Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04047069
Status:
UNKNOWN
Last Update Posted:
2019-08-06
First Post:
2019-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Occupational Therapy Intervention in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-03', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-03', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life (with a quality of life scale specific to renal patients).', 'timeFrame': '1st day of study', 'description': 'The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale. The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as chronic renal failure.\n* between 18-65 years\n* undergoing HD treatment for at least 1 year\n\nExclusion Criteria:\n\n* Beck Depression Scale score of 17 or higher'}, 'identificationModule': {'nctId': 'NCT04047069', 'briefTitle': 'The Effect of Occupational Therapy Intervention in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Person-Centered Occupational Therapy Intervention on Occupational Performance and Quality of Life in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2019/257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Awareness Training', 'interventionNames': ['Behavioral: Awareness Training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '* Awareness Training\n* Person-Centered Occupational Therapy Intervention', 'interventionNames': ['Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention']}], 'interventions': [{'name': 'Awareness Training and Person-Centered Occupational Therapy Intervention', 'type': 'BEHAVIORAL', 'description': 'Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.', 'armGroupLabels': ['Intervention group']}, {'name': 'Awareness Training', 'type': 'BEHAVIORAL', 'description': 'Exp.\n\n* General information about HD\n* Approaches to Coping with HD Symptoms\n* Self care skills (eg hygiene)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Özgü İnal', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'Özgü İnal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Özgü İNAL', 'investigatorAffiliation': 'Hacettepe University'}}}}