Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT06889103
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Edinburgh Feeding Evaluation in Dementia (EdFed) Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edfed score', 'timeFrame': '1 year', 'description': 'Psychometric properties of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'EdFed', 'interobserver agreement'], 'conditions': ['Dementia', 'Feeding Difficulties', 'Reliability and Validity']}, 'referencesModule': {'references': [{'pmid': '26608444', 'type': 'BACKGROUND', 'citation': 'Bagnasco A, Watson R, Zanini M, Rosa F, Rocco G, Sasso L. Preliminary testing using Mokken scaling of an Italian translation of the Edinburgh Feeding Evaluation in Dementia (EdFED-I) scale. Appl Nurs Res. 2015 Nov;28(4):391-6. doi: 10.1016/j.apnr.2015.02.003. Epub 2015 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate the psychometric properties, including interobserver agreement, of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale, which was developed to assess eating difficulties in patients with dementia.', 'detailedDescription': 'Eating difficulties are common in dementia patients and can lead to malnutrition. Early detection and intervention of these difficulties is of great importance to minimise the negative effects. Therefore, a reliable and valid tool for assessing nutritional difficulties in dementia patients is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nursing home', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those over the age of 65,\n* Those diagnosed with dementia,\n* Patients who are able to weigh themselves (no lower extremity loss)\n\nExclusion Criteria:\n\n• (CDR\\<2)'}, 'identificationModule': {'nctId': 'NCT06889103', 'acronym': 'EdFed', 'briefTitle': 'Turkish Edinburgh Feeding Evaluation in Dementia (EdFed) Scale', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Psychometric Properties of the Turkish Version of the Edinburgh Feeding Evaluation in Dementia (EdFed) Scale', 'orgStudyIdInfo': {'id': 'Edfed scale'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observed', 'description': 'observation during eating', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'observation during eating', 'armGroupLabels': ['Observed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34394', 'city': 'Istanbul', 'state': 'Sıslı', 'country': 'Turkey (Türkiye)', 'facility': 'Darülaceze', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Büşra Kul, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ÜSKÜDAR ÜNİVERSİTESİ'}, {'name': 'Zelıha Tulek, Proffessor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'İstanbul University-Cerrahpaşa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It can be shared after publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Busra Kul', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}