Une brève intervention de tâche cognitive pour le personnel du NHS affecté par un traumatisme lié au COVID-19 (étude GAINS-2) (GAINS-2)
Un essai contrôlé randomisé d'une brève intervention de tâche cognitive pour aider le personnel du NHS à vivre des souvenirs intrusifs d'événements traumatisants liés au travail pendant la pandémie de COVID-19.
Le personnel de santé de première ligne est fréquemment exposé à des événements traumatisants au travail (par exemple, voir des patients mourir), amplifiés par la pandémie de COVID-19. Une proportion importante d'entre eux vivent des souvenirs intrusifs de ces événements qui surgissent soudainement à l'esprit : ils peuvent perturber le fonctionnement et contribuer au trouble de stress post-traumatique. Des recherches antérieures ont montré qu'une brève intervention comportementale peut réduire le nombre de souvenirs intrusifs après un événement traumatique. Dans cette étude, nous testerons l'effet d'une tâche concurrente d'imagerie numérique, d'une tâche d'écoute de musique numérique et d'un traitement habituel (TAU) pour le personnel du National Health Service (NHS) avec des souvenirs intrusifs d'événements traumatisants liés au travail de la pandémie. Nous testons l'effet sur le nombre de souvenirs intrusifs (résultat principal) et d'autres symptômes cliniques (ESPT, anxiété, dépression et insomnie), en plus du fonctionnement au travail, du fonctionnement général et de la qualité de vie (résultats secondaires). La faisabilité, l'acceptabilité et la mise en œuvre de l'intervention seront également explorées (résultats supplémentaires). Nous recruterons environ 150 membres du personnel du NHS (via l'Intensive Care Society, les médias sociaux et la publicité directe par NHS Trusts) avec des souvenirs intrusifs d'événements traumatisants vécus pendant la pandémie de COVID-19.
L'étude est financée par le Wellcome Trust (223016/Z/21/Z).
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Un plan d'analyse statistique sera préparé avant la première analyse intermédiaire en utilisant des analyses bayésiennes pour l'inférence statistique.
Une surveillance régulière sera effectuée par P1vital Products pour vérifier que l'étude est menée et que les données sont générées, documentées et rapportées conformément au protocole, aux BPC et aux exigences réglementaires applicables. Les représentants de l'assurance qualité du promoteur peuvent effectuer un audit de l'étude conformément aux directives réglementaires et aux procédures opérationnelles standard pertinentes.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Oxfordshire
-
Wallingford, Oxfordshire, Royaume-Uni, OX10 8BA
- P1vital Products Ltd
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- 18 ans ou plus.
- Capable de lire, écrire et parler en anglais.
- A travaillé dans un rôle clinique avec des patients COVID-19 dans le NHS pendant la pandémie de COVID-19.
- A vécu au moins un événement traumatique lié à son travail clinique pendant la pandémie de COVID-9 répondant au critère A du Manuel diagnostique et statistique des troubles mentaux, 5e édition (DSM-5) des critères de l'état de stress post-traumatique (ESPT) : « exposition à la mort réelle ou imminente, à des blessures graves ou à des violences sexuelles » en « vivant directement le ou les événements traumatisants » ou « en étant témoin, en personne, du ou des événements tels qu'ils se sont produits pour les autres ».
- Vivez des souvenirs intrusifs de l'événement ou des événements traumatisants.
- A vécu au moins trois souvenirs intrusifs dans la semaine précédant le dépistage.
- Avoir accès à Internet.
- Volonté et capable de fournir un consentement éclairé et de compléter les procédures d'étude
- Être disposé et capable d'être contacté par l'équipe de recherche pendant la période d'étude.
