Patient-Reported Outcomes in Adults With Congenital Heart Disease (APPROACH-IS)

March 11, 2015 updated by: Philip Moons

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

The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4000

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
      • Córdoba, Argentina
        • Hospital de Ninos
  • Australia
      • Melbourne, Australia
        • Private Practice
  • Belgium
      • Leuven, Belgium
        • University Hospitals Leuven
  • Canada
      • Edmonton, Canada
        • Northern Alberta Adult Congenital Heart Clinic
      • Montreal, Canada
        • Montreal Heart Institute
      • Toronto, Canada
        • Peter Munk Cardiac Center
  • France
      • Lyon, France
        • Hôpital Luis Pradel
  • India
      • Chennai, India
        • Frontier lifeline Hospital
  • Italy
      • Milan, Italy
        • IRCCS Policlinico San Donato Hospital
  • Japan
      • Chiba, Japan
        • Chiba Cardiovascular Center
  • Malta
      • Msida, Malta
        • Mater Dei Hospital
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam Medical Center
  • Norway
      • Oslo, Norway
        • Oslo University Hospital
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital/ Östra
      • Stockholm, Sweden
        • Karolinska Institute
      • Umeå, Sweden
        • University Hospital of Umeå
  • Switzerland
      • Bern, Switzerland
        • University Hospital Bern
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United States
    • California
      • Stanford, California, United States
        • Stanford Hospital & Clinics
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University and Barnes Jewish Heart & Vascular Center
    • Nebraska
      • Omaha, Nebraska, United States
        • Children's Hospital & Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States
        • Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Children's Hospital of Pittsburgh of UPMC

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with congenital heart disease who are in continuing follow-up at an adult congenital heart disease center or included in a national/regional registry.

Description

Inclusion Criteria:

  • Diagnosed with congenital heart disease, defined as: a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and severe heart defects)
  • 18 years of age or older
  • Diagnosed under the age of ten, i.e. before adolescence
  • Continuing follow-up at an adult congenital heart disease center or included in a national/regional registry
  • Physical, cognitive, and language abilities to complete self-report questionnaires

Exclusion Criteria:

  • Prior heart transplantation
  • Isolated pulmonary hypertension
  • Syndromes affecting cognitive abilities

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

Cohorts and Interventions

Group / Cohort
Adults with congenital heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient-reported health status (EuroQol-5D)
Time Frame: Baseline
Baseline
Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)
Time Frame: Baseline
Baseline
Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)
Time Frame: Baseline
Baseline
Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reported sense of coherence (Sense of Coherence scale 13 items)
Time Frame: Baseline
Baseline
Patient-reported illness perceptions (Brief Illness Perception Questionnaire)
Time Frame: Baseline
Baseline
Patient-reported socio-demographic variables (e.g. age, educational level)
Time Frame: Baseline
Baseline
Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Philip Moons

Investigators

  • Study Director: Philip Moons, PhD, KU Leuven
  • Study Director: Koen Luyckx, PhD, KU Leuven
  • Study Director: Adrienne Kovacs, PhD, Peter Munk Cardiac Centre, University Health Network

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

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

April 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML9231

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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