Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 5:33 PM
Study NCT ID:
NCT06536595
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Turkish Version of HAnDE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAnDE-T', 'timeFrame': 'Patients were asked to complete the HAnDE-T when they first came (baseline). After 1 week, they were asked to complete HAnDE-T for retest.', 'description': 'The Hand Scleroderma Lived Experience Scale. HAnDE is a PROM scale developed by Sibeoni et al. to assess the patient\'s current situation regarding his/her lived experience of global hand involvement. It consists of 16 questions that patients answer by giving a score between 0 and 4. While 0 means "I do not agree at all", 4 means "I completely agree." The total score of the HAnDE is determined by the sum of all answers given. The total score ranges from 0 to 64. Higher scores indicated higher hand involvement.'}], 'secondaryOutcomes': [{'measure': 'MHISS', 'timeFrame': 'Patients were asked to complete the MHISS when they first came (baseline).', 'description': 'The Mouth Handicap in Systemic Sclerosis Scale. MHISS is a scale developed by Mouthon et al. to quantify the handicap associated with mouth disability in patients with SSc. The MHISS consists of 12 questions to assess mouth-related disability. Patients responded to each question by giving a score of at least 0 and maximum 4. MHISS includes three domains: mouth opening, mouth dryness and esthetic concerns. The score that can be obtained from the scale ranges from 0 to 48, with higher scores indicating more limitations. The Turkish version of the MHISS was shown to be valid and reliable.'}, {'measure': 'SF-36', 'timeFrame': 'Patients were asked to complete the SF-36 when they first came (baseline).', 'description': '36-Item Short Form Survey. The SF-36 is a general quality of life assessment scale widely used to assess the quality of life. It was developed by the Rand Corporation in 1992. The SF-36 is a scale consisting of 8 sections and 36 items, including physical functionality, role limitations due to physical health problems, pain, social functionality, general health status, role limitations due to emotional problems, energy/vitality and mental health. The scale gives the total score for each subscale separately. The total score ranges from 0 to100. 0 indicates "poor health" status, 100 indicates "good health" status. The Turkish version of the SF-36 was shown to be valid and reliable.'}, {'measure': 'HAQ', 'timeFrame': 'Patients were asked to complete the HAQ when they first came (baseline).', 'description': 'Health Assessment Questionnaire. HAQ is an instrument developed to evaluate physical disability in 8 domains of the function: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activity. HAQ has been validated in patients with scleroderma. HAQ has 20 items in which patients evaluate their daily living activities by scoring between 0 and 3. The score of the test is determined by dividing the total scores given by the number of questions and varies between 0 and 3. The Turkish version of the HAQ was shown to be valid and reliable.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hand', 'reliability', 'scale', 'validation', 'scleroderma'], 'conditions': ['Scleroderma', 'Hand Rheumatism']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.', 'detailedDescription': "Objective: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.\n\nMethods: The HAnDE was cross-culturally adapted according to Beaton's guideline. Participants completed the Turkish version of HAnDE scale (HAnDE-T), The Mouth Handicap in Systemic Sclerosis Scale (MHISS), 36 Item Short Form Survey (SF-36), Health Assessment Questionnaire (HAQ). Internal consistency of the HAnDE-T questionnaire was evaluated by Cronbach's alpha coefficient. Convergent validity was tested using Pearson's correlation coefficient. The construct validity of the HAnDE-T questionnaire was assessed by factor analysis. The construct validity of the HAnDE-T was evaluated by correlating the scores between HAnDE-T and HAQ, SF-36 PCS, SF-36 MCS and MHISS scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'diagnosed with scleroderma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) being 18-65 years of age,\n* 2\\) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,\n* 3\\) being literate in Turkish,\n* 4\\) being agreed to participate in the research.\n\nExclusion Criteria:\n\n* 1\\) being in a psychological or cognitive disorders that would prevent to answer questions.'}, 'identificationModule': {'nctId': 'NCT06536595', 'briefTitle': 'Validity and Reliability of the Turkish Version of HAnDE', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Validity and Reliability of the Turkish Version of the Hand Scleroderma Lived Experience Scale', 'orgStudyIdInfo': {'id': '2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'got diagnosed scleroderma', 'interventionNames': ['Other: Scales']}], 'interventions': [{'name': 'Scales', 'type': 'OTHER', 'description': 'Participants were asked to complete the HAnDE-T, MHISS, SF-36 and HAQ when they first came. After 1 week, they were asked to complete HAnDE-T for re-test.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05000', 'city': 'Amasya', 'country': 'Turkey (Türkiye)', 'facility': 'Amasya University', 'geoPoint': {'lat': 40.65333, 'lon': 35.83306}}], 'overallOfficials': [{'name': 'Deran Oskay, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Gamze Pala', 'investigatorAffiliation': 'Gazi University'}}}}