Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT02512094
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2015-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'panailao@gmail.com', 'title': 'Panai Laohaprasitiporn', 'organization': 'Faculty of Medicine Siriraj Hospital, Mahidol University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Elderly Hip Fracture', 'description': 'Age at least 50 years old Hip fractures within 2 weeks since injury', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score of the Barthel Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elderly Hip Fracture', 'description': 'Age at least 50 years old Hip fractures within 2 weeks since injury'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '14.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 month', 'description': 'Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).\n\nScore was reported as mean score of the Barthel Index.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were analyzed using descriptive statistics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elderly Hip Fracture', 'description': 'Age at least 50 years old Hip fractures within 2 weeks since injury'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Elderly Hip Fracture', 'description': 'Age at least 50 years old Hip fractures within 2 weeks since injury'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '77.3', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-19', 'studyFirstSubmitDate': '2015-07-26', 'resultsFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-19', 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of the Barthel Index', 'timeFrame': 'up to 1 month', 'description': 'Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).\n\nScore was reported as mean score of the Barthel Index.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Barthel index', 'Hip fracture', 'Validity', 'Reliability'], 'conditions': ['Hip Fracture', 'Femoral Neck Fracture', 'Intertrochanteric Fracture']}, 'descriptionModule': {'briefSummary': "Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care.\n\nBarthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.\n\nThe purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.", 'detailedDescription': "Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. This index had initially developed to evaluate the self-care of stroke patients which comprised of 10 questions about their basic activity of daily living. Barthel index had been well-accepted and widely used. Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients.\n\nHip fractures was usually occured in geriatric patients and there was a trend to increase every year. Most of the hip fractures were treated by surgical methods which needed postoperative rehabilitation programs to regain their functions. Less than half of the patients with hip fracture could regain their functions to preoperative level. Therefore, these patients needed a specific questionnaire to evaluate their functions. Barthel index is an uncomplicated questionnaire and can be used to evaluate treatment outcome of the patients.\n\nThe purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hip fractured patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 50 years old\n* Hip fractures within 2 weeks since injury\n\nExclusion Criteria:\n\n* incommunicable patients\n* pathological fractures\n* multiple fractures or multiple trauma\n* postoperative complications which change postoperative rehabilitation protocols'}, 'identificationModule': {'nctId': 'NCT02512094', 'briefTitle': 'Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients', 'orgStudyIdInfo': {'id': '236/2557(EC3)'}}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Aasis Unnanuntana, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}