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

May 15, 2024 updated by: Philip Moons, KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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").

Study Type

Observational

Enrollment (Actual)

8415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital San Juan De Dios De La Plata
      • Córdoba, Argentina
        • Hospital de Niños
  • Australia
      • Melbourne, Australia
        • Melbourne Children's Cardiology
  • Austria
      • Vienna, Austria
        • Vienna General Hospital
  • Belgium
      • Ghent, Belgium
        • Ghent University Hospital
      • Leuven, Belgium
        • University Hospitals Leuven
  • Botswana
      • Gaborone, Botswana
        • Princess Marina Hospital
  • Brazil
      • Ribeirão Preto, Brazil
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Bulgaria
      • Sofia, Bulgaria
        • National Heart Hospital
  • Cameroon
      • Yaoundé, Cameroon
        • Clinique Medical Le Jourdain
  • Canada
      • Edmonton, Canada
        • Mazankowski Alberta Heart Institute
      • Montréal, Canada
        • Montreal Heart Institute, Université de Montréal
  • Chile
      • Santiago, Chile
        • Intituto Nacional Del Torax
  • Colombia
      • Manizales, Colombia
        • Meintegral Clinic
  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital
  • Ethiopia
      • Addis Ababa, Ethiopia
        • College of Health Sciences, Addis Ababa University
  • France
      • Bordeaux, France
        • Hôpital Cardiologique Haut-Lévêque
      • Montpellier, France
        • Montpellier University Hospital
      • Paris, France
        • Hôpital Européen Georges Pompidou
  • Greece
      • Thessaloníki, Greece
        • Ahepa University Hospital
  • India
      • Kochi, India
        • Amrita Institute of Medical Sciences
  • Italy
      • Milan, Italy
        • Policlinico San Donato (IRCCS)
  • Japan
      • Chiba, Japan
        • Chiba Cerebral and Cardiovascular Center
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Paediatric & Congenital Heart Centre, IJN (National Heart Institute)
  • Malta
      • Imsida, Malta
        • Mater dei hospital
  • Netherlands
      • Groningen, Netherlands
        • Centrum voor Congenital Hartafwijkingen
  • Norway
      • Oslo, Norway
        • Oslo University Hospital, Rikshospitalet
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan University Hospital
  • Portugal
      • Porto, Portugal
        • Reference Center of Congenital Heart Disease , University Hospital Center of São João
  • Senegal
      • Thiès, Senegal
        • Centre Hospitalier Régional de Thiès
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Lund, Sweden
        • Skånes universitetssjukhus
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset
      • Umeå, Sweden
        • Umeå University Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
  • Switzerland
      • Bern, Switzerland
        • University Hospital Bern
      • Genève, Switzerland
        • Hôpitaux Universitaires de Genève
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • Taiwan
      • Taipei City, Taiwan
        • National Taiwan University Hospital
  • Turkey
      • Bornova, Turkey
        • Ege University Health Application and Research Center, Cardiology Department
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust
      • Newcastle, United Kingdom
        • Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
  • United States
    • California
      • San Francisco, California, United States, 92093-0021
        • University of California
      • Stanford, California, United States, 94304
        • Lucile Packard Children's Hospital and Stanford Health Care
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida Health
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Taussig Heart Center of Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's / Brigham and Women's
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Heart
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia Penn Medicine
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with congenital heart disease
Other: This is an observational study, there is no intervention
This is an observational study, there is no intervention. Hence, this is not applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported health status
Time Frame: Baseline
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
Patient-reported health status
Time Frame: Baseline
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
Patient-reported depressive symptoms
Time Frame: Baseline
This outcomes is measured using the Patient Health Questionnaire 8. Scores range from 0 to 24. Scores of ≥10 indicate depression.
Baseline
Patient-reported anxiety symptoms
Time Frame: Baseline
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
Patient-reported quality of life
Time Frame: Baseline
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
Patients' perception of providers' autonomy support
Time Frame: Baseline
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
Cognitive functioning
Time Frame: Baseline
This outcome is measured using the Montreal Cognitive Assessment Screener (MoCA). Scores range from 0 to 30. Scores of <26 indicate cognitive dysfunction.
Baseline
Frailty phenotype
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported stigma
Time Frame: Baseline
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
Patient-reported illness identity
Time Frame: Baseline
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
Patient-reported empowerment
Time Frame: Baseline
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
Patient-reported healthcare utilization
Time Frame: Baseline
This outcomes was measured using the Patient-Reported Inpatient and outpatient Utilization Survey (PRIUS). Higher numbers indicate more healthcare use.
Baseline
Patient-reported functional status
Time Frame: Baseline
This outcome is classified according to the New York Heart Association (NYHA).
Baseline
Patient-reported social support
Time Frame: Baseline
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
Patient-reported parental involvement
Time Frame: Baseline
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
Advance care planning
Time Frame: Baseline
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
Patient-reported social media to connect with peers
Time Frame: Baseline
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
Presence and burden of comorbidities
Time Frame: Baseline
This outcome is measured using the Charlson Comorbidity Index.
Baseline
Patient-reported socio-demographic variables (eg. age, educational level)
Time Frame: Baseline
Self-reported
Baseline
Medical variables by chart review (eg. diagnosis, cardiac surgeries)
Time Frame: Baseline
This outcome is classified according to the adult congenital heart disease anatomic and physiological (ACHD AP) classification system of Stout and colleagues.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Philip Moons, PhD, RN, Professor in Healthcare Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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