The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date May 21, 2014
First Posted Date May 30, 2014
Last Update Posted Date March 12, 2015
Study Start Date April 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2014)
  • Patient-reported health status (EuroQol-5D) [ Time Frame: Baseline ]
  • Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale) [ Time Frame: Baseline ]
  • Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease) [ Time Frame: Baseline ]
  • Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale) [ Time Frame: Baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2014)
  • Patient-reported sense of coherence (Sense of Coherence scale 13 items) [ Time Frame: Baseline ]
  • Patient-reported illness perceptions (Brief Illness Perception Questionnaire) [ Time Frame: Baseline ]
  • Patient-reported socio-demographic variables (e.g. age, educational level) [ Time Frame: Baseline ]
  • Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up) [ Time Frame: Baseline ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient-Reported Outcomes in Adults With Congenital Heart Disease
Official Title Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
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).
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Heart Defects, Congenital
Intervention Not Provided
Study Groups/Cohorts Adults with congenital heart disease
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2015)		 4000
Original Estimated Enrollment
 (submitted: May 27, 2014)		 5000
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Australia,   Belgium,   Canada,   France,   India,   Italy,   Japan,   Malta,   Netherlands,   Norway,   Sweden,   Switzerland,   Taiwan,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number NCT02150603
Other Study ID Numbers ML9231
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Philip Moons, Universitaire Ziekenhuizen KU Leuven
Original Responsible Party Same as current
Current Study Sponsor Philip Moons
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
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
PRS Account Universitaire Ziekenhuizen KU Leuven
Verification Date March 2015