Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-04 @ 2:27 AM
Study NCT ID:
NCT03907566
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2019-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals', 'timeFrame': '3 months', 'description': 'This instrument is used to evaluate swallowing function. The test consists of 18 four points Likert-type items, organized assessing 3 scales: Safety, Efficacy, and Others. In most of the items, the Likert scale ranged from 1 = Never to 4 = Very often. The test score ranges from 18 (minimum) to 72 (maximum) points.'}], 'secondaryOutcomes': [{'measure': 'The Turkish version of the Eating Assessment Tool-10', 'timeFrame': '3 months', 'description': 'The Turkish version of the Eating Assessment Tool-10 is a self-reporting instrument with 10 questions. Total score ranges between 0 to 40. Higher scores indicate worse swallowing function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.', 'detailedDescription': "The purpose of this study is to test the reliability and validity of the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals among adult patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of the instrument will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals and Turkish Eating Assessment Tool."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with swallowing concerns', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate\n* Having swallowing problems\n\nExclusion Criteria:\n\n* Being under the age of 20 years, and above the age of 60 years\n* Not willing to participate\n* No swallowing problems'}, 'identificationModule': {'nctId': 'NCT03907566', 'briefTitle': 'The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Turkish Version of the Oropharyngeal Dysphagia Screening Test for Patients and Professionals', 'orgStudyIdInfo': {'id': 'Dysphagia screening'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with swallowing disorders', 'description': 'Swallowing function will be evaluated with the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals, and Turkish version of the Eating Assessment Tool.', 'interventionNames': ['Other: The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals']}], 'interventions': [{'name': 'The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals', 'type': 'OTHER', 'description': 'Swallowing function will be evaluated by the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals', 'armGroupLabels': ['Adult patients with swallowing disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacetttepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'SELEN SEREL ARSLAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'SELEN SEREL ARSLAN', 'investigatorAffiliation': 'Hacettepe University'}}}}