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OpenTrials
Completed

NCT Number: NCT02150603

Patient-Reported Outcomes in Adults With Congenital Heart Disease

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).

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Key information

Conditions

Heart Defects, Congenital Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Depression Health Behavior Heart Diseases Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Niños, Córdoba, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient-reported health status (EuroQol-5D)

    Time frame: Baseline

  2. Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale)

    Time frame: Baseline

  3. Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease)

    Time frame: Baseline

  4. Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale)

    Time frame: Baseline

Secondary outcomes

  1. Patient-reported sense of coherence (Sense of Coherence scale 13 items)

    Time frame: Baseline

  2. Patient-reported illness perceptions (Brief Illness Perception Questionnaire)

    Time frame: Baseline

  3. Patient-reported socio-demographic variables (e.g. age, educational level)

    Time frame: Baseline

  4. Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Philip Moons

Other

Registry information

Official study title

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

Acronym: APPROACH-IS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 30, 2014
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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