- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286480
Congenital Heart Adolescents: Program of Transition Evaluation Research (CHAPTER)
June 23, 2017 updated by: Andrew Mackie, University of Alberta
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- Stollery Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Developmental Delay, reading level below grade 6 based on patient or parent report
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clinic-based Educational Intervention
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.
|
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.
|
No Intervention: Usual Care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 1 month and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MyHeart Score
Time Frame: Baseline, 1 month and 6 months
|
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
|
Baseline, 1 month and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew S Mackie, MD, SM, University of Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 27, 2011
First Submitted That Met QC Criteria
January 27, 2011
First Posted (Estimate)
January 31, 2011
Study Record Updates
Last Update Posted (Actual)
June 26, 2017
Last Update Submitted That Met QC Criteria
June 23, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AM-Chapter-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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