Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. (aCTIVE)
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Travel and Motion||Other: Nursing consultation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Experimental arm: Nurse consultation Non interventional arm: the medical consultation.|
|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|
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
- 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
- Quality score of the support consultation evaluating the memorization of Information by travelers. [ Time Frame: At day 1 ]Evaluated by memorisation survey
- Level of satisfaction of travelers [ Time Frame: At day 1 ]The level of satisfaction will be assessed by a visual scale.
- The relevance of the choice of vaccinations proposed in relation to recommendations [ Time Frame: At day 1 ]will be evaluated by a retrospective review
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03274180
|Contact: Delphine LECLERC, Nurse||01 48 95 53 firstname.lastname@example.org|
|Contact: Nacira DARGHAL, PhD||01 48 95 74 email@example.com|
|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 firstname.lastname@example.org|
|Contact: BOUCHAUD Olivier, Pr 01 48 95 54 21|
|Principal Investigator:||Delphine LECLERC, Nurse||Assistance Publique - Hôpitaux de Paris|