Study into the prevalence of Tinea Pedis in intellectually disabled people who receive care from one of four care providers in The Netherlands, either living in the community or in a centralised location. Study into the prevalence of the different…
ID
Source
Brief title
Condition
- Fungal infectious disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of Tinea Pedis in percentage in our study population, including 95%
confidence intervals. Prevalence of the pathogens (fungi) that cause Tinea
Pedis identified in our population in percentage of the established cases,
including 95% confidence intervals. Calculating odds ratios for five risk
factors contributing to Tinea Pedis in the study population, including 95%
confidence intervals.
Secondary outcome
Niet van toepassing.
Background summary
Tinea Pedis is a fungal infection (dermatomycosis) of the feet, with high
prevalence in the normal population. At least 10 percent of the population will
suffer from Tinea Pedis at least once in their life (life time prevalence).
Literature study reveals that the prevalence of Tinea Pedis in intellectually
disabled people has not been studied yet. Which risk factors contribute to the
development of Tinea Pedis in this population is also as yet unknown.
Study objective
Study into the prevalence of Tinea Pedis in intellectually disabled people who
receive care from one of four care providers in The Netherlands, either living
in the community or in a centralised location. Study into the prevalence of the
different pathogens (fungi) that cause Tinea Pedis identified in our study
population. Study into five risk factors that contribute to the development of
Tinea Pedis in the study population.
Study design
Our study is a non-invasive observational, cross-sectional prevalence study in
people with mild to profound intellectual disability. Participants will be semi
randomly selected for inclusion into the study. The number of participants to
be included into our study has been calculated at 690, in order to make
statistically significant statements on the prevalence of Tinea Pedis and five
risk factors in our study population. The presence of Tinea Pedis will be
established by a physical examination and inspection of the feet of the
participants. If the presence of Tinea Pedis is suspected then a culture will
be performed. Risk factors will be examined through a questionnaire that will
be either filled out by the participants themselves, their relatives or
supervisors, completed by additional data from their medical files. All data
will be processed anonymously and cannot be traced to any particular
participant.
Study burden and risks
The physical examination will at most take ten minutes per participant. A
physical burden can be the removal of socks and shoes (if not already taken off
beforehand) and the inspection of the feet by the participating physicians,
including touching the feet and possible manipulation of the feet in order to
inspect the entire foot. When presence of Tinea Pedis is suspected then either
a swab of the area will be made or loose skin will be collected using a pair of
tweezers. The risk of any adverse physical reactions in our study is
negligible. The risk of any adverse psychological reactions is negligible. If
participants show resistance during the physical examination, then the
examination will be aborted and a second attempt will be made at a later date.
If during the second attempt the participant still exhibits resistance, then
the examination will be aborted for good and the participant will no longer be
included into our study. The definition of resistance will be according to the
definition provided by the document *Verzet bij mensen met een verstandelijke
handicap in het kader van de Wet medisch-wetenschappelijk onderzoek met mensen,
gedragscode voor artsen bij beoordeling van verzet bij mensen met een
verstandelijke handicap* (Resistance in people with intellectual disability as
outlined in the Act Medical Scientific Study in people, code of behaviour for
physicians when evaluating resistance in people with intellectual disability).
Group relatedness is applicable because our study is into the prevalence of
Tinea Pedis in people with intellectual disability and cannot be performed in
people with normal intellectual ability.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
intellectual disability
age 18 or over
living with and receiving care from one of the participating careproviders
Exclusion criteria
age under 18
No consent from participant or legal guardian
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31538.078.10 |