follow up with the participant to discuss any questions. | Behavioural | Intervention |
Primary outcome
Excess time to first ACHD clinic appointment.
Time frame: 12 - 24 months post enrolment
2 secondary outcomes
Change in adolescent knowledge of their condition.
Time frame: 6 - 18 months post enrolment
Change in adolescent's self-management and self-advocacy skills/
Time frame: 6 - 18 months post enrolment
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 6 Nov 2017.
- Derived from this study: PubMed 29673467Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Yaskina M, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, McCrindle BW. Transition Intervention for Adolescents With Congenital Heart Disease. J Am Coll Cardiol. 2018 Apr 24;71(16):1768-1777. doi: 10.1016/j.jacc.2018.02.043.
- Derived from this study: PubMed 27266868Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, McCrindle BW. A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study. BMC Cardiovasc Disord. 2016 Jun 6;16:127. doi: 10.1186/s12872-016-0307-2.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and Self management in people with Congenital Heart Disease, run by University of Alberta at 2 sites 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 2 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Excess time to first ACHD clinic appointment. (time frame: 12 - 24 months post enrolment). 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 NCT01723332, which also lists 2 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 6 Nov 2017.