Methodology
APPROACH-IS II is an international, cross-sectional, descriptive study. Each participating center aims to recruit a minimum of 200 adult patients representing the whole spectrum of mild, moderate and complex congenital heart lesions.
Procedure of recruitment and data collection
The protocol have been registered at ClinicalTrials.gov (NCT04902768).
Procedure of recruitment and data collection
- Postal or online mail-out with random selection of eligible patients from the institution's database
- or Consecutive recruitment of eligible patients at outpatient visit
The protocol have been registered at ClinicalTrials.gov (NCT04902768).
Included variables
Primary Outcome Measures |
Measurement tool |
Perceived Health Status |
The shortened version of the RAND-36 and The Linear Analogue Scale - Health Status (LAS HS) |
Psychological distress |
The Patient Health Questionnaire-8 (PHQ-8) and General Anxiety Disorder 7 (GAD-7) |
Quality of life |
Linear Analog Scale Quality of Life (LAS QOL) |
Cognitive functioning |
The Montréal Cognitive Assessment Screener |
Frailty |
Fried Method (i.e., non-frail/pre-frail/frail) |
Secondary Outcome Measures |
Measurement tool |
Stigma |
Modified Chronic Illness Stigma Scale (CISS) |
Empowerment |
The Gothenburg Empowerment Scale (GES generic v1.1) |
Relationship with health workers |
Modified Health Care Climate Questionnaire (HCCQ) |
Healthcare utilization |
The Patient-Reported Inpatient and Outpatient Utilization Survey (developed by the Steering Committee) |
Illness Identity |
The Illness Identity Questionnaire (IIQ) |
Functional Status |
The Patient-based New York Heart Association (SA-NYHA) assessment |
Perceived Social Support |
The Multidimensional Perceived Social Support Scale |
Social Media to connect with peers |
A survey that have been developed by the Steering Committee |
Parental Involvement |
An adapted version of the items of the Multidimensional Perceived Social Support Scale, retrospectively reflecting perceived social support by parents |
Thinking about the future |
A survey that have been developed by the Steering Committee |
Comorbidities |
The Charlson Comorbidity Index |
Socio-demographic variables |
Self-reported questions |
Medical variables |
By chart review, based on the AP ACHD classification |