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

Completed

• Conditions: Schizophrenia
• Interventions: Other: Questionnaires; Procedure: Oral examination; Other: questionnaires (test-retest)

• Registration Number: NCT03699501
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2019-04-15
• Primary Completion: 2021-07-09
• Study Completion: 2021-07-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Oral examination	-
Patients	Questionnaires	-
Voluntary patients	Questionnaires	-
Voluntary patients	questionnaires (test-retest)	-
Voluntary patients	Oral examination	-

Primary Outcome Measures

Name	Time	Method
reliability of scales (internal consistency)	through study completion, an average of 18 months
validity of scales (consistency of responses)	through study completion, an average of 18 months

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France