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

NCT ID: NCT03699501

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2021-07-09

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Questionnaires

Intervention Type OTHER

* 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)

Oral examination

Intervention Type PROCEDURE

* An evaluation of dental health using the CAO index
* An evaluation of oral hygiene with the IHO-S index

Voluntary patients

Questionnaires

Intervention Type OTHER

* 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)

Oral examination

Intervention Type PROCEDURE

* An evaluation of dental health using the CAO index
* An evaluation of oral hygiene with the IHO-S index

questionnaires (test-retest)

Intervention Type OTHER

SCOOHP and SOHP questionnaires

Interventions

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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)

Intervention Type OTHER

Oral examination

* An evaluation of dental health using the CAO index
* An evaluation of oral hygiene with the IHO-S index

Intervention Type PROCEDURE

questionnaires (test-retest)

SCOOHP and SOHP questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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DENIS 2018

Identifier Type: -

Identifier Source: org_study_id

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