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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Cross-sectional
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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02150603
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02150603