<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274180</url>
  </required_header>
  <id_info>
    <org_study_id>K100104J</org_study_id>
    <nct_id>NCT03274180</nct_id>
  </id_info>
  <brief_title>Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine.</brief_title>
  <acronym>aCTIVE</acronym>
  <official_title>A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A non inferiority mono-centre randomised single blind prospective study comparing a medical&#xD;
      consultation versus nursing consultation, into two groups parallel without crossover.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The permanent Survey of French data&quot;monitoring of tourist demand&quot; shows that 20% of the&#xD;
      French population over 15 years performed each year at least one trip abroad. Travel most&#xD;
      frequently are destined for European countries (6 times out of 10). The fact remains,&#xD;
      however, that the french travelers (roughly 4.5 million) then fall between 120 countries of&#xD;
      which a quarter part of the health high risk area.&#xD;
&#xD;
      Most of these risks can be minimized if appropriate precautions are observed before, during,&#xD;
      and after the travel.&#xD;
&#xD;
      The development of tourism of people living in France is a real public health issue.&#xD;
&#xD;
      In these conditions, the need for travel medicine becomes more pressing. Medical discipline&#xD;
      in full expansion, it is initially preventive before the trip. The other role of the travel&#xD;
      medicine is the diagnosis and the treatment of the pathology after the end of the travel,&#xD;
      which involves strictly medical skills.&#xD;
&#xD;
      This research investigation is so limited to travel preventive consultation before departure.&#xD;
&#xD;
      Regarding the prevention of the risks related to the trip, the World Health Organization&#xD;
      (WHO) emits the 3 following recommendations:&#xD;
&#xD;
      &quot;Travelers who intend to visit a developing country should consult a travel medicine center&#xD;
      or a doctor, before their departure...&quot;. The main elements to look for by the healthcare&#xD;
      professional who leads the consultation include:&#xD;
&#xD;
        -  an assessment of any potential or underlying health problems&#xD;
&#xD;
        -  a risk assessment linked to the trip according to destination, the route during the&#xD;
           stay, the type of trip, the conditions and the duration of the stay&#xD;
&#xD;
        -  the risk reduction strategy (Council in hygiene, nutrition) including the vaccinations&#xD;
           and recommended therapeutics .&#xD;
&#xD;
      The consultation before the departure, interested on the promotion of health and the&#xD;
      prevention of risks associated with travel. The aim is to propose suitable preventive&#xD;
      measures. It cannot be a stereotyped speech depending on destinations, it is essential to&#xD;
      adapt it to the person's situation.&#xD;
&#xD;
      Healthcare professionals must communicate effectively, so as to promote the understanding and&#xD;
      retention of the information provided. The health promotion is one of the main skills&#xD;
      invested by nurses.&#xD;
&#xD;
      The different investigation invites us to reflect on the new forms of health professionals&#xD;
      cooperation. The investigator believe that the travel medicine offers opportunities in this&#xD;
      way.&#xD;
&#xD;
      The hypothesis is : a nursing consultation in the travel medicine, subject to adequate&#xD;
      training and a perfectly defined framework, can't meet the same criteria of quality of care&#xD;
      than a medical consultation,&#xD;
&#xD;
      The expected results are an equivalence of results in terms of efficiency of support&#xD;
      consultation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental arm: Nurse consultation Non interventional arm: the medical consultation.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.</measure>
    <time_frame>At day 1</time_frame>
    <description>Evaluated by a post-consultation memorization survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality score of the support consultation evaluating the memorization of Information by travelers.</measure>
    <time_frame>At day 1</time_frame>
    <description>Evaluated by memorisation survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of satisfaction of travelers</measure>
    <time_frame>At day 1</time_frame>
    <description>The level of satisfaction will be assessed by a visual scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relevance of the choice of vaccinations proposed in relation to recommendations</measure>
    <time_frame>At day 1</time_frame>
    <description>will be evaluated by a retrospective review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relevance of the choice of prescribed anti-malarials in relation to recommendation</measure>
    <time_frame>At day 1</time_frame>
    <description>will be evaluated by a retrospective review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Travel and Motion</condition>
  <arm_group>
    <arm_group_label>Nursing consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>travel preventive consultation was performed by nurse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical consultation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>travel preventive consultation was performed by a doctor</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nursing consultation</intervention_name>
    <description>travel preventive consultation was performed by nurse</description>
    <arm_group_label>Nursing consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Traveler (male and female) over 18 years old (coming for travel consultation in a&#xD;
             international center of vaccination)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and pregnant women,&#xD;
&#xD;
          -  Travellers (man and woman) with co-morbidity factors as:&#xD;
&#xD;
               -  Hospitalization in the month previous consultation&#xD;
&#xD;
               -  Travelers with at least an one disease including an immune deficiency or&#xD;
                  dys-immunity, such as auto-immune disease,&#xD;
&#xD;
               -  Any recent discovery comorbidity (since less than 6 months)&#xD;
&#xD;
               -  Any traveler coming for consultation and bearer of signs of an acute health&#xD;
                  problem.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Delphine LECLERC, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Delphine LECLERC, Nurse</last_name>
    <phone>01 48 95 53 42</phone>
    <email>leclercd1@hotmail.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nacira DARGHAL, PhD</last_name>
    <phone>01 48 95 74 73</phone>
    <email>nacira.darghal@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine LECLERC, Nurse</last_name>
      <phone>01 48 95 53 42</phone>
      <email>leclercd1@hotmail.fr</email>
    </contact>
    <contact_backup>
      <last_name>BOUCHAUD Olivier, Pr</last_name>
      <phone>01 48 95 54 21</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Travel consultation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274180
org study id: K100104J
nct id: NCT03274180
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A non inferiority mono-centre randomised single blind prospective study comparing a medical
      consultation versus nursing consultation, into two groups parallel without crossover.
The permanent Survey of French data"monitoring of tourist demand" shows that 20% of the
      French population over 15 years performed each year at least one trip abroad. Travel most
      frequently are destined for European countries (6 times out of 10). The fact remains,
      however, that the french travelers (roughly 4.5 million) then fall between 120 countries of
      which a quarter part of the health high risk area.

