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

Congenital Heart Disease Clinical Trial

— APPROACH-IS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902768
• Other study ID #: S62537
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8167
• Est. completion date: November 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.

Locations

Country	Name	City	State
Argentina	Hospital San Juan De Dios De La Plata	Buenos Aires
Argentina	Hospital de Niños	Córdoba
Australia	Melbourne Children's Cardiology	Melbourne
Austria	Vienna General Hospital	Vienna
Belgium	Ghent University Hospital	Ghent
Belgium	University Hospitals Leuven	Leuven
Botswana	Princess Marina Hospital	Gaborone
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto
Bulgaria	National Heart Hospital	Sofia
Cameroon	Clinique Medical Le Jourdain	Yaoundé
Canada	Mazankowski Alberta Heart Institute	Edmonton
Canada	Montreal Heart Institute, Université de Montréal	Montréal
Chile	Intituto Nacional Del Torax	Santiago
Colombia	Meintegral Clinic	Manizales
Denmark	Copenhagen University Hospital	Copenhagen
Ethiopia	College of Health sciences, Addis Ababa University	Addis Ababa
France	Hôpital cardiologique Haut-Leveque	Bordeaux
France	Montpellier University Hospital	Montpellier
France	Hôpital Européen Georges Pompidou	Paris
Greece	AHEPA University Hospital	Thessaloníki
India	Amrita Institute of Medical Sciences	Kochi
Italy	Policlinico San Donato (IRCCS)	Milan
Japan	Chiba Cerebral and Cardiovascular Center	Chiba
Korea, Republic of	Samsung Medical Center	Seoul
Malaysia	Paediatric & Congenital Heart Centre, IJN (National Heart Institute)	Kuala Lumpur
Malta	Mater Dei Hospital	Imsida
Netherlands	Centrum voor Congenital Hartafwijkingen	Groningen
Norway	Oslo University Hospital, Rikshospitalet	Oslo
Pakistan	Aga Khan University Hospital	Karachi
Portugal	Reference Center of Congenital Heart Disease , University Hospital Center of São João	Porto
Senegal	Centre Hospitalier Régional de Thiès	Thiès
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Skånes Universitetssjukhus	Lund
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Umea University Hospital	Umeå
Sweden	Uppsala University Hospital	Uppsala
Switzerland	University Hospital Bern	Bern
Switzerland	Hôpitaux Universitaires de Genève	Genève
Switzerland	Centre Hospitalier universitaire vaudois	Lausanne
Taiwan	National Taiwan University Hospital	Taipei City
Turkey	Ege University Health Application and Research Center, Cardiology Department	Bornova
United Kingdom	Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United States	Taussig Heart Center of Johns Hopkins Hospital	Baltimore	Maryland
United States	Boston Children's / Brigham and Women's	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Southwestern Medical Center	Dallas	Texas
United States	University of Florida Health	Gainesville	Florida
United States	Mount Sinai Heart	New York	New York
United States	Philadelphia Penn Medicine	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California	San Francisco	California
United States	Lucile Packard Children's Hospital and Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Botswana,  Brazil,  Bulgaria,  Cameroon,  Canada,  Chile,  Colombia,  Denmark,  Ethiopia,  France,  Greece,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Malta,  Netherlands,  Norway,  Pakistan,  Portugal,  Senegal,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported health status	This outcome is measured using the shortened version of the RAND-36. Composite physical (PCS) and mental health (MCS) scores are computed. Scores range from 0 (lowest health level) to 100 (highest health level).	Baseline
Primary	Patient-reported health status	This outcome is measured using the Linear Analogue Scale Health Status (LAS HS). Scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline
Primary	Patient-reported depressive symptoms	This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of =10 indicate depression.	Baseline
Primary	Patient-reported anxiety symptoms	This outcome is measured using the General Anxiety Disorder 7. Scores range from 0 to 21. Scores of 5, 10, and 15 are taken as cut-off points for mild, moderate and severe anxiety.	Baseline
Primary	Patient-reported quality of life	This outcome is measured using the Linear Analog Scale on Quality of Life (LAS QOL). Scores range from 0 (worst imaginable quality of life) to 100 (best imaginable quality of life).	Baseline
Primary	Patients' perception of providers' autonomy support	This outcome is measured using the modified Health Care Climate Questionnaire (mHCCQ). Each of the 6 items is scored from 1 to 7. Scores are calculated by averaging the individual item scores. Higher average score represents a higher level of perceived autonomy support.	Baseline
Primary	Cognitive functioning	This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction.	Baseline
Primary	Frailty phenotype	This outcome is classified using the Fried method (i.e., non-frail (no positive criterion), pre-frail (1 or 2 criteria positive), or frail (when =3 criteria are positive).	Baseline
Secondary	Patient-reported stigma	This outcome is measured using the Chronic Illness Stigma Scale (CISS). Scores range from 8 to 40. Higher scores indicating higher levels of perceived stigma.	Baseline
Secondary	Patient-reported illness identity	This outcome is measured using the Illness Identity Questionnaire (IIQ). The questionnaire consists of a five-item rejection scale, seven-item enrichment scale, five-item acceptance scale and eight-item engulfment scale. A mean score is calculated per subscale. Higher scores indicate more rejection, enrichment, acceptance or engulfment.	Baseline
Secondary	Patient-reported empowerment	This outcome is measured using the Gothenburg Empowerment Scale (GES generic v1.1). Scores range from 15 to 75. Higher score reflects a higher level of empowerment.	Baseline
Secondary	Patient-reported healthcare utilization	This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.	Baseline
Secondary	Patient-reported functional status	This outcome is classified according to the New York Heart Association (NYHA).	Baseline
Secondary	Patient-reported social support	This outcomes is measured using the Multidimensional Scale on Perceived Social Support Scale (MSPSS). Scores range from 12 to 84. Higher score indicates greater social support perceived by an individual.	Baseline
Secondary	Patient-reported parental involvement	This outcome is measured using an adapted version of the subscale on parents of the Multidimensional Scale on Perceived Social Support. Scores range from 5 to 35. Higher score indicates greater parental support in childhood and adolescence.	Baseline
Secondary	Advance care planning	This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'Have you personally written down information about the care you would want in case you become seriously ill in the future?'.	Baseline
Secondary	Patient-reported social media to connect with peers	This outcome is measured using a survey developed for APPROACH-IS II by the Steering Committee, based on previous research. A sample question is 'How would you describe your experiences connecting with other people with CHD through social media?'.	Baseline
Secondary	Presence and burden of comorbidities	This outcome is measured using the Charlson Comorbidity Index.	Baseline
Secondary	Patient-reported socio-demographic variables (eg. age, educational level)	Self-reported	Baseline
Secondary	Medical variables by chart review (eg. diagnosis, cardiac surgeries)	This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.	Baseline

External Links

•   Methods paper of APPROACH-IS II