for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

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


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").


Congenital Heart Disease Quality of life Patient reported outcomes Patient reported experience measures Geriatric phenotype Heart Diseases Heart Defects, Congenital


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Prior heart transplantation


  • University of California accepting new patients
    San Francisco California 92093-0021 United States
  • Lucile Packard Children's Hospital and Stanford Health Care accepting new patients
    Stanford California 94304 United States


accepting new patients
Start Date
Completion Date
KU Leuven
Study Type
Last Updated