Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04815434 |
| Other study ID # |
RNI 2020 FAULKS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 7, 2021 |
| Est. completion date |
May 27, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Oral health is the one of the commonest causes of health problems in the world, with almost
all individuals suffering from reduced oral health at some stage over their life span. As
such, oral health is a major public health issue and a major consumer of health spending.
Poor oral health results in pain, infection, structural degradation, functional restrictions
in chewing, swallowing and speech, change in facial appearance, social stigma, altered body
image, and reduced capacity to participate in social events, amongst others. Global problems
of human functioning, disability, health and environment in turn affect oral status in many
complex ways (for example, ability to maintain oral hygiene, nutritional restrictions,
neuromotor incapacity, dysphagia, ability to access and cooperate with treatment, etc).
Disability arises from a social environment that fails to enable everyone to access it
regardless of his or her impairment. Disabilities are thus socially created and not dependent
on the individual's type or location of impairment. There is currently very limited
qualitative research exploring perceptions of the mouth, or oral health within a social
environment, from the perspective of disabled adults. No universal, holistic, comprehensive
tool exists to describe oral health, the functional impact of oral health, and the
environmental factors influencing oral health within the biopsychosocial model. It has been
suggested that a framework for such an instrument may be supplied by the International
Classification of Functioning, Disability and Health (ICF: World Health Organisation, 2001)
This research seeks to address these gaps by describing perceptions of the mouth from the
perspective of adults with disabilities and complex health conditions, and by linking this
qualitative data to the ICF in order to assess the feasibility of using the ICF to
conceptualise oral health. Adults with disabilities and complex health conditions were chosen
for this ICF core set preliminary study as existing literature suggests that these
respondents would accumulate not only a high level of oral health need but also experience
high impact of functioning and environment on oral health.
Description:
A Case Record Form will be completed during the interview with the participant and/or their
carer. The form will record data relating to sociodemographics along with a subjective
appreciation of general health, oral health and mental health. Sociodemographic data will
include age, gender, level of education (age on completion / highest level), occupation,
income band and housing tenure (own house, parent's house, institution).
An investigator will undertake the interviews. Before starting data collection, the procedure
of the session will be explained and the aims of the study presented in lay terms. The
investigator will state that the individual has the possibility to refuse or withdraw his/her
participation at any time without consequences, and on simple request. Where possible, the
interviews will take place face to face, but may be undertaken over the telephone or by
video-conferencing if necessary. Audio recording will be undertaken during each interview.
During the interview, field notes will be taken in order to record elements of non-verbal
communication. The investigator will use a indicative topic guide covering six areas to
initiate a discussion. The investigator will use a indicative topic guide covering six areas
to initiate a discussion:
- How would you describe your health and your oral health?
- Do you have any health conditions which affect your mouth in any way?
- If so, which part of your mouth is affected and how?
- What is the impact of your oral health on your daily life?
- Do your living conditions or your social environment impact on your oral health in any
way?
- If you had to describe the impact of your oral health on daily life to someone what
would you say? Each question includes a series of prompts to assist participants in
answering the question.
It is anticipated that each interview will take around 60 minutes to complete.
