Efficacy of a Transition Program in Adolescents and Young Adults With Congenital Heart Disease: The TRANSITION-CHD Randomized Controlled Trial.

PURPOSE: Currently, nearly 90% of patients with congenital heart disease (CHD) reach adulthood in relatively good health. Structured transition programs have emerged to support adolescents and young adults in transitioning to adult care structures, improve their autonomy, and limit healthcare ruptures. The TRANSITION-CHD randomized controlled trial aimed to assess the impact of a transition program on health-related quality of life (HRQoL) in adolescents and young adults with CHD. METHODS: From January 2017 to February 2020, 200 subjects with a CHD, aged 13-25 years, were enrolled in a prospective, controlled, multicenter study and randomized in two balanced groups (transition program vs. standard of care). The primary outcome was the change in PedsQL self-reported HRQoL score between baseline and 12-month follow-up, using an intention-to-treat analysis. The secondary outcomes were the change in disease knowledge, physical health (cardiopulmonary fitness, physical activity), and mental health (anxiety, depression). RESULTS: The change in HRQoL differed significantly between the transition group and the control group (mean difference = 3.03, 95% confidence interval (CI) = [0.08; 5.98]; p = .044; effect size = 0.30), in favor of the intervention group. A significant increase was also observed in the self-reported psychosocial HRQoL (mean difference = 3.33, 95% CI = [0.01; 6.64]; p = .049; effect size = 0.29), in the proxy-reported physical HRQoL (mean difference = 9.18, 95% CI = [1.86; 16.51]; p = .015; effect size = 0.53), and in disease knowledge (mean difference = 3.13, 95% CI = [1.54; 4.72]; p < .001; effect size = 0.64). DISCUSSION: The TRANSITION-CHD program improved HRQoL and disease knowledge in adolescents and young adults with CHD, supporting the generalization and systematization of similar preventive interventions in pediatric and congenital cardiology.

Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8-12 year-old children.

BACKGROUND: The Pediatric Quality of Life Inventory Version 4.0 (PedsQLTM4.0) is a generic health-related quality of life (HRQoL) questionnaire, widely used in pediatric clinical trials but not yet validated in France. We performed the psychometric validation of the self and proxy PedsQLTM4.0 generic questionnaires for French children aged 8-12 years old. METHODS: This bicentric cross-sectional study included 123 children and their parents with congenital heart disease (CHD) and 97 controls. The psychometric validation method was based on the consensus-based standards for the selection of health measurement instruments (COSMIN). The reliability was tested using the intraclass correlation coefficient (ICC). To evaluate the validity of this scale, content, face, criterion, and construct validity psychometric proprieties were tested. Acceptability was studied regarding questionnaires' completion and the existence of a floor or a ceiling effect. RESULTS: Test-retest reliability intra-class correlation coefficients were mainly in good range (0.49-0.66). Face validity was very good among parents (0.85) and children (0.75). Content validity was good (0.70), despite misinterpretation of some items. In construct validity, each subscale had acceptable internal consistency reliability (Cronbach's α > 0.72 in self-reports, > 0.69 in proxy-reports). In the confirmatory factor analysis, the goodness-of-fit statistics rejected the original structure with 4 factors. The exploratory factor analysis revealed an alternative two-factor structure corresponding to physical and psychological dimensions. Convergent validity was supported by moderate (> 0.41) to high correlations (0.57) between PedsQL and Kidscreeen questionnaires for physical, emotion and school dimensions. The ability of the PedsQL to discriminate CHD severity was better with physical, social and total scores for both self-reports and proxy-reports. CONCLUSIONS: The PedsQLTM4.0 generic self and proxy HRQoL questionnaires found good psychometric properties, with regard to acceptability, responsiveness, validity, and reliability. This instrument appeared to be easy to use and comprehend within the target population of children aged 8 to 12 years old and their parents. TRIAL REGISTRATION: This study was approved by the South-Mediterranean-IV Ethics Committee and registered on ClinicalTrials.gov (NCT01202916), https://clinicaltrials.gov/ct2/show/NCT01202916 .

Health-related quality of life in children with congenital heart disease aged 5 to 7 years: a multicentre controlled cross-sectional study.

