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

A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03274180
Acronym
aCTIVE
Enrollment
600
Registered
2017-09-06
Start date
2017-09-25
Completion date
2019-08-01
Last updated
2017-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Travel and Motion

Keywords

Travel consultation

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.

Detailed description

The permanent Survey of French datamonitoring 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.

Interventions

travel preventive consultation was performed by nurse

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Experimental arm: Nurse consultation Non interventional arm: the medical consultation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.At day 1Evaluated by a post-consultation memorization survey

Secondary

MeasureTime frameDescription
Quality score of the support consultation evaluating the memorization of Information by travelers.At day 1Evaluated by memorisation survey
Level of satisfaction of travelersAt day 1The level of satisfaction will be assessed by a visual scale.
The relevance of the choice of vaccinations proposed in relation to recommendationsAt day 1will be evaluated by a retrospective review
The relevance of the choice of prescribed anti-malarials in relation to recommendationAt day 1will be evaluated by a retrospective review

Countries

France

Contacts

Primary ContactDelphine LECLERC, Nurse
leclercd1@hotmail.fr01 48 95 53 42
Backup ContactNacira DARGHAL, PhD
nacira.darghal@aphp.fr01 48 95 74 73

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026