Trials / Completed
CompletedNCT04902768
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8,415 (actual)
- Sponsor
- KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The research aims of this study are: 1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differences in patient-reported experience measures (PREMs), by enrolling adults with congenital heart diseases in low, middle, and high income countries and including new potential explanatory variables ("Part 1"). 2. To explore the profile and healthcare needs of a subgroup of older adults with congenital heart disease, with a particular focus on investigating the frailty phenotype ("Part 2").
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | This is an observational study, there is no intervention | This is an observational study, there is no intervention. Hence, this is not applicable. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2022-08-31
- Completion
- 2022-12-31
- First posted
- 2021-05-26
- Last updated
- 2024-05-16
Locations
53 sites across 32 countries: United States, Argentina, 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
Source: ClinicalTrials.gov record NCT04902768. Inclusion in this directory is not an endorsement.