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

Oscar Werner, Charlene Bredy, Kathleen Lavastre, Sophie Guillaumont, Gregoire De La Villeon, Marie Vincenti, Cristelle Gerl, Yves Dulac, Nathalie Souletie, Philippe Acar, Laurence Pages, Marie-Christine Picot, Gerard Bourrel, Agnes Oude Engberink, Elodie Million, Hamouda Abassi, Pascal Amedro, Oscar Werner, Charlene Bredy, Kathleen Lavastre, Sophie Guillaumont, Gregoire De La Villeon, Marie Vincenti, Cristelle Gerl, Yves Dulac, Nathalie Souletie, Philippe Acar, Laurence Pages, Marie-Christine Picot, Gerard Bourrel, Agnes Oude Engberink, Elodie Million, Hamouda Abassi, Pascal Amedro

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).

Keywords: Adolescent; Congenital heart disease; Quality of life; Therapeutic education; Transition.

Conflict of interest statement

The authors declare that they have no competing interests.

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References

    1. Marelli AJ, Ionescu-Ittu R, Mackie AS, et al. Lifetime prevalence of congenital heart disease in the general population from 2000 to 2010. Circulation. 2014;130:749–756. doi: 10.1161/CIRCULATIONAHA.113.008396.
    1. Marelli AJ, Mackie AS, Ionescu-Ittu R, et al. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2006;115:163–172. doi: 10.1161/CIRCULATIONAHA.106.627224.
    1. Spector LG, Menk JS, Knight JH, et al. Trends in long-term mortality after congenital heart surgery. J Am Coll Cardiol. 2018;71:2434–2446. doi: 10.1016/j.jacc.2018.03.491.
    1. Moons P, Bovijn L, Budts W, et al. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010;122:2264–2272. doi: 10.1161/CIRCULATIONAHA.110.946343.
    1. Mackie AS, Ionescu-Ittu R, Therrien J, et al. Children and adults with congenital heart disease lost to follow-up: who and when? Circulation. 2009;120:302–309. doi: 10.1161/CIRCULATIONAHA.108.839464.
    1. Werner O, Abassi H, Lavastre K, et al. Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: a prospective multicentre controlled study. Patient Educ Couns. 2019;102:2223–2230. doi: 10.1016/j.pec.2019.06.023.
    1. Saha P, Potiny P, Rigdon J, et al. Substantial cardiovascular morbidity in adults with lower-complexity congenital heart disease. Circulation. 2019;139:1889–1899. doi: 10.1161/CIRCULATIONAHA.118.037064.
    1. Wang T, Chen L, Yang T, et al. Congenital heart disease and risk of cardiovascular disease: a meta-analysis of cohort studies. J Am Heart Assoc. 2019;8:e012030.
    1. Sable C, Foster E, Uzark K, et al. Best practices in managing transition to adulthood for adolescents with congenital heart disease: the transition process and medical and psychosocial issues: a scientific statement from the American Heart Association. Circulation. 2011;123:1454–1485. doi: 10.1161/CIR.0b013e3182107c56.
    1. Endorsed by the Association for European Paediatric Cardiology (AEPC), Authors/Task Force Members, Baumgartner H, et al. ESC guidelines for the management of grown-up congenital heart disease (new version 2010): the task force on the management of grown-up congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2915–57.
    1. Uzark K, Smith C, Donohue J, et al. Assessment of transition readiness in adolescents and young adults with heart disease. J Pediatr. 2015;167:1233–1238. doi: 10.1016/j.jpeds.2015.07.043.
    1. Hilderson D, Saidi AS, Van Deyk K, et al. Attitude toward and current practice of transfer and transition of adolescents with congenital heart disease in the United States of America and Europe. Pediatr Cardiol. 2009;30:786–793. doi: 10.1007/s00246-009-9442-1.
    1. Mackie AS, Rempel GR, Kovacs AH, et al. Transition intervention for adolescents with congenital heart disease. J Am Coll Cardiol. 2018;71:1768–1777. doi: 10.1016/j.jacc.2018.02.043.
    1. Amedro P, Dorka R, Moniotte S, et al. Quality of life of children with congenital heart diseases: a multicenter controlled cross-sectional study. Pediatr Cardiol. 2015;36:1588–1601. doi: 10.1007/s00246-015-1201-x.
    1. Amedro P, Gavotto A, Legendre A, et al. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: the QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019;283:112–118. doi: 10.1016/j.ijcard.2018.12.050.
    1. McLoughlin A, Matthews C, Hickey TM. “They’re kept in a bubble”: healthcare professionals’ views on transitioning young adults with congenital heart disease from paediatric to adult care. Child Care Health Dev. 2018;44:736–745. doi: 10.1111/cch.12581.
    1. Keir M, Bailey B, Lee A, et al. Narrative analysis of adults with complex congenital heart disease: childhood experiences and their lifelong reverberations. Congenit Heart Dis. 2018;13:740–747. doi: 10.1111/chd.12647.
