APPROACH-IS II
  • Home
  • Project
    • What is APPROACH-IS II ?
    • Rationale
    • Aims
    • Methodology
    • Progress
  • Consortium
    • Steering Committee
    • Participating Centers
    • Stakeholders
  • Media
    • News
    • Publications
    • Presentations
    • Info flashes
  • Information for participating centers
    • Standard Operating Procedures
    • Document and Data Storage
  • The first APPROACH-IS project
  • Contact

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
  1. Postal or online mail-out with random selection of eligible patients from the institution's database
  2. 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
  • Home
  • Project
    • What is APPROACH-IS II ?
    • Rationale
    • Aims
    • Methodology
    • Progress
  • Consortium
    • Steering Committee
    • Participating Centers
    • Stakeholders
  • Media
    • News
    • Publications
    • Presentations
    • Info flashes
  • Information for participating centers
    • Standard Operating Procedures
    • Document and Data Storage
  • The first APPROACH-IS project
  • Contact