Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial.
Identifieur interne : 000018 ( Main/Exploration ); précédent : 000017; suivant : 000019Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial.
Auteurs : Oscar Werner [France] ; Charlene Bredy [France] ; Kathleen Lavastre [France] ; Sophie Guillaumont [France] ; Gregoire De La Villeon [France] ; Marie Vincenti [France] ; Cristelle Gerl [France] ; Yves Dulac [France] ; Nathalie Souletie [France] ; Philippe Acar [France] ; Laurence Pages [France] ; Marie-Christine Picot [France] ; Gerard Bourrel [France] ; Agnes Oude Engberink [France] ; Elodie Million [France] ; Hamouda Abassi [France] ; Pascal Amedro [France]Source :
- Health and quality of life outcomes [ 1477-7525 ] ; 2021.
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English descriptors
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Abstract
BACKGROUND
Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patients to become independent and responsible. The TRANSITION-CHD randomized trial aims to assess the impact of a transition education program on health-related quality of life (HRQoL) of adolescents and young adults with CHD.
METHODS
Multicentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (education program vs. no intervention). The primary outcome is the change in self-reported HRQoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall HRQoL score of 7 ± 13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (peak VO2, VAT, VE/VCO2 slope), level of knowledge of the disease using the Leuven knowledge questionnaire for CHD, physical and psychological status.
DISCUSSION
As the current research is opening on patient related outcomes, and as the level of proof in therapeutic education is still low, we sought to assess the efficacy of a therapeutic education program on HRQoL of CHD patients with a randomized trial.
TRIAL REGISTRATION
This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).
DOI: 10.1186/s12955-021-01668-1
PubMed: 33468144
PubMed Central: PMC7814637
Affiliations:
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Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Acar, Philippe" sort="Acar, Philippe" uniqKey="Acar P" first="Philippe" last="Acar">Philippe Acar</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse 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University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of General Medicine, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Million, Elodie" sort="Million, Elodie" uniqKey="Million E" first="Elodie" last="Million">Elodie Million</name><affiliation wicri:level="3"><nlm:affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of General Medicine, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Abassi, Hamouda" sort="Abassi, Hamouda" uniqKey="Abassi H" first="Hamouda" last="Abassi">Hamouda Abassi</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Amedro, Pascal" sort="Amedro, Pascal" uniqKey="Amedro P" first="Pascal" last="Amedro">Pascal Amedro</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33468144</idno><idno type="pmid">33468144</idno><idno type="doi">10.1186/s12955-021-01668-1</idno><idno 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xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Bredy, Charlene" sort="Bredy, Charlene" uniqKey="Bredy C" first="Charlene" last="Bredy">Charlene Bredy</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Lavastre, Kathleen" sort="Lavastre, Kathleen" uniqKey="Lavastre K" first="Kathleen" last="Lavastre">Kathleen Lavastre</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Guillaumont, Sophie" sort="Guillaumont, Sophie" uniqKey="Guillaumont S" first="Sophie" last="Guillaumont">Sophie Guillaumont</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots</wicri:regionArea><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion></affiliation></author><author><name sortKey="De La Villeon, Gregoire" sort="De La Villeon, Gregoire" uniqKey="De La Villeon G" first="Gregoire" last="De La Villeon">Gregoire De La Villeon</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots</wicri:regionArea><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion></affiliation></author><author><name sortKey="Vincenti, Marie" sort="Vincenti, Marie" uniqKey="Vincenti M" first="Marie" last="Vincenti">Marie Vincenti</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots</wicri:regionArea><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion><wicri:noRegion>Palavas-Les-Flots</wicri:noRegion></affiliation><affiliation wicri:level="3"><nlm:affiliation>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Gerl, Cristelle" sort="Gerl, Cristelle" uniqKey="Gerl C" first="Cristelle" last="Gerl">Cristelle Gerl</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Dulac, Yves" sort="Dulac, Yves" uniqKey="Dulac Y" first="Yves" last="Dulac">Yves Dulac</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Souletie, Nathalie" sort="Souletie, Nathalie" uniqKey="Souletie N" first="Nathalie" last="Souletie">Nathalie Souletie</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Acar, Philippe" sort="Acar, Philippe" uniqKey="Acar P" first="Philippe" last="Acar">Philippe Acar</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Pages, Laurence" sort="Pages, Laurence" uniqKey="Pages L" first="Laurence" last="Pages">Laurence Pages</name><affiliation wicri:level="3"><nlm:affiliation>Epidemiology and Clinical Research Department, University Hospital, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Epidemiology and Clinical Research Department, University Hospital, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Picot, Marie Christine" sort="Picot, Marie