Clinical trial NCT04902768: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Official title: APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Quality of life
Patient reported outcomes
Patient reported experience measures
Geriatric phenotype
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 8415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with congenital heart disease who are in follow-up at an adult congenital heart disease center or included in a national/regional registry.

For Part 1 of this study, each participating center will aim to recruit 200 adult patients with CHD aged 18 years or older with simple, moderate, or complex congenital heart disease. For Part 2 of this study, within these samples of 200 patients, centers will aim to recruit about 20 adults aged 40-50y, 20 adults aged 50-60y and 20 adults aged \>60 years who are diagnosed with moderate to great disease complexity.

Depending on the data collection method, sampling is at random or consecutive. Both a probability and convenience sample can be used.

Brief summary: 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.

Detailed description: 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").

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported health status
timeFrame: Baseline
measure: Patient-reported health status
timeFrame: Baseline
measure: Patient-reported depressive symptoms
timeFrame: Baseline
measure: Patient-reported anxiety symptoms
timeFrame: Baseline
measure: Patient-reported quality of life
timeFrame: Baseline
measure: Patients' perception of providers' autonomy support
timeFrame: Baseline
measure: Cognitive functioning
timeFrame: Baseline
measure: Frailty phenotype
timeFrame: Baseline
Secondary outcomes:
measure: Patient-reported stigma
timeFrame: Baseline
measure: Patient-reported illness identity
timeFrame: Baseline
measure: Patient-reported empowerment
timeFrame: Baseline
measure: Patient-reported healthcare utilization
timeFrame: Baseline
measure: Patient-reported functional status
timeFrame: Baseline
measure: Patient-reported social support
timeFrame: Baseline
measure: Patient-reported parental involvement
timeFrame: Baseline
measure: Advance care planning
timeFrame: Baseline
measure: Patient-reported social media to connect with peers
timeFrame: Baseline
measure: Presence and burden of comorbidities
timeFrame: Baseline
measure: Patient-reported socio-demographic variables (eg. age, educational level)
timeFrame: Baseline
measure: Medical variables by chart review (eg. diagnosis, cardiac surgeries)
timeFrame: Baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital and Stanford Health Care
state: California
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Baltimore
country: United States
facility: Taussig Heart Center of Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Children's / Brigham and Women's
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Heart
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia Penn Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: University of Southwestern Medical Center
state: Texas
city: Buenos Aires
country: Argentina
facility: Hospital San Juan De Dios De La Plata
city: Córdoba
country: Argentina
facility: Hospital de Niños
city: Melbourne
country: Australia
facility: Melbourne Children's Cardiology
city: Vienna
country: Austria
facility: Vienna General Hospital
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
city: Sofia
country: Bulgaria
facility: National Heart Hospital
city: Yaoundé
country: Cameroon
facility: Clinique Medical Le Jourdain
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
city: Montréal
country: Canada
facility: Montreal Heart Institute, Université de Montréal
city: Santiago
country: Chile
facility: Intituto Nacional Del Torax
city: Manizales
country: Colombia
facility: Meintegral Clinic
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Addis Ababa
country: Ethiopia
facility: College of Health sciences, Addis Ababa University
city: Bordeaux
country: France
facility: Hôpital cardiologique Haut-Leveque
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences
city: Milan
country: Italy
facility: Policlinico San Donato (IRCCS)
city: Chiba
country: Japan
facility: Chiba Cerebral and Cardiovascular Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Paediatric & Congenital Heart Centre, IJN (National Heart Institute)
city: Imsida
country: Malta
facility: Mater Dei Hospital
city: Groningen
country: Netherlands
facility: Centrum voor Congenital Hartafwijkingen
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Porto
country: Portugal
facility: Reference Center of Congenital Heart Disease , University Hospital Center of São João
city: Thiès
country: Senegal
facility: Centre Hospitalier Régional de Thiès
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Umeå
country: Sweden
facility: Umea University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier universitaire vaudois
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Bornova
country: Turkey
facility: Ege University Health Application and Research Center, Cardiology Department
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Professor in Healthcare Sciences
name: Philip Moons, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.