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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03699501
Acronym
QUALITY BIS
Enrollment
108
Registered
2018-10-09
Start date
2019-04-15
Completion date
2021-07-09
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

OTHERQuestionnaires

* 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)

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

OTHERquestionnaires (test-retest)

SCOOHP and SOHP questionnaires

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026