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Patient-Reported Outcomes in Adults With Congenital Heart Disease (APPROACH-IS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02150603
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Philip Moons, Universitaire Ziekenhuizen KU Leuven

Study Description
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Brief Summary:
The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

Condition or disease
Heart Defects, Congenital

Study Design
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Study Type : Observational
Actual Enrollment : 4000 participants
Time Perspective: Cross-Sectional
Official Title: Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
Study Start Date : April 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Adults with congenital heart disease


Outcome Measures
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Primary Outcome Measures :
  1. Patient-reported health status (EuroQol-5D) [ Time Frame: Baseline ]
  2. Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale) [ Time Frame: Baseline ]
  3. Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease) [ Time Frame: Baseline ]
  4. Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale) [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Patient-reported sense of coherence (Sense of Coherence scale 13 items) [ Time Frame: Baseline ]
  2. Patient-reported illness perceptions (Brief Illness Perception Questionnaire) [ Time Frame: Baseline ]
  3. Patient-reported socio-demographic variables (e.g. age, educational level) [ Time Frame: Baseline ]
  4. Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up) [ Time Frame: Baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with congenital heart disease who are in continuing follow-up at an adult congenital heart disease center or included in a national/regional registry.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150603


Locations
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Sponsors and Collaborators
Philip Moons
Investigators
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Study Director: Philip Moons, PhD KU Leuven
Study Director: Koen Luyckx, PhD KU Leuven
Study Director: Adrienne Kovacs, PhD Peter Munk Cardiac Centre, University Health Network
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Moons, prof. dr. Philip Moons, Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT02150603    
Other Study ID Numbers: ML9231
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by Philip Moons, Universitaire Ziekenhuizen KU Leuven:
Heart defects, congenital
Patient-reported outcomes
Health status
Factors, psychosocial
Health behavior
 Quality of life
Sense of coherence
Illness perceptions
Depression
Anxiety
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities