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Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. (aCTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03274180
Recruitment Status : Unknown
Verified September 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 6, 2017
Last Update Posted : September 28, 2017
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Travel and Motion Other: Nursing consultation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental arm: Nurse consultation Non interventional arm: the medical consultation.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nursing consultation
travel preventive consultation was performed by nurse
Other: Nursing consultation
travel preventive consultation was performed by nurse

No Intervention: Medical consultation
travel preventive consultation was performed by a doctor

Primary Outcome Measures :
  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. [ Time Frame: At day 1 ]
    Evaluated by a post-consultation memorization survey

Secondary Outcome Measures :
  1. Quality score of the support consultation evaluating the memorization of Information by travelers. [ Time Frame: At day 1 ]
    Evaluated by memorisation survey

  2. Level of satisfaction of travelers [ Time Frame: At day 1 ]
    The level of satisfaction will be assessed by a visual scale.

  3. The relevance of the choice of vaccinations proposed in relation to recommendations [ Time Frame: At day 1 ]
    will be evaluated by a retrospective review

  4. The relevance of the choice of prescribed anti-malarials in relation to recommendation [ Time Frame: At day 1 ]
    will be evaluated by a retrospective review

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03274180

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Contact: Delphine LECLERC, Nurse 01 48 95 53 42
Contact: Nacira DARGHAL, PhD 01 48 95 74 73

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Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne Recruiting
Bobigny, France, 93000
Contact: Delphine LECLERC, Nurse    01 48 95 53 42   
Contact: BOUCHAUD Olivier, Pr    01 48 95 54 21      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Delphine LECLERC, Nurse Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT03274180    
Other Study ID Numbers: K100104J
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Travel consultation