Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 290
- Locations
- 5
- Primary Endpoint
- Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.
Detailed Description
Neurodevelopmental and mental health issues and reduced exercise capacity are the most frequent long-term morbidities in youth with CHD. These problems worsen with age and play a critical role in reducing the quality of life of patients and their families. The QUALI-NEUROREHAB CHD multicentre, randomized controlled trial seeks to test the efficacy of an innovative home-based neuro-cardiac intervention to improve physical and mental health of children, adolescents and young adults with rare CHD, as assessed by the patients themselves using patient-reported outcomes and standardized assessments. Outcomes relate to changes in scores for health-related quality of life (HRQoL, primary outcome measure), neurodevelopmental and mental health outcomes, and cardiopulmonary exercise test parameters, 12 months post-enrolment, in patients with rare CHD aged 8 to 25 years old. This is a two-arm parallel design study: intervention versus control. Intervention using the neuro-cardiac rehabilitation program will be the active arm. Standard of care will be used for the control group and involves normal cardiology consultations and follow-up without intervention programs on physical activity or neurocognitive training. The intervention group will include 12 weeks of neuro-cardiac training, comprised of at-home adaptive physical exercise, telehealth consultations and computerized neurocognitive training as well in-person individual sessions of intervention reinforcement. We hypothesize an increase in the overall HRQoL score of 6 ± 14 points (over 100). With a 90% power, a bilateral alpha risk of 5%, and potentially 20% of loss to follow-up and/or missing data on the primary outcome, we need to randomize 145 patients to each group (N= 290, overall). Analysis will be performed using intent to treat (ITT) approach. We predict significant positive changes in quality of life, mental and physical health scores in patients who will be assigned to the neuro-cardiac intervention (active arm). If this intervention is effective, it can have critical public health implications for the organization and modalities of care for children with rare CHD in Europe. A neuro-cardiac rehabilitation programme tailored to the specific challenges of individuals with rare CHD would improve patient care pathways across major centers in Europe.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)
- •History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
- •Age between 8 and 25 years at the time of enrolment.
- •Parental or legal guardian's consent for minors (\<18 years) and personal consent for adults.
- •Social security affiliation (for France only)
Exclusion Criteria
- •Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (\< 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction \< 50%)
- •Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest \<85%, and/or SpO2 at exercise \<80%, and/or patient requiring oxygen therapy.
- •Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology
- •Significant systolic right ventricle (sRV) hypertension (sRV pressure \> 50% of systemic systolic pressure).
- •Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET.
- •Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
- •Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation \>140/90 mmHg in adults, \>95th percentile in children84).
- •Acute or recent (\< 3 months) myocarditis and pericarditis.
- •Symptomatic aortic or sub-aortic stenosis (mean gradient \> 50 mmHg).
- •Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient \> 20 mmHg.
Outcomes
Primary Outcomes
Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire
Time Frame: between Month 0 and Month 12
Change in the self-reported total score of the PedsQL 4.0 questionnaire between baseline (Month 0) and the end of follow-up (Month 12) in both groups.
Secondary Outcomes
- Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL) for paediatric patients(between Month 0 and Month 12)
- Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)(between Month 0 and Month 12)
- Behaviour Rating Inventory of Executive Function (BRIEF) scale scores(between Month 0 and Month 12)
- Wisconsin Card Sorting Test scale score(between Month 0 and Month 12)
- Wechsler Intelligence Scale scores(between Month 0 and Month 12)
- NEPSY-II scale scores(between Month 0 and Month 12)
- Wechsler Adult Memory Scale scores(between Month 0 and Month 12)
- Vineland questionnaire(between Month 0 and Month 12)
- Multiscore Depression Inventory for Children (MDI-C) scale score(between Month 0 and Month 12)
- Beck's Depression Inventory (BDI) scale score(between Month 0 and Month 12)
- State-Trait Anxiety Inventory (STAI) - Form Y score(between Month 0 and Month 12)
- Revised Child Manifest Anxiety Scale (R-CMAS) score(between Month 0 and Month 12)
- Resilience Scale score(between Month 0 and Month 12)
- Cardiopulmonary exercise test (CPET)(between Month 0 and Month 12)
- Muscular strength(between Month 0 and Month 12)
- Following physical activity questionnaires(between Month 0 and Month 12)
- Metabolic equivalent of task (MET)(between Month 0 and Month 12)