At a glance
ClinicalIndex Comparison RecordN/ACompleted· 8,415 enrolled
Drug / intervention
This is an observational study, there is no interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
In Brief
An observational study evaluating This is an observational study, there is no intervention for Congenital Heart Disease. Completed, enrolled 8,415 participants across 53 sites in 32 countries.
Detailed Summary
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesArgentina, Australia, Austria, Belgium, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, Colombia, Denmark, Ethiopia, France, Greece, India, Italy, Japan, Malaysia, Malta, Netherlands, Norway, Pakistan, Portugal, Senegal, South Korea, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedMay 2021
Primary CompletionAug 2022
Study CompletionDec 2022
TodayJul 2026
First PostedMay 26, 2021
Enrollment StartAug 1, 2019
Primary CompletionAug 31, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.1 years ago
Interventions
This is an observational study, there is no interventionother
This is an observational study, there is no intervention. Hence, this is not applicable.