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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02150603
Other study ID # ML9231
Secondary ID
Status Completed
Phase N/A
First received May 21, 2014
Last updated March 11, 2015
Start date April 2013
Est. completion date February 2015

Study information

Verified date March 2015
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Argentina: Hospital de Niños, institutional review boardAustralia: Monash Health Melbourne, institutional review boardBelgium: University Hospitals Leuven, institutional review boardCanada: University of Alberta, institutional review boardCanada: Montreal Heart Institute, institutional review boardCanada: Peter Munk Cardiac Center Toronto, institutional review boardFrance: Luis Pradel Hospital Lyon, institutional review boardIndia: Frontier Lifeline Hospital Chennai, institutional review boardItaly: IRCCS Policlinico San Donato Hospital Milan, institutional review boardJapan: Chiba Cardiovascular Center, institutional review boardMalta: Mater Dei Hospital, institutional review boardNorway: Oslo University Hospital, institutional review boardTaiwan: National Taiwan University Hospital, institutional review boardSweden: Sahlgrenska University Hospital, institutional review boardUnited States: Cincinnati Children's Hospital Medical Center, institutional review boardUnited States: Nationwide Children's Hospital Columbus, institutional review boardUnited States: Children's Hospital of Pittsburgh of UPMC, institutional review boardUnited States: Children's Hospital & Medical Center Omaha, institutional review boardUnited States: Washington University and Barnes Jewish Heart & Vascular Center Saint Louis, institutional review boardUnited States: Stanford Hospital & Clinics, institutional review board
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 4000
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Time Perspective: Cross-Sectional


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Philip Moons

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  France,  India,  Italy,  Japan,  Malta,  Netherlands,  Norway,  Sweden,  Switzerland,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported health status (EuroQol-5D) Baseline No
Primary Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale) Baseline No
Primary Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease) Baseline No
Primary Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale) Baseline No
Secondary Patient-reported sense of coherence (Sense of Coherence scale 13 items) Baseline No
Secondary Patient-reported illness perceptions (Brief Illness Perception Questionnaire) Baseline No
Secondary Patient-reported socio-demographic variables (e.g. age, educational level) Baseline No
Secondary Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up) Baseline No
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