      Most of these risks can be minimized if appropriate precautions are observed before, during,
      and after the travel.

      The development of tourism of people living in France is a real public health issue.

      In these conditions, the need for travel medicine becomes more pressing. Medical discipline
      in full expansion, it is initially preventive before the trip. The other role of the travel
      medicine is the diagnosis and the treatment of the pathology after the end of the travel,
      which involves strictly medical skills.

      This research investigation is so limited to travel preventive consultation before departure.

      Regarding the prevention of the risks related to the trip, the World Health Organization
      (WHO) emits the 3 following recommendations:

      "Travelers who intend to visit a developing country should consult a travel medicine center
      or a doctor, before their departure...". The main elements to look for by the healthcare
      professional who leads the consultation include:

        -  an assessment of any potential or underlying health problems

        -  a risk assessment linked to the trip according to destination, the route during the
           stay, the type of trip, the conditions and the duration of the stay

        -  the risk reduction strategy (Council in hygiene, nutrition) including the vaccinations
           and recommended therapeutics .

      The consultation before the departure, interested on the promotion of health and the
      prevention of risks associated with travel. The aim is to propose suitable preventive
      measures. It cannot be a stereotyped speech depending on destinations, it is essential to
      adapt it to the person's situation.

      Healthcare professionals must communicate effectively, so as to promote the understanding and
      retention of the information provided. The health promotion is one of the main skills
      invested by nurses.

      The different investigation invites us to reflect on the new forms of health professionals
      cooperation. The investigator believe that the travel medicine offers opportunities in this
      way.

      The hypothesis is : a nursing consultation in the travel medicine, subject to adequate
      training and a perfectly defined framework, can't meet the same criteria of quality of care
      than a medical consultation,

      The expected results are an equivalence of results in terms of efficiency of support
      consultation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental arm: Nurse consultation Non interventional arm: the medical consultation.
primary purpose: Prevention
masking: Single (Participant)
measure: Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.
time frame: At day 1
description: Evaluated by a post-consultation memorization survey
measure: Quality score of the support consultation evaluating the memorization of Information by travelers.
time frame: At day 1
description: Evaluated by memorisation survey
measure: Level of satisfaction of travelers
time frame: At day 1
description: The level of satisfaction will be assessed by a visual scale.
measure: The relevance of the choice of vaccinations proposed in relation to recommendations
time frame: At day 1
description: will be evaluated by a retrospective review
measure: The relevance of the choice of prescribed anti-malarials in relation to recommendation
time frame: At day 1
description: will be evaluated by a retrospective review
arm group label: Nursing consultation
arm group type: Experimental
description: travel preventive consultation was performed by nurse
arm group label: Medical consultation
arm group type: No Intervention
description: travel preventive consultation was performed by a doctor
intervention type: Other
intervention name: Nursing consultation
description: travel preventive consultation was performed by nurse
arm group label: Nursing consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Delphine LECLERC, Nurse
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Delphine LECLERC, Nurse
phone: 01 48 95 53 42
email: leclercd1@hotmail.fr
last name: Nacira DARGHAL, PhD
phone: 01 48 95 74 73
email: nacira.darghal@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
sharing ipd: No