Clinical trial NCT05237804: Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
Official title: Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Stenosis
Treatment time
Medico-economy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, there is a randomization of the participating centres in 4 groups.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effectiveness of an intervention combining a patient component and an organisational component
timeFrame: Month 6
Secondary outcomes:
measure: Time to care, in days
timeFrame: Month 6
measure: Mortality rate
timeFrame: Months 3 and 6
measure: Patients' health-related quality of life
timeFrame: Baseline, Months 3 and 6
measure: Patient knowledge of the disease and the TAVI procedure
timeFrame: Baseline, Month 3
measure: Medication compliance
timeFrame: Month 6
measure: Patient satisfaction
timeFrame: Month 6
measure: Number of visits to the patient section of the website
timeFrame: Month 6
measure: Number of visits to the professional section of the website
timeFrame: Month 6
measure: Acceptability of the intervention for participating centers
timeFrame: Month 6
measure: Intervention components' dose and fidelity
timeFrame: Month 6
measure: Reached populations
timeFrame: Month 6
measure: Intervention components' adaptation
timeFrame: Month 6
measure: Incremental cost-effectiveness ratio
timeFrame: Month 6
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Helene Eltchaninoff, Pr
role: PRINCIPAL_INVESTIGATOR
References: