Travel and MotionaCTIVENCT03274180
Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine.
A study testing Nursing consultation in people with Travel and Motion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Travel and Motion
- What is being tested?
- Nursing consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne
Bobigny, 93000
Delphine LECLERC, Nurse, 01 48 95 53 42, leclercd1@hotmail.fr
BOUCHAUD Olivier, Pr, 01 48 95 54 21
About this study
Official title: A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine
A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover.
Read the 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.
- Conditions
- Travel and Motion
- Being tested
- Nursing consultation
- Keywords
- Travel consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing consultationOther
travel preventive consultation was performed by nurse
| Study group | Role | What they receive |
|---|---|---|
| Nursing consultation | Experimental | travel preventive consultation was performed by nurse Receives: Other: Nursing consultation |
| Medical consultation | No intervention | travel preventive consultation was performed by a doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.
Evaluated by a post-consultation memorization survey
Measured: At day 1
Secondary outcomes (4)
Quality score of the support consultation evaluating the memorization of Information by travelers.
Evaluated by memorisation survey
Measured: At day 1
Level of satisfaction of travelers
The level of satisfaction will be assessed by a visual scale.
Measured: At day 1
The relevance of the choice of vaccinations proposed in relation to recommendations
will be evaluated by a retrospective review
Measured: At day 1
The relevance of the choice of prescribed anti-malarials in relation to recommendation
will be evaluated by a retrospective review
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start25 Sep 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travel and MotionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental arm: Nurse consultation Non interventional arm: the medical consultation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine LECLERC, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274180
- Sponsor's protocol ID
- K100104J
- Acronym
- aCTIVE
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine
- ClinicalTrials.gov ID
- NCT03274180
- Acronym / sponsor ID
- aCTIVE / K100104J
- Conditions
- Travel and Motion
- Keywords
- Travel consultation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Experimental arm: Nurse consultation Non interventional arm: the medical consultation.
| Arm | Type | Receives |
|---|---|---|
| Nursing consultation | Experimental | Other: Nursing consultationtravel preventive consultation was performed by nurse |
| Medical consultation | No intervention | –travel preventive consultation was performed by a doctor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)
Key exclusion criteria (6 listed)
- Children and pregnant women,
- Travellers (man and woman) with co-morbidity factors as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing consultationtravel preventive consultation was performed by nurse | Other | Nursing consultation |
Primary outcome
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
4 secondary outcomes
Quality score of the support consultation evaluating the memorization of Information by travelers.
Time frame: At day 1
Level of satisfaction of travelers
Time frame: At day 1
The relevance of the choice of vaccinations proposed in relation to recommendations
Time frame: At day 1
The relevance of the choice of prescribed anti-malarials in relation to recommendation
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine LECLERC, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing consultation in people with Travel and Motion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine LECLERC, Nurse (01 48 95 53 42, leclercd1@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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. (time frame: At day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.