Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-28 @ 4:51 AM
Study NCT ID:
NCT02730832
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2016-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-04-01', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of oral health by OHIP-14 scales', 'timeFrame': 'At inclusion'}, {'measure': 'Evaluation of quality of life by GOHAI scales', 'timeFrame': 'At inclusion'}, {'measure': 'Mc Nair Memory Questionnaire', 'timeFrame': 'At inclusion'}, {'measure': 'Evaluation of negative symptoms by scale', 'timeFrame': 'At inclusion'}, {'measure': 'Beck Depression Scale', 'timeFrame': 'At inclusion'}, {'measure': 'Evaluation of quality of life by S-Qol', 'timeFrame': 'At inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '30263228', 'type': 'DERIVED', 'citation': 'Frederic D, Corinne R, Matthieu R, Francesca SP, Stephanie TJ, Nathalie R. The Schizophrenia Oral Health Profile: Development and Feasibility. Transl Neurosci. 2018 Sep 22;9:123-131. doi: 10.1515/tnsci-2018-0019. eCollection 2018.'}, {'pmid': '29967693', 'type': 'DERIVED', 'citation': 'Siu-Paredes F, Rude N, Rat C, Reynaud M, Hamad M, Moussa-Badran S, Denis F. The Schizophrenia Coping Oral Health Profile. Development and Feasibility. Transl Neurosci. 2018 Jun 20;9:78-87. doi: 10.1515/tnsci-2018-0014. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.\n\nThe aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.\n\nTo do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of schizophrenia according to DSM V\n* Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years\n* Patients older than 18 years\n* Patients who have provided oral informed consent to take part in the study\n\nExclusion Criteria:\n\n* Patients who are psychiatrically unstable or delusional\n* Subjects on chemotherapy\n* Adults under guardianship\n* Patients without national health insurance cover'}, 'identificationModule': {'nctId': 'NCT02730832', 'acronym': 'QUALITY', 'briefTitle': 'Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'DENIS 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with schizophrenia', 'interventionNames': ['Other: Questionnaires completed at D0', 'Other: Questionnaires completed at D15 (test-retest for 30 patients)']}], 'interventions': [{'name': 'Questionnaires completed at D0', 'type': 'OTHER', 'armGroupLabels': ['Patients with schizophrenia']}, {'name': 'Questionnaires completed at D15 (test-retest for 30 patients)', 'type': 'OTHER', 'armGroupLabels': ['Patients with schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21033', 'city': 'Dijon', 'country': 'France', 'facility': 'CH La Chartreuse', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}