|- candidate number||24420|
|- NTR Number||NTR5879|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mei-2016|
|- Secondary IDs||NL54793.058.16 P16.056 METC Leiden University Medical Center|
|- Public Title||Morbidity in elderly travelers during a short-term stay abroad, a prospective cohort study|
|- Scientific Title||Morbidity in elderly travelers during a short-term stay abroad, a prospective cohort study|
|- ACRONYM||ELDEST study|
|- hypothesis||To determine frequency, duration and morbidity of (travel-related) health problems and/or exacerbations of underlying illnesses among Dutch travelers of 60 years and older visiting (sub)tropical destinations for a short-term stay to establish risk profiles characterized by vitality, health status and cognitive functioning.|
|- Healt Condition(s) or Problem(s) studied||Older adults, Travellers, Co-morbidity|
|- Inclusion criteria||A traveler is eligible for inclusion if all of the following criteria applied:|
- 60 years and older;
- Planned travel to (sub)tropical destinations
- Travel duration of five weeks (35 days) or less.
- Ability to complete the questionnaires and diary;
- Ability to speak and read Dutch fluently;
- Ability to sign the informed consent form.
|- Exclusion criteria||A traveler is not eligible for inclusion if one of the following criteria applied:|
- 59 years or younger;
- Travel to non (sub)tropical destinations;
- Travel duration longer than 5 weeks (>36 days);
- Inability to complete questionnaires and diary;
- Visit to travel clinic is less than two weeks before departure.
- Inability to speak or read Dutch;
- Incapacitated travelers (e.g. due to dementia);
- Absence of written informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jun-2016|
|- planned closingdate||31-jul-2017|
|- Target number of participants||500|
|- Interventions||No intervention (prospective observational cohort study)|
|- Primary outcome||The main endpoints of the primary objective are the occurrence, duration in days and morbidity of an acquired illness during travel and four weeks after return. The focus will be on different type of health complaints:|
- Genitourinary tract
Other endpoints of the objective are:
- Hand grip strength in kilograms before travel (vitality).
- Patient-reported health before, during and after travel (SF-36 and Charlson Comorbidity Index).
- Independence in activities of daily living (Katz-ADL).
- Cognitive functioning before travel (6CIT).
|- Secondary outcome||- Frequency of medical conditions before travel. |
- Frequency of medication use before travel.
- Number of medicines used before travel (e.g. polypharmacy).
- Frequency of infectious or non-infectious illnesses during travel or in the Netherlands until four weeks after return.
- Frequency of a new medical condition or an exacerbation of underlying medical condition during travel or in the Netherlands until four weeks after return.
- Percentage of medication adjustments during travel and four weeks or in the Netherlands until four weeks after return.
- Frequency of self-reported compliance with prescribed antimalarials during travel.
- Frequency of doctor visits abroad or in the Netherlands until four weeks after return.
- Frequency and duration of hospitalizations abroad or in the Netherlands until four weeks after return.
- Education level
- Weight (in kilograms)
- Length (in centimetres)
- Type of travel
- Type of accommodation
- Self-reported risk behaviour during travel
- Travel health insurance, covering medical costs and repatriation
|- Timepoints||- Before travel (grip strength, cognitive functioning, questionnaire 1, start diary)|
- During travel (diary)
- After travel (after 1 week questionnaire 2, filling in diary until 2 weeks after return)
- After travel (4 weeks after return questionnaire 3, some travelers 8 weeks after return questionnaire 4)
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jessica A. Vlot|
|- CONTACT for SCIENTIFIC QUERIES|| Jessica A. Vlot|
|- Sponsor/Initiator ||Travel Clinic, Leiden University Medical Center|
(Source(s) of Monetary or Material Support)
|International Society of Travel Medicine (ISTM research award), Travel Clinic, Leiden University Medical Center|
|- Publications||Not applicable|
|- Brief summary||People live longer in better health and are fit to travel at increasing ages. Various new risks can be faced during international travel due to age related health problems. Also comorbidities and accompanying polypharmacy can cause severe health problems, especially in elderly travelers. We therefore hypothesize that travelers of 60 years and older consulting pre-travel clinics and GP’s are not getting the tailored advice appropriate for their needs. |
|- Main changes (audit trail)|
|- RECORD||31-mei-2016 - 2-jul-2016|