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

NCT03699501 | Completed

• 1 other identifier: DENIS 2018
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients

Other: Questionnaires; Procedure: Oral examination

Voluntary patients

Other: Questionnaires; Procedure: Oral examination; Other: questionnaires (test-retest)

Interventions

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)

Patients; Voluntary patients

Oral examination PROCEDURE

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

Patients; Voluntary patients

questionnaires (test-retest) OTHER

SCOOHP and SOHP questionnaires

Voluntary patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Surveys and Questionnaires; Diagnosis, Oral

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Dentistry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: April 15, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

FR (1)