Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients

Aortic Valve Stenosis Clinical Trial

— TREAT  

Official title:

Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237804
• Other study ID #: 2021/0226/HP
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Rouen
• Contact: Helene Eltchaninoff, Pr
• Phone: +33232888232
• Email: helene.eltchaninoff[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 748
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Other:
• Patient component
Video, booklet, website
• Organisational component
Coronarography, CT-scan, anesthesia...

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of an intervention combining a patient component and an organisational component	Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months	Month 6
Secondary	Time to care, in days	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	Month 6
Secondary	Mortality rate	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	Months 3 and 6
Secondary	Patients' health-related quality of life	Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).	Baseline, Months 3 and 6
Secondary	Patient knowledge of the disease and the TAVI procedure	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).	Baseline, Month 3
Secondary	Medication compliance	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).	Month 6
Secondary	Patient satisfaction	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	Month 6
Secondary	Number of visits to the patient section of the website	The number of visits to the website will be assessed through Googleanalytics®	Month 6
Secondary	Number of visits to the professional section of the website	The number of visits to the website will be assessed through Googleanalytics®	Month 6
Secondary	Acceptability of the intervention for participating centers	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.	Month 6
Secondary	Intervention components' dose and fidelity	Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.	Month 6
Secondary	Reached populations	Percentage of target individuals who benefit from activities of each component of the intervention	Month 6
Secondary	Intervention components' adaptation	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.	Month 6
Secondary	Incremental cost-effectiveness ratio	The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire	Month 6