Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 March 2015 |
Main ID: |
NCT02150603 |
Date of registration:
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21/05/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Patient-Reported Outcomes in Adults With Congenital Heart Disease
APPROACH-IS |
Scientific title:
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Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study |
Date of first enrolment:
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April 2013 |
Target sample size:
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4000 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02150603 |
Study type:
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Observational |
Study design:
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Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Canada
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France
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India
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Italy
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Japan
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Malta
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Netherlands
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Norway
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Sweden
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Switzerland
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Adrienne Kovacs, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Peter Munk Cardiac Centre, University Health Network |
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Name:
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Philip Moons, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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KU Leuven |
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Name:
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Koen Luyckx, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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KU Leuven |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with congenital heart disease, defined as: a gross structural abnormality
of the heart or intra-thoracic great vessels that is actually or potentially of
functional significance (including mild, moderate, and severe heart defects)
- 18 years of age or older
- Diagnosed under the age of ten, i.e. before adolescence
- Continuing follow-up at an adult congenital heart disease center or included in a
national/regional registry
- Physical, cognitive, and language abilities to complete self-report questionnaires
Exclusion Criteria:
- Prior heart transplantation
- Isolated pulmonary hypertension
- Syndromes affecting cognitive abilities
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Defects, Congenital
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Primary Outcome(s)
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Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
[Time Frame: Baseline]
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Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
[Time Frame: Baseline]
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Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
[Time Frame: Baseline]
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Patient-reported health status (EuroQol-5D)
[Time Frame: Baseline]
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Secondary Outcome(s)
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Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)
[Time Frame: Baseline]
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Patient-reported sense of coherence (Sense of Coherence scale 13 items)
[Time Frame: Baseline]
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Patient-reported illness perceptions (Brief Illness Perception Questionnaire)
[Time Frame: Baseline]
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Patient-reported socio-demographic variables (e.g. age, educational level)
[Time Frame: Baseline]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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