- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815434
Experience and Understanding of the Mouth, Oral Health and Function Amongst Adults With Disabilities and Complex Health Conditions. (FAULKS)
Experience and Understanding of the Mouth, Oral Health and Function Amongst
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Aura
-
Clermont-Ferrand, Aura, France, 63000
- UFR d'Odontologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults 18 years of age or over on day of data collection
- adults with self-defined disabilities and/or complex health conditions
- agreement to participate from the disabled adult or his/her carer
Exclusion Criteria:
- adults under 18 years of age
- adults without self-defined disabilities and/or complex health conditions
- refusal to participate from the disabled adult or his/her carer
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults with disabilities and complex health conditions
Interviews, experience of the mouth and oral health and function
|
Interviews will be conducted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interview "experiences of the mouth in adults with disabilities and complex health conditions"
Time Frame: Day 1
|
Interview will allow to gain understanding of the experiences of the mouth in adults with disabilities and complex health conditions
|
Day 1
|
Interview "Inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions."
Time Frame: Day 1
|
Interview will allow to gain understanding of the inter-relationships between the mouth, oral health, functioning and the social environment amongst adults with disabilities and complex health conditions.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interview "Ability of the ICF to contextualize experiences of oral health"
Time Frame: Day 1
|
Interview will allow to gain insight into the ability of the ICF to contextualise experiences of oral health
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2020 FAULKS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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