- N'ont pas participé à une étude précédente de cette intervention de cette équipe de recherche
Critère d'exclusion:
• Avoir moins de trois souvenirs intrusifs pendant la semaine de rodage.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Brève tâche d'imagerie numérique concurrente
Accès à une brève tâche concurrente d'imagerie numérique pendant 24 semaines (4 premières semaines avec le soutien facultatif du chercheur).
|
Première séance guidée par un chercheur : Un repère de mémoire suivi d'un jeu informatique avec des consignes de rotation mentale. Possibilité de participer à des séances auto-administrées/guidées après la première séance. |
|
Expérimental: Brève tâche d'écoute de musique numérique
Accès à une brève tâche d'écoute de musique numérique pendant 24 semaines (les 4 premières semaines avec le soutien facultatif du chercheur).
|
Première séance guidée par un chercheur : Information sur la musique du compositeur suivie d'une écoute de musique classique. Possibilité de participer à des séances auto-administrées/guidées après la première séance. |
|
Expérimental: Traitement comme d'habitude
Accès aux soins de routine que les participants recevraient autrement s'ils avaient des souvenirs intrusifs d'événements traumatisants pendant 24 semaines.
|
Accès aux soins de routine que les participants recevraient autrement s'ils avaient des souvenirs intrusifs d'événements traumatisants.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Intrusive Memories of Traumatic Event(s)
Délai: Run-in/screening week, Week 4 (all arms)
|
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
|
Run-in/screening week, Week 4 (all arms)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Indicateur de condition de sommeil (SCI)
Délai: Base de référence, 4 semaines, 12 semaines et 24 semaines (tous les bras)
|
Cette échelle à 2 éléments mesure les problèmes de sommeil par rapport aux critères du DSM-5 pour les troubles de l'insomnie.
Les réponses aux éléments sont chacune notées de 0 à 4, les scores de 0 à 2 indiquant les critères seuils du trouble d'insomnie.
Le score total varie de 0 à 8, un score plus élevé indiquant un meilleur sommeil.
|
Base de référence, 4 semaines, 12 semaines et 24 semaines (tous les bras)
|
|
Number of Intrusive Memories of Traumatic Event(s)
Délai: Run-in/Screening week, Weeks 12 and 24 (all arms)
|
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
|
Run-in/Screening week, Weeks 12 and 24 (all arms)
|
|
PTSD Checklist for DSM-5 (PCL-5)
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This 20-item measure assesses symptoms of PTSD over the last week.
Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").
Scores are summed to give a total severity score (ranging 0 to 80), with greater scores indicating greater symptom severity.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Generalised Anxiety Disorder 2-item Scale (GAD-2)
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This 2-item short-form self-report measure assesses symptoms of anxiety.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Patient Health Questionnaire 2-item Version (PHQ-2)
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This 2-item short-form self-report measure assesses symptoms of depression.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work engagement subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work engagement.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work burnout subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work burnout.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Sickness Absence
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
Single item assessing self-reported number of sick days taken from work in the last 4 weeks.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Intention to Leave Job
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
3 items assess participants' intention to leave their job e.g.
"I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree).
The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The mobility item is scored on a 5-point ordinal scale from "I have no problems in walking about" to "I am unable to walk about".
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care
Délai: Baseline, Week 4, Week 12 and Week 24
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The self care item is scored on a 5-point ordinal scale from "I have no problems washing or dressing myself" to "I am unable to wash or dress myself".
|
Baseline, Week 4, Week 12 and Week 24
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities
Délai: Baseline, Week 4, Week 12 and Week 24
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The usual activities item is scored on a 5-point ordinal scale from "I have no problems doing my usual activities" to "I am unable to do my usual activities".
|
Baseline, Week 4, Week 12 and Week 24
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort
Délai: Baseline, Week 4, Week 12 and Week 24
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The pain / discomfort item is scored on a 5-point ordinal scale from "I have no pain or discomfort" to "I have extreme pain or discomfort".
|
Baseline, Week 4, Week 12 and Week 24
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression
Délai: Baseline, Week 4, Week 12 and Week 24
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The anxiety / depression item is scored on a 5-point ordinal scale from "I am not anxious or depressed" to "I am extremely anxious or depressed".
|
Baseline, Week 4, Week 12 and Week 24
|
|
5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health
Délai: Baseline, Week 4, Week 12 and Week 24
|
The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.
