Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 828
- Locations
- 2
- Primary Endpoint
- To evaluate the effectiveness of an intervention combining a patient component and an organisational component
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control group
The randomized centres in this group will not change their practices.
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.
Intervention: Patient component (Other)
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.
Intervention: Organisational component (Other)
Patient and organisational components
The randomized centres in this group will have to implement the two components.
Intervention: Patient component (Other)
Patient and organisational components
The randomized centres in this group will have to implement the two components.
Intervention: Organisational component (Other)
Outcomes
Primary Outcomes
To evaluate the effectiveness of an intervention combining a patient component and an organisational component
Time Frame: Month 6
Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months
Secondary Outcomes
- Intervention components' adaptation(Month 6)
- Patients' health-related quality of life(Baseline, Months 3 and 6)
- Medication compliance(Month 6)
- Number of visits to the patient section of the website(Month 6)
- Acceptability of the intervention for participating centers(Month 6)
- Time to care, in days(Month 6)
- Mortality rate(Months 3 and 6)
- Intervention components' dose and fidelity(Month 6)
- Incremental cost-effectiveness ratio(Month 6)
- Patient knowledge of the disease and the TAVI procedure(Baseline, Month 3)
- Patient satisfaction(Month 6)
- Reached populations(Month 6)
- Number of visits to the professional section of the website(Month 6)