Patient-Reported Outcomes in Adults With Congenital Heart Disease

Heart Defects, Congenital Clinical Trial

— APPROACH-IS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150603
• Other study ID #: ML9231
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases

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

External Links

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