BACKGROUND: In the context of tremendous progress in congenital cardiology, more attention has been given to patient-related outcomes, especially in assessing health-related quality of life (HRQoL) of patients with congenital heart diseases (CHD). However, most studies have mainly focused on teenagers or adults and currently, few HRQoL controlled data is available in young children. This study aimed to evaluate HRQoL of children with CHD aged 5 to 7 y.o., in comparison with contemporary peers recruited in school, as well as the factors associated with HRQoL in this population. METHODS: This multicentre controlled prospective cross-sectional study included 124 children with a CHD (mean age = 6.0 ± 0.8 y, 45% female) during their outpatient visit and 125 controls (mean age = 6.2 ± 0.8 y, 54% female) recruited at school. A generic paediatric HRQoL instrument was used (PedsQL 4.0). RESULTS: Self-reported HRQoL in children with CHD was similar to controls, overall (73.5 ± 1.2 vs. 72.8 ± 1.2, P = 0.7, respectively), and for each dimension. Parents-reported HRQoL was significantly lower in the CHD group than in controls. HRQoL was predicted by the disease severity and by repeated invasive cardiac procedures (surgery or catheterization). CONCLUSION: HRQoL in young children with CHD aged 5 to 7 years old was good and similar to controls. This study contributed to the growing body of knowledge on HRQoL in congenital cardiology and emphasized the need for child and family support in the most complex CHD. Trial registration This study was approved by the institutional review board of Montpellier University Hospital (2019_IRB-MTP_02-19) on 22 February 2019 and was registered on ClinicalTrials.gov (NCT03931096) on 30 April 2019, https://clinicaltrials.gov/ct2/show/NCT03931096 .

Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring.

BACKGROUND: Managing oral anticoagulant therapy with vitamin K antagonists remains challenging in paediatric medicine. AIMS: This study aimed to assess the correlation between time in therapeutic range and quality of life in children participating in a non-selective International Normalised Ratio self-monitoring and vitamin K antagonist education programme. METHODS: Children aged from 2 to 18 years and receiving vitamin K antagonist therapy were eligible for this prospective multicentre study. Clinical and demographic data were collected. Health-related quality of life was assessed using the PedsQL™ 4.0 questionnaire. Correlations between quality of life scores and time in therapeutic range were measured. RESULTS: A total of 121 children were included in the study (mean age 9.6±4.9 years). Cardiac conditions were the predominant indication for vitamin K antagonists. The mean time in therapeutic range was 0.78±0.15 overall, and 0.76±0.24 over the 3-month period before quality of life assessment. The mean total quality of life score was 76.2±18 in self reports, 71.4±22 in mother reports and 73.5±19 in father reports. The time in therapeutic range correlated with the total quality of life scores in self reports (r=0.22; P=0.04), mother reports (r=0.23; P=0.02) and father reports (r=0.28; P=0.02). The time in therapeutic range predominantly correlated with school functioning in self reports (r=0.38; P=0.002) and mother reports (r=0.40; P<0.001), and with physical functioning in father reports (r=0.28; P=0.03). CONCLUSIONS: Time in therapeutic range correlated with quality of life in children participating in a non-selective International Normalised Ratio self-monitoring and vitamin K antagonist education programme. Regular assessment of quality of life in patient education programmes contributes towards understanding the concerns and needs of patients.

Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods.

BACKGROUND: Recent advances in the field of congenital heart disease (CHD) have significantly improved the overall prognosis. Now more attention is being given to health-related quality of life (HRQoL) and promotion of physical activity. Non-invasive relaxation therapy may be effective in cardiac patients concerned with exercise-induced dyspnoea. The SOPHROCARE randomised trial aims to assess the impact of Caycedian Sophrology on cardiopulmonary fitness in adolescents and young adults with CHD. METHODS: The SOPHROCARE trial is a nationwide, multicentre, randomised, controlled study in CHD patients aged from 13 to 25 years old. Patients will be randomised into 2 groups (8 Sophrology group sessions vs. no intervention). The primary outcome is the change in percent predicted maximum oxygen uptake (VO2max) between baseline and 12-month follow-up. A total of 94 patients in each group is required to observe a significant increase of 10% in VO2max with a power of 80% and an alpha risk of 5%. The secondary outcomes are: clinical outcomes, cardiopulmonary exercise test parameters (VE/VCO2 slope, ventilatory anaerobic threshold, oxygen pulse, respiratory response to hypercapnia), health-related quality of life score (PedsQL), physical and psychological status. CONCLUSION: After focusing on the survival in CHD, current research is opening on secondary prevention and patient-related outcomes. We sought to assess in the SOPHROCARE trial, if a Sophrology program, could improve exercise capacity and quality of life in youth with CHD. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03999320).