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Completed

NCT Number: NCT03005626

Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

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Key information

Conditions

Congenital Heart Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, 34295, France

About this study

The number of adults with congenital heart diseases (CHD) is increasing. However, many young adults are lost to follow-up even in experienced tertiary care centers. American and European guidelines recommend to improve the management of young adults with CHD. Structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. Our tertiary care CHD center recently implemented a transition program and simultaneously investigators decided to measure its impact. Indeed investigators need data from randomized trials in this filed. After previous controlled quality of life studies among children and adults with CHD, investigators chose to use the health-related quality of life (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.

The investigators assume that patients who participate in this program will improve their quality of life compared to controls. If investigators demonstrate the benefit of this program, it will have important consequences for patients with CHD and eventually for patients with other chronic medical conditions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient from 13 years to 25 years inclusive.
  • Carrying of Congenital Heart Disease as defined in the International Classification.
  • Possible follow-up for one year on one of the three hospital center.
  • Informed consent of the patient for adults and, parents or legal guardians for minors.
  • Affiliation to a social security system.

Exclusion criteria

  • Non-francophone,
  • Severe intellectual impairment.

Treatment and study plan

Therapeutic education

Other

standard follow-up

Other

Primary outcomes

  1. PedsQL 4.0 score

    Time frame: Follow up of patients over 12 months

    Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.

Secondary outcomes

  1. Physiological parameters

    Time frame: Follow up of patients over 12 months

    Evolution of the physiological parameters during a cardiopulmonary exercise test performed on a treadmill according to a modified Bruce protocole. Evolution of the physiological parameters from month 0 to month 12

  2. Ricci and Gagnon score

    Time frame: Follow up of patients over 12 months

    Evolution of the physical activity assessed by Ricci and Gagnon scores from month 0 to month 12. Ricci and Ganon score is a physical activity self-questionnaire with a total score out of 40 (<16 points: not very active, between 16 and 32 points: fairly active, > 32 points: very active).

  3. Leuven Knowledge score

    Time frame: Follow up of patients over 12 months

    Evolution of the knowledge of the disease assessed by Leuven Knowledge scores from month 0 to month 12. The level of knowledge was assessed by the "transition readdiness assessment" instrument : 10-item questionnaire reflecting the basic knowledge of the diseases and its management.

  4. Disease severity

    Time frame: Follow up of patients over 12 months

    The evolution of the severity of the disease from month 0 to month 12 was assessed by the degree of heart failure (NYHA functionnal class I to IV) and the number of hospitalizations (in stays and days) for complications related to the congenital heart disease

  5. Anxiety and depression

    Time frame: Follow up of patients over 12 months

    The evolution of the levels of depression and/or anxiety from month 0 to month 12 was assessed respectively by :

    • the BDI (Beck Depression Inventory) for young adults
    • the CDI (Child Depression Inventory) for adolescents
    • the STAI (State and Trait Anxiety Inventory) for adults and STAI-C (Children) for adolescents.

    A higher score is associated with a higher risk of depression/anxiety.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2016
Registry last updated
Jun 12, 2026

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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