Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia

Schizophrenia Clinical Trial

— QUALITY BIS  

Official title:

Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699501
• Other study ID #: DENIS 2018
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: July 9, 2021

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases. To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world. The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP). However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult person,
• Patients for whom a diagnosis of schizophrenia is defined according to ICD 10
• Person who has given his or her oral agreement to participate in the study, with the agreement of the tutor in the context of a tutorship,
• Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis,
• Fluent use of the French language.

Exclusion Criteria:

• Psychiatrically unstable and delusional patients.
• Patients with cognitive abilities too impaired to participate in the study
• Individuals with no natural teeth
• Pregnant or breastfeeding women
• Patients not affiliated to the national health insurance system.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Questionnaires
A validated oral health-related quality of life self-assessment questionnaire: the GOHAI A validated oral health-related quality of life self-assessment questionnaire to be validated: SOHP A validated depression scale: the Beck scale A self-assessment questionnaire for oral health coping to be validated: the SCOOHP A validated self-assessment questionnaire for coping: The Brief cope)

Procedure:
• Oral examination
An evaluation of dental health using the CAO index An evaluation of oral hygiene with the IHO-S index

Other:
• questionnaires (test-retest)
SCOOHP and SOHP questionnaires

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reliability of scales (internal consistency)		through study completion, an average of 18 months
Primary	validity of scales (consistency of responses)		through study completion, an average of 18 months