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

NCT ID: NCT03274180

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2019-08-01

Brief Summary

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A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover.

Detailed Description

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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.

Conditions

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Travel and Motion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental arm: Nurse consultation Non interventional arm: the medical consultation.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Nursing consultation

travel preventive consultation was performed by nurse

Group Type EXPERIMENTAL

Nursing consultation

Intervention Type OTHER

travel preventive consultation was performed by nurse

Medical consultation

travel preventive consultation was performed by a doctor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing consultation

travel preventive consultation was performed by nurse

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine LECLERC, Nurse

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne

Bobigny, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Delphine LECLERC, Nurse

Role: CONTACT

01 48 95 53 42

Nacira DARGHAL, PhD

Role: CONTACT

01 48 95 74 73

Facility Contacts

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Delphine LECLERC, Nurse

Role: primary

01 48 95 53 42

BOUCHAUD Olivier, Pr

Role: backup

01 48 95 54 21

Other Identifiers

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K100104J

Identifier Type: -

Identifier Source: org_study_id