Respondents rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
|
Baseline, Week 4, Week 12 and Week 24
|
|
World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.
Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do).
The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points), with greater scores indicating greater impairment.
|
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?
Délai: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 1 assessing the frequency of intrusive memories on a 7-point scale from 'never' to 'many times a day'. Other items from this questionnaire are presented below. |
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Intrusive Memory Ratings: Item 4a. Duration of Interference
Délai: Baseline, Week 4, Week 12 and Week 24 (all arms)
|
This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 4a assessing the for how long intrusive memories interfered with what participants were doing on a 7-point scale from '<1 min' to '>60 mins'. Other items from this questionnaire are presented below. |
Baseline, Week 4, Week 12 and Week 24 (all arms)
|
|
Intrusive Memory Ratings: Distress (Item 2), Disruption to Concentration (Item 3), Interference (Item 4), Impact on Work Functioning (Item 5), and Impact on Functioning in Other Areas of Life (Item 7)
Délai: Baseline, Week 4, Week 12 and Week 24 (all arms)
|
This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present data for the five items scored on an 11-point scale (0=not at all to 10=extremely) assessing distress (Item 2), disruption to concentration (Item 3), interference (Item 4), impact on work functioning (Item 5), and impact on functioning in other areas of life (Item 7). |
Baseline, Week 4, Week 12 and Week 24 (all arms)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes to Health and Work - Dichotomous Outcomes
Délai: 4 weeks, 12 weeks and 24 weeks (all arms)
|
The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Dichotomous outcomes are presented below, and discrete outcomes with count data are presented under "Changes to health and work - discrete outcomes".
|
4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Changes to Health and Work - Discrete Outcomes
Délai: 4 weeks, 12 weeks and 24 weeks (all arms)
|
The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Discrete outcomes are presented below, and dichotomous outcomes are presented under "Changes to health and work - dichotomous outcomes".
|
4 weeks, 12 weeks and 24 weeks (all arms)
|
|
Feedback Questionnaire
Délai: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
|
A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cogntive task, both with an open response.
|
After 4 weeks (brief imagery-competing task and brief music listening task arms only)
|
|
Feedback Questionnaire (Total Score)
Délai: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
|
A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very); items for distress and burden are reverse scored from 0 (very) to 10 (not at all).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cognitive task, both with an open response.
A total score of the eight categorical items is presented (range 0 - 80), with greater scores indicating more favourable feedback towards the allocated digital task.
|
After 4 weeks (brief imagery-competing task and brief music listening task arms only)
|
|
Optional Qualitative Interview
Délai: Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
|
This semi-structured interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the brief cognitive task, including acceptability, improvement suggestions, and potential barriers/facilitators to implementation.
|
Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
|
|
Weekly Work Pattern, Number of Days Worked
Délai: Baseline, Week 4, Week 12 and Week 24
|
One item asses the number of days worked in the last week (both with responses from 0 to 7 days).
|
Baseline, Week 4, Week 12 and Week 24
|
|
Weekly Work Pattern, Number of Night Shifts Worked
Délai: Baseline, Week 4, Week 12 and Week 24
|
One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).
|
Baseline, Week 4, Week 12 and Week 24
|
|
Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Categorical Items
Délai: Day 0 (post-randomisation)
|
The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
|
Day 0 (post-randomisation)
|
|
Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Total Score
Délai: Day 0 (post-randomisation)
|
The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
|
Day 0 (post-randomisation)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Emily Holmes, Uppsala University (UU), Sweden
- Chercheur principal: Amy Beckenstrom, P1vital Products, Wallingford
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P1V-GAINS-IN02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Les données de recherche anonymisées seront mises à disposition sur l'OSF indéfiniment.
OSF est une application web open source librement accessible au public et à la communauté scientifique.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .