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.
A total of 83 centers, located in 40 countries have confirmed participation in APPROACH-IS II. The list of participating centers can be found here.
Procedure of recruitment and data collection
The protocol have been registered at ClinicalTrials.gov.
A total of 83 centers, located in 40 countries have confirmed participation in APPROACH-IS II. The list of participating centers can be found here.
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.
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 |