SchizophreniaQUALITY BISNCT03699501
Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia
An observational study of Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Questionnaires, Oral examination and questionnaires (test-retest)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2019to 9 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaires, Oral examination, questionnaires (test-retest)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- 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 examinationProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Questionnaires; Procedure: Oral examination | |
| Voluntary patients | Not described Receives: Other: Questionnaires; Procedure: Oral examination; Other: questionnaires (test-retest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of scales (internal consistency)
Measured: through study completion, an average of 18 months
validity of scales (consistency of responses)
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Apr 2019
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699501
- Sponsor's protocol ID
- DENIS 2018
- Acronym
- QUALITY BIS
- Status last verified
- Apr 2022
- First submitted
- 5 Oct 2018
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT03699501
- Acronym / sponsor ID
- QUALITY BIS / DENIS 2018
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionnaires, Procedure: Oral examination |
| Voluntary patients | – | Other: Questionnaires, Procedure: Oral examination, Other: questionnaires (test-retest) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Patients, Voluntary patients |
| Oral examination* An evaluation of dental health using the CAO index * An evaluation of oral hygiene with the IHO-S index | Procedure or surgery | Patients, Voluntary patients |
| questionnaires (test-retest)SCOOHP and SOHP questionnaires | Other | Voluntary patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability of scales (internal consistency) (time frame: through study completion, an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.