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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04902768




Registration number
NCT04902768
Ethics application status
Date submitted
20/05/2021
Date registered
26/05/2021

Titles & IDs
Public title
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Scientific title
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Secondary ID [1] 0 0
S62537
Universal Trial Number (UTN)
Trial acronym
APPROACH-IS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease 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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - This is an observational study, there is no intervention

Adults with congenital heart disease -


Other interventions: This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-reported health status
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Patient-reported health status
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Patient-reported depressive symptoms
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Patient-reported anxiety symptoms
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
Patient-reported quality of life
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Patients' perception of providers' autonomy support
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Cognitive functioning
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Frailty phenotype
Timepoint [8] 0 0
Baseline
Secondary outcome [1] 0 0
Patient-reported stigma
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Patient-reported illness identity
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Patient-reported empowerment
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Patient-reported healthcare utilization
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Patient-reported functional status
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Patient-reported social support
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Patient-reported parental involvement
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Advance care planning
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Patient-reported social media to connect with peers
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Presence and burden of comorbidities
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Patient-reported socio-demographic variables (eg. age, educational level)
Timepoint [11] 0 0
Baseline
Secondary outcome [12] 0 0
Medical variables by chart review (eg. diagnosis, cardiac surgeries)
Timepoint [12] 0 0
Baseline

Eligibility
Key inclusion criteria
* Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
* Aged 18 years of age or older at the moment of study inclusion
* Diagnosed with congenital heart disease before the age of 10 years
* Follow-up at an ACHD 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

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
1/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
8415
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Children's Cardiology - 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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Córdoba
Country [12] 0 0
Austria
State/province [12] 0 0
Vienna
Country [13] 0 0
Belgium
State/province [13] 0 0
Ghent
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Botswana
State/province [15] 0 0
Gaborone
Country [16] 0 0
Brazil
State/province [16] 0 0
Ribeirão Preto
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Cameroon
State/province [18] 0 0
Yaoundé
Country [19] 0 0
Canada
State/province [19] 0 0
Edmonton
Country [20] 0 0
Canada
State/province [20] 0 0
Montréal
Country [21] 0 0
Chile
State/province [21] 0 0
Santiago
Country [22] 0 0
Colombia
State/province [22] 0 0
Manizales
Country [23] 0 0
Denmark
State/province [23] 0 0
Copenhagen
Country [24] 0 0
Ethiopia
State/province [24] 0 0
Addis Ababa
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Montpellier
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
Greece
State/province [28] 0 0
Thessaloníki
Country [29] 0 0
India
State/province [29] 0 0
Kochi
Country [30] 0 0
Italy
State/province [30] 0 0
Milan
Country [31] 0 0
Japan
State/province [31] 0 0
Chiba
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Malaysia
State/province [33] 0 0
Kuala Lumpur
Country [34] 0 0
Malta
State/province [34] 0 0
Imsida
Country [35] 0 0
Netherlands
State/province [35] 0 0
Groningen
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Pakistan
State/province [37] 0 0
Karachi
Country [38] 0 0
Portugal
State/province [38] 0 0
Porto
Country [39] 0 0
Senegal
State/province [39] 0 0
Thiès
Country [40] 0 0
Sweden
State/province [40] 0 0
Gothenburg
Country [41] 0 0
Sweden
State/province [41] 0 0
Lund
Country [42] 0 0
Sweden
State/province [42] 0 0
Stockholm
Country [43] 0 0
Sweden
State/province [43] 0 0
Umeå
Country [44] 0 0
Sweden
State/province [44] 0 0
Uppsala
Country [45] 0 0
Switzerland
State/province [45] 0 0
Bern
Country [46] 0 0
Switzerland
State/province [46] 0 0
Genève
Country [47] 0 0
Switzerland
State/province [47] 0 0
Lausanne
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei City
Country [49] 0 0
Turkey
State/province [49] 0 0
Bornova
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Other
Name
KU Leuven
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, RN
Address 0 0
Professor in Healthcare Sciences
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.


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/NCT04902768