Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-06 @ 11:29 AM
Study NCT ID:
NCT03927092
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reliability of the questionnaire', 'timeFrame': '1 day', 'description': "Internal consistency was evaluated by the coefficient alpha (α) or Cronbach's coefficient, and if the Cronbach's coefficient value was greater than 0.7, it was considered as an acceptable internal consistency"}], 'secondaryOutcomes': [{'measure': 'Number of correct answers', 'timeFrame': '1 day', 'description': 'To assess the distribution of correct and false answers and the levels of significance, Chi-square test was used. To compare the two questionnaires answered by the same patient before and after the seminar Wilcoxon signed-rank test was used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'surveys and questionnaires', 'diagnostic self evaluation'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19995834', 'type': 'BACKGROUND', 'citation': 'Giordano A, Uccelli MM, Pucci E, Martinelli V, Borreani C, Lugaresi A, Trojano M, Granella F, Confalonieri P, Radice D, Solari A; SIMS-Trial group. The Multiple Sclerosis Knowledge Questionnaire: a self-administered instrument for recently diagnosed patients. Mult Scler. 2010 Jan;16(1):100-11. doi: 10.1177/1352458509352865. Epub 2009 Dec 7.'}]}, 'descriptionModule': {'briefSummary': "Multiple Sclerosis Knowledge Questionnaire (MSKQ) is a 25-item self administered questionnaire assessing a patient's level of knowledge regarding multiple sclerosis (MS). Turkish translation of the questionnaire was prepared and participants in the annual patient education seminar in the investigators' university hospital were asked to answer these questions before and after the seminar.Their results were analysed to assess their level of knowledge about their disease.", 'detailedDescription': "Multiple sclerosis knowledge questionnaire was developed in Italy (1) and was reported to be useful in measuring patients' level of knowledge about their disease. The English version of the questionnaire was translated into Turkish by three physicians than back translated into English by two separate linguists. Initially 5 MS patients were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. Their feedback was used to give the questionnaire its final shape. For the validation stage, patients that were diagnosed as having MS and who attended the annual MS patient education seminar were enrolled into the study. They answered the questions twice, before and after the seminar. Their answers were analysed to measure their level of knowledge about their disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as having multiple sclerosis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed as having Multiple Sclerosis\n* Attends the annual patient education seminar at the investigators' university hospital\n* Older than 18 years of age\n* Can read and write\n\nExclusion Criteria:\n\n* Does not accept to answer the questionnaire\n* Unable to answer the questions due to a cognitive impairment"}, 'identificationModule': {'nctId': 'NCT03927092', 'briefTitle': 'Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Reliability and Validity of the Turkish Version of the Multiple Sclerosis Knowledge Questionnaire', 'orgStudyIdInfo': {'id': '16-4.1/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis patients', 'description': "Patients that attended an annual patient education seminar at the investigators' university hospital were asked to fill out the Turkish version of the Multiple Sclerosis Knowledge Questionnaire", 'interventionNames': ['Other: Multiple Sclerosis Knowledge Questionnaire']}], 'interventions': [{'name': 'Multiple Sclerosis Knowledge Questionnaire', 'type': 'OTHER', 'description': 'A 25-item self-administered questionnaire', 'armGroupLabels': ['Multiple Sclerosis patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ece Cinar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}, {'name': 'Yesim Akkoc, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University School of Medicine'}, {'name': 'Funda Calis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}, {'name': 'Musa Baklaci, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}, {'name': 'Ozgul Ekmekci, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}, {'name': 'Ayse N Yuceyar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ece Cinar', 'investigatorAffiliation': 'Ege University'}}}}