Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: Organisational componentOther: Patient component
- Registration Number
- NCT05237804
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).
Once a diagnosis has been made and the decision to treat these patients has been taken, the procedure (AVR or TAVI) must be performed rapidly given the poor prognosis of the disease without treatment. Studies have shown that on the waiting list, the probability of death and hospitalisation for heart failure increases with time. This delay could also reduce the effectiveness of TAVI, thus affecting the performance of the healthcare system.
In this study, an intervention combining an e-health component (tool intended for patients, families and health professionals in contact with patients), and an organisational component (for TAVI implanting centres) has been designed. The aim of this study is to evaluate the effectiveness of this intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 748
- Patient over 18 years of age;
- Aortic stenosis
- Indication of TAVI
- Patient affiliated or benefiting from a health insurance scheme
- Patient having read and understood the information letter and having signed the consent form
- TAVI indication not retained
- Patient who are not fluent in French and have no one around them to translate,
- Patient who do not have access to the Internet (at home or in their immediate environment)
- Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ;
- Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curators
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Organisational component Organisational component The randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times. Patient and organisational components Organisational component The randomized centres in this group will have to implement the two components. Patient component Patient component The randomized centres in this group will be required to present patients with: * A short introductory video, viewed on a tablet during hospitalization for coronary angiography, * A paper booklet, * A website. Patient and organisational components Patient component The randomized centres in this group will have to implement the two components.
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of an intervention combining a patient component and an organisational component Month 6 Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months
- Secondary Outcome Measures
Name Time Method Patients' health-related quality of life Baseline, Months 3 and 6 Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).
Medication compliance Month 6 Patient medication compliance will be measured using a questionnaire developed by Girerd et al, with a score going from 0 (lowest compliance) to 6 (maximum compliance).
Number of visits to the patient section of the website Month 6 The number of visits to the website will be assessed through Googleanalytics®
Intervention components' adaptation Month 6 Number of activities performed which have been modified to adapt them to the local context / total number of activities performed. A description of the adaptations performed will be provided.
Acceptability of the intervention for participating centers Month 6 The acceptability of the intervention will be assessed through an ad hoc questionnaire addressed to TAVI centers and peripheral hospitals performing the coronary angiography of the pre-TAVI assessment.
Time to care, in days Month 6 The time to care is the number of days between the date of the initial consultation during which a TAVI is proposed and the date of the TAVI procedure
Mortality rate Months 3 and 6 The mortality rate will be measured between the initial consultation during which a TAVI is proposed and the TAVI procedure, and in the three months following the procedure
Intervention components' dose and fidelity Month 6 Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.
Incremental cost-effectiveness ratio Month 6 The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire
Patient knowledge of the disease and the TAVI procedure Baseline, Month 3 Patients' knowledge of the disease and the TAVI procedure will be measured by their score to an ad hoc questionnaire (0: minimum score - 26: maximum score).
Patient satisfaction Month 6 Patient satisfaction with the care they received and (for the group receiving the patient component) with the patient component of the intervention will be measured using a 0 to 10 Likert scale
Reached populations Month 6 Percentage of target individuals who benefit from activities of each component of the intervention
Number of visits to the professional section of the website Month 6 The number of visits to the website will be assessed through Googleanalytics®
Trial Locations
- Locations (2)
Brest University Hospital
🇫🇷Brest, France
CHU de Rouen
🇫🇷Rouen, France