Christine" uniqKey="Picot M" first="Marie-Christine" last="Picot">Marie-Christine Picot</name><affiliation wicri:level="3"><nlm:affiliation>Epidemiology and Clinical Research Department, University Hospital, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Epidemiology and Clinical Research Department, University Hospital, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Bourrel, Gerard" sort="Bourrel, Gerard" uniqKey="Bourrel G" first="Gerard" last="Bourrel">Gerard Bourrel</name><affiliation wicri:level="3"><nlm:affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of General Medicine, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Oude Engberink, Agnes" sort="Oude Engberink, Agnes" uniqKey="Oude Engberink A" first="Agnes" last="Oude Engberink">Agnes Oude Engberink</name><affiliation wicri:level="3"><nlm:affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of General Medicine, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Million, Elodie" sort="Million, Elodie" uniqKey="Million E" first="Elodie" last="Million">Elodie Million</name><affiliation wicri:level="3"><nlm:affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of General Medicine, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Abassi, Hamouda" sort="Abassi, Hamouda" uniqKey="Abassi H" first="Hamouda" last="Abassi">Hamouda Abassi</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Amedro, Pascal" sort="Amedro, Pascal" uniqKey="Amedro P" first="Pascal" last="Amedro">Pascal Amedro</name><affiliation wicri:level="3"><nlm:affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier</wicri:regionArea><placeName><region type="region" nuts="2">Occitanie (région administrative)</region><region type="old region" nuts="2">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author></analytic><series><title level="j">Health and quality of life outcomes</title><idno type="eISSN">1477-7525</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Heart Defects, Congenital (psychology)</term><term>Humans (MeSH)</term><term>Patient Education as Topic (MeSH)</term><term>Quality of Life (MeSH)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Research Design (MeSH)</term><term>Transition to Adult Care (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term><term>Adulte (MeSH)</term><term>Cardiopathies congénitales (psychologie)</term><term>Essais contrôlés randomisés comme sujet (MeSH)</term><term>Humains (MeSH)</term><term>Jeune adulte (MeSH)</term><term>Plan de recherche (MeSH)</term><term>Qualité de vie (MeSH)</term><term>Transition aux soins pour adultes (MeSH)</term><term>Éducation du patient comme sujet (MeSH)</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Cardiopathies congénitales</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Heart Defects, Congenital</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Humans</term><term>Patient Education as Topic</term><term>Quality of Life</term><term>Randomized Controlled Trials as Topic</term><term>Research Design</term><term>Transition to Adult Care</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Jeune adulte</term><term>Plan de recherche</term><term>Qualité de vie</term><term>Transition aux soins pour adultes</term><term>Éducation du patient comme sujet</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patients to become independent and responsible. The TRANSITION-CHD randomized trial aims to assess the impact of a transition education program on health-related quality of life (HRQoL) of adolescents and young adults with CHD.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Multicentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (education program vs. no intervention). The primary outcome is the change in self-reported HRQoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall HRQoL score of 7 ± 13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (peak VO2, VAT, VE/VCO2 slope), level of knowledge of the disease using the Leuven knowledge questionnaire for CHD, physical and psychological status.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>As the current research is opening on patient related outcomes, and as the level of proof in therapeutic education is still low, we sought to assess the efficacy of a therapeutic education program on HRQoL of CHD patients with a randomized trial.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" IndexingMethod="Curated" Owner="NLM"><PMID Version="1">33468144</PMID><DateCompleted><Year>2021</Year><Month>03</Month><Day>01</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>01</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1477-7525</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>1</Issue><PubDate><Year>2021</Year><Month>Jan</Month><Day>19</Day></PubDate></JournalIssue><Title>Health and quality of life outcomes</Title><ISOAbbreviation>Health Qual Life Outcomes</ISOAbbreviation></Journal><ArticleTitle>Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>23</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12955-021-01668-1</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Recent advances in the field of congenital heart disease (CHD) led to an improved prognosis of the patients and in consequence the growth of a new population: the grown up with congenital heart disease. Until recently, more than 50% of these patients were lost to follow up because of the lack of specialized structures. The critical moment is the transition between paediatric and adult unit. Therapeutic education is crucial to solve this issue by helping patients to become independent and responsible. The TRANSITION-CHD randomized trial aims to assess the impact of a transition education program on health-related quality of life (HRQoL) of adolescents and young adults with CHD.