    1. Coyne I, Sheehan A, Heery E, et al. Healthcare transition for adolescents and young adults with long-term conditions: qualitative study of patients, parents and healthcare professionals’ experiences. J Clin Nurs. 2019;28:4062–4076. doi: 10.1111/jocn.15006.
    1. Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128:305–310. doi: 10.1097/PRS.0b013e318219c171.
    1. Kabisch M, Ruckes C, Seibert-Grafe M, et al. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011;108:663–668.
    1. Houyel L, Khoshnood B, Anderson RH, et al. Population-based evaluation of a suggested anatomic and clinical classification of congenital heart defects based on the International Paediatric and Congenital Cardiac Code. Orphanet J Rare Dis. 2011;6:64. doi: 10.1186/1750-1172-6-64.
    1. Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001;39:800–812. doi: 10.1097/00005650-200108000-00006.
    1. Tessier S, Vuillemin A, Lemelle J-L, et al. Propriétés psychométriques du questionnaire générique français «Pediatric Quality of Life Inventory Version 4.0» (PedsQLTM 4.0) Revue Européenne de Psychologie Appliquée/Eur Rev Appl Psychol. 2009;59:291–300. doi: 10.1016/j.erap.2009.06.001.
    1. Amedro P, Gavotto A, Guillaumont S, et al. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018;104:1026–1036. doi: 10.1136/heartjnl-2017-312339.
    1. Vuillemin A, Denis G, Guillemin F, et al. A review of evaluation questionnaires for physical activity. Rev Epidemiol Sante Publique. 1998;46:49–55.
    1. Yang H-L, Chen Y-C, Wang J-K, et al. Measuring knowledge of patients with congenital heart disease and their parents: validity of the “Leuven Knowledge Questionnaire for Congenital Heart Disease”. Eur J Cardiovasc Nurs. 2012;11:77–84. doi: 10.1177/1474515111429662.
    1. Kendall PC, Finch AJ, Auerbach SM, et al. The State-Trait Anxiety Inventory: a systematic evaluation. J Consult Clin Psychol. 1976;44:406–412. doi: 10.1037/0022-006X.44.3.406.
    1. Helsel WJ, Matson JL. The assessment of depression in children: the internal structure of the Child Depression Inventory (CDI) Behav Res Ther. 1984;22:289–298. doi: 10.1016/0005-7967(84)90009-3.
    1. Delisle VC, Beck AT, Ziegelstein RC, et al. Symptoms of heart disease or its treatment may increase Beck Depression Inventory Scores in hospitalized post-myocardial infarction patients. J Psychosom Res. 2012;73:157–162. doi: 10.1016/j.jpsychores.2012.07.001.
    1. Amedro P, Tahhan N, Bertet H, et al. Health-related quality of life among children with Turner syndrome: controlled cross-sectional study. J Pediatr Endocrinol Metab. 2017 doi: 10.1515/jpem-2017-0026.
    1. Amedro P, Picot MC, Moniotte S, et al. Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. Int J Cardiol. 2016;203:1052–1060. doi: 10.1016/j.ijcard.2015.11.028.
    1. Amedro P, Bajolle F, Bertet H, et al. Quality of life in children participating in a non-selective INR self-monitoring VKA-education programme. Arch Cardiovasc Dis. 2018;111:180–188. doi: 10.1016/j.acvd.2017.05.013.
    1. Anker SD, Agewall S, Borggrefe M, et al. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014;35:2001–2009. doi: 10.1093/eurheartj/ehu205.
    1. Abassi H, Gavotto A, Picot MC, et al. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019;285:86–92. doi: 10.1016/j.ijcard.2019.02.069.
    1. Apolone G, De Carli G, Brunetti M, et al. Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval. Pharmacoeconomics. 2001;19:187–195. doi: 10.2165/00019053-200119020-00005.
    1. Khankeh H, Ranjbar M, Khorasani-Zavareh D, et al. Challenges in conducting qualitative research in health: a conceptual paper. Iran J Nurs Midwifery Res. 2015;20:635–641. doi: 10.4103/1735-9066.170010.
    1. Charakida M, Georgiopoulos G, Dangardt F, et al. Early vascular damage from smoking and alcohol in teenage years: the ALSPAC study. Eur Heart J. 2019;40:345–353. doi: 10.1093/eurheartj/ehy524.
    1. Luther B, Barra J, Martial M-A. Essential nursing care management and coordination roles and responsibilities: a content analysis. Prof Case Manag. 2019;24:249–258. doi: 10.1097/NCM.0000000000000355.
    1. Jarrín OF, Pouladi FA, Madigan EA. International priorities for home care education, research, practice, and management: Qualitative content analysis. Nurse Educ Today. 2019;73:83–87. doi: 10.1016/j.nedt.2018.11.020.
    1. Logan DR. Transition from hospital to home: the role of the nurse case manager in promoting medication adherence in the medicare population. Creat Nurs. 2019;25:126–132. doi: 10.1891/1078-4535.25.2.126.

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