Back to resultsEvaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients (TREAT)
Primary Purpose
Aortic Valve Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient component
Organisational component
Sponsored by
About this trial
This is an interventional other trial for Aortic Valve Stenosis focused on measuring Aortic Stenosis, Treatment time, Medico-economy
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
Sites / Locations
- Brest University HospitalRecruiting
- CHU de RouenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control group
Patient component
Organisational component
Patient and organisational components
Arm Description
The randomized centres in this group will not change their practices.
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.
The randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times.
The randomized centres in this group will have to implement the two components.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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).
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).
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).
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
Number of visits to the patient section of the website
The number of visits to the website will be assessed through Googleanalytics®
Number of visits to the professional section of the website
The number of visits to the website will be assessed through Googleanalytics®
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.
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.
Reached populations
Percentage of target individuals who benefit from activities of each component of the intervention
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.
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
Full Information
NCT ID
NCT05237804
First Posted
December 23, 2021
Last Updated
May 12, 2023
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT05237804
Brief Title
Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
Acronym
TREAT
Official Title
Evaluation d'Une Intervention Pour Reduire le Delai de Traitement Des Patients Traites Par TAVI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Stenosis, Treatment time, Medico-economy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, there is a randomization of the participating centres in 4 groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
748 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The randomized centres in this group will not change their practices.
Arm Title
Patient component
Arm Type
Experimental
Arm Description
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.
Arm Title
Organisational component
Arm Type
Experimental
Arm Description
The randomized centres in this group will be provided with a list of organisational changes to be implemented to improve patient care times.
Arm Title
Patient and organisational components
Arm Type
Experimental
Arm Description
The randomized centres in this group will have to implement the two components.
Intervention Type
Other
Intervention Name(s)
Patient component
Intervention Description
Video, booklet, website
Intervention Type
Other
Intervention Name(s)
Organisational component
Intervention Description
Coronarography, CT-scan, anesthesia...
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of an intervention combining a patient component and an organisational component
Description
Percentage of patients with a TAVI indication with a time to TAVI procedure of less than 2 months
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Time to care, in days
Description
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
Time Frame
Month 6
Title
Mortality rate
Description
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
Time Frame
Months 3 and 6
Title
Patients' health-related quality of life
Description
Patients' health-related quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L).
Time Frame
Baseline, Months 3 and 6
Title
Patient knowledge of the disease and the TAVI procedure
Description
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).
Time Frame
Baseline, Month 3
Title
Medication compliance
Description
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).
Time Frame
Month 6
Title
Patient satisfaction
Description
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
Time Frame
Month 6
Title
Number of visits to the patient section of the website
Description
The number of visits to the website will be assessed through Googleanalytics®
Time Frame
Month 6
Title
Number of visits to the professional section of the website
Description
The number of visits to the website will be assessed through Googleanalytics®
Time Frame
Month 6
Title
Acceptability of the intervention for participating centers
Description
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 Frame
Month 6
Title
Intervention components' dose and fidelity
Description
Number of different activities really performed for each component of the intervention / number of activities planned for each component according to the protocol.
Time Frame
Month 6
Title
Reached populations
Description
Percentage of target individuals who benefit from activities of each component of the intervention
Time Frame
Month 6
Title
Intervention components' adaptation
Description
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.
Time Frame
Month 6
Title
Incremental cost-effectiveness ratio
Description
The incremental cost-effectiveness ratio will be expressed in cost per quality-adjusted life-year (QALY) gained, derived from the EQ-5D-5L questionnaire
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene Eltchaninoff, Pr
Phone
+33232888232
Email
helene.eltchaninoff@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Béziau-Gasnier, PhD
Phone
+33232886766
Email
delphine.beziau-gasnier@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Eltchaninoff, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brest University Hospital
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Gilard, Pr
First Name & Middle Initial & Last Name & Degree
Martine Gilard
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Eltchaninoff, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
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