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Multicentre, randomised, controlled, parallel arm study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (education program vs. no intervention). The primary outcome is the change in self-reported HRQoL between baseline and 12-month follow-up. A total of 100 patients in each group is required to observe a significant increase of the overall HRQoL score of 7 ± 13.5 points (on 100) with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (peak VO2, VAT, VE/VCO2 slope), level of knowledge of the disease using the Leuven knowledge questionnaire for CHD, physical and psychological status.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">As the current research is opening on patient related outcomes, and as the level of proof in therapeutic education is still low, we sought to assess the efficacy of a therapeutic education program on HRQoL of CHD patients with a randomized trial.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">This study was approved by the National Ethics Committee (South-Mediterranean IV 2016-A01681-50) and was registered on Clinicaltrials.gov (NCT03005626).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Werner</LastName><ForeName>Oscar</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bredy</LastName><ForeName>Charlene</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lavastre</LastName><ForeName>Kathleen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guillaumont</LastName><ForeName>Sophie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>De La Villeon</LastName><ForeName>Gregoire</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vincenti</LastName><ForeName>Marie</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Pediatric Cardiology and Rehabilitation Unit, St-Pierre Institute, Palavas-Les-Flots, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gerl</LastName><ForeName>Cristelle</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dulac</LastName><ForeName>Yves</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Souletie</LastName><ForeName>Nathalie</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Acar</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, Toulouse University Hospital, Toulouse, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pages</LastName><ForeName>Laurence</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Epidemiology and Clinical Research Department, University Hospital, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Picot</LastName><ForeName>Marie-Christine</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Epidemiology and Clinical Research Department, University Hospital, Montpellier, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bourrel</LastName><ForeName>Gerard</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oude Engberink</LastName><ForeName>Agnes</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Million</LastName><ForeName>Elodie</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of General Medicine, University of Montpellier, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abassi</LastName><ForeName>Hamouda</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Amedro</LastName><ForeName>Pascal</ForeName><Initials>P</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-3649-0294</Identifier><AffiliationInfo><Affiliation>Pediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, University Hospital, 371 Avenue du Doyen Giraud, 34295, Montpellier, France. pascal.amedro@gmail.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Investigation Centre, INSERM-CIC 1411, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>PhyMedExp, INSERM, CNRS, University of Montpellier, Montpellier, France. pascal.amedro@gmail.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT03005626</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>Bourse Hélène de Marsan</GrantID><Agency>Société Française de Cardiologie</Agency><Country></Country></Grant><Grant><GrantID>GIRCI-SOHO-APIRES-2017</GrantID><Agency>Direction de l'hospitalisation et de l'offre de Soins</Agency><Country></Country></Grant><Grant><GrantID>AOI-2016</GrantID><Agency>Centre Hospitalier Régional Universitaire de Montpellier</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D000078325">Clinical Trial Protocol</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Health Qual Life Outcomes</MedlineTA><NlmUniqueID>101153626</NlmUniqueID><ISSNLinking>1477-7525</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006330" MajorTopicYN="N">Heart Defects, Congenital</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010353" MajorTopicYN="Y">Patient Education as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="Y">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D060305" MajorTopicYN="Y">Transition to Adult Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Adolescent</Keyword><Keyword MajorTopicYN="N">Congenital heart disease</Keyword><Keyword MajorTopicYN="N">Quality of life</Keyword><Keyword MajorTopicYN="N">Therapeutic education</Keyword><Keyword MajorTopicYN="N">Transition</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>31</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2021</Year><Month>01</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>1</Month><Day>20</Day><Hour>5</Hour><Minute>37</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>1</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>3</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33468144</ArticleId><ArticleId IdType="doi">10.1186/s12955-021-01668-1</ArticleId><ArticleId 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