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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02150603




Registration number
NCT02150603
Ethics application status
Date submitted
21/05/2014
Date registered
30/05/2014
Date last updated
12/03/2015

Titles & IDs
Public title
Patient-Reported Outcomes in Adults With Congenital Heart Disease
Scientific title
Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study
Secondary ID [1] 0 0
ML9231
Universal Trial Number (UTN)
Trial acronym
APPROACH-IS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Defects, Congenital 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adults with congenital heart disease -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-reported health status (EuroQol-5D)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
Timepoint [4] 0 0
Baseline
Secondary outcome [1] 0 0
Patient-reported sense of coherence (Sense of Coherence scale 13 items)
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Patient-reported illness perceptions (Brief Illness Perception Questionnaire)
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Patient-reported socio-demographic variables (e.g. age, educational level)
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)
Timepoint [4] 0 0
Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior heart transplantation
* Isolated pulmonary hypertension
* Syndromes affecting cognitive abilities

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
4000
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Private practice - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Argentina
State/province [6] 0 0
Córdoba
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Canada
State/province [8] 0 0
Edmonton
Country [9] 0 0
Canada
State/province [9] 0 0
Montreal
Country [10] 0 0
Canada
State/province [10] 0 0
Toronto
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
India
State/province [12] 0 0
Chennai
Country [13] 0 0
Italy
State/province [13] 0 0
Milan
Country [14] 0 0
Japan
State/province [14] 0 0
Chiba
Country [15] 0 0
Malta
State/province [15] 0 0
Msida
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Norway
State/province [17] 0 0
Oslo
Country [18] 0 0
Sweden
State/province [18] 0 0
Gothenburg
Country [19] 0 0
Sweden
State/province [19] 0 0
Stockholm
Country [20] 0 0
Sweden
State/province [20] 0 0
Umeå
Country [21] 0 0
Switzerland
State/province [21] 0 0
Bern
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
Philip Moons
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Moons, PhD
Address 0 0
KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02150603