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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

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

Procedure

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

questionnaires (test-retest)

Other

SCOOHP and SOHP questionnaires

Primary outcomes

reliability of scales (internal consistency)

Time frame: through study completion, an average of 18 months
validity of scales (consistency of responses)

Time frame: through study completion, an average of 18 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: QUALITY BIS

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 9, 2018
Registry last updated: Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed