Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine.
aCTIVE
A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine
1 other identifier
interventional
600
1 country
1
Brief Summary
A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedSeptember 28, 2017
September 1, 2017
1.3 years
August 28, 2017
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.
Evaluated by a post-consultation memorization survey
At day 1
Secondary Outcomes (4)
Quality score of the support consultation evaluating the memorization of Information by travelers.
At day 1
Level of satisfaction of travelers
At day 1
The relevance of the choice of vaccinations proposed in relation to recommendations
At day 1
The relevance of the choice of prescribed anti-malarials in relation to recommendation
At day 1
Study Arms (2)
Nursing consultation
EXPERIMENTALtravel preventive consultation was performed by nurse
Medical consultation
NO INTERVENTIONtravel preventive consultation was performed by a doctor
Interventions
Eligibility Criteria
You may qualify if:
- Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)
You may not qualify if:
- Children and pregnant women,
- Travellers (man and woman) with co-morbidity factors as:
- Hospitalization in the month previous consultation
- Travelers with at least an one disease including an immune deficiency or dys-immunity, such as auto-immune disease,
- Any recent discovery comorbidity (since less than 6 months)
- Any traveler coming for consultation and bearer of signs of an acute health problem.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne
Bobigny, 93000, France
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine LECLERC, Nurse
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2017
First Posted
September 6, 2017
Study Start
September 25, 2017
Primary Completion
January 1, 2019
Study Completion
August 1, 2019
Last Updated
September 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share