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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01899365 |
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Date of registration:
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04/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
IMPROVED |
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Scientific title:
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An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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1475 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01899365 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Monaco
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Contacts
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Name:
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Jocelyn RAUDE, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ecole des Hautes Etudes en Santé Publique |
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Name:
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José LABARERE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble |
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Name:
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Yann-Erick CLAESSENS, MD-PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Princesse Grace |
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Name:
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Xavier DUVAL, MD-PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupe Hospitalier Bichat Claude-Bernard |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients 65-year old and above,
- benefit from French or Monaco social security a social security.
Exclusion Criteria:
- refuse to participate,
- no possibility to receive SMS,
- impaired cognitive functions and mental status precluding understanding of the study,
- anticipated barriers precluding adequate follow-up (ex. homeless),
- previous APV,
- contraindication to APV,
- do not understand/read French.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pneumococcal Infections
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Primary Outcome(s)
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Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : ? percentage (%) of APV vaccination at 6-month
[Time Frame: 6 month]
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Secondary Outcome(s)
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On death at 6- and 12-month (absolute number of events)
[Time Frame: 6 month]
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On death related to infection at 6- and 12-month (absolute number of events)
[Time Frame: 6 month]
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On episodes of respiratory tract infections requiring antibiotics or admission at 6-month ? (absolute number of events)
[Time Frame: 6 month]
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On Flu vaccination at 6-month ? percentage (%)
[Time Frame: 6 month]
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Psychosocial evaluation of patients and acceptance / refusal of vaccination
[Time Frame: 6 month]
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Secondary ID(s)
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12-09
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2013-A00943-42
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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