Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

  • End date
    Dec 31, 2021
  • participants needed
  • sponsor
    KU Leuven
Updated on 4 June 2021


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.


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").

Condition Congenital Heart Disease
Treatment This is an observational study, there is no intervention
Clinical Study IdentifierNCT04902768
SponsorKU Leuven
Last Modified on4 June 2021


Yes No Not Sure

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

Exclusion Criteria

Prior heart transplantation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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