Patient-Reported Outcomes in Adults With Congenital Heart Disease

Completed

• Conditions: Heart Defects, Congenital

• Registration Number: NCT02150603
• Lead Sponsor: Philip Moons

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (24)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Washington University and Barnes Jewish Heart & Vascular Center; 🇺🇸 Saint Louis, Missouri, United States

Stanford Hospital & Clinics; 🇺🇸 Stanford, California, United States

Hôpital Luis Pradel; 🇫🇷 Lyon, France

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital & Medical Center; 🇺🇸 Omaha, Nebraska, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Private practice; 🇦🇺 Melbourne, Australia

Hospital de Niños; 🇦🇷 Córdoba, Argentina

Montreal Heart Institute; 🇨🇦 Montreal, Canada

Northern Alberta Adult Congenital Heart Clinic; 🇨🇦 Edmonton, Canada

Peter Munk Cardiac Center; 🇨🇦 Toronto, Canada

Frontier Lifeline Hospital; 🇮🇳 Chennai, India

IRCCS Policlinico San Donato Hospital; 🇮🇹 Milan, Italy

Chiba Cardiovascular Center; 🇯🇵 Chiba, Japan

Mater Dei Hospital; 🇲🇹 Msida, Malta

Amsterdam Medical Center; 🇳🇱 Amsterdam, Netherlands

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Sahlgrenska University Hospital/ Östra; 🇸🇪 Gothenburg, Sweden

University Hospital of Umeå; 🇸🇪 Umeå, Sweden

University Hospital Bern; 🇨🇭 Bern, Switzerland

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan