Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT02802358
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2016-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007103', 'term': 'Immobilization'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1824}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaires to measure change in the functionality of the elderly', 'timeFrame': 'Before and 6 months after the fall'}], 'secondaryOutcomes': [{'measure': 'Questionnaire to measure change in the health-related quality of life of the elderly', 'timeFrame': 'Before and 6 months after the fall'}, {'measure': 'Questionnaire to measure change in the performance of activities of daily living', 'timeFrame': 'Before and 6 months after the fall'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Falls', 'Functionality'], 'conditions': ['Elderly', 'Wrist Fracture', 'Hip Fracture']}, 'descriptionModule': {'briefSummary': "Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. To compare the functional dependency and health related quality of life (HRQoL) presented by the patients immediately and six months after a fall.\n\nMethodology: Prospective Cohort study. One hundred and fifty patients suffering from each type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected to be collected. Data will be collected from ED and hospital clinical records and by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL (SF-36) requesting information on status before the fall, immediately and six months later. In addition to this, data referred to care provided to the patients by traumatologist, rehabilitation or primary care provider as well as social services in their homes after the index episode will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 65 or older with a hip or wrist fracture due to a fall who attended the ED of the participating hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hip or wrist fracture due to an accidental fall.\n* Providing informed consent.\n\nExclusion Criteria:\n\n* Physical or psychological impairments that would prevent patients from properly completing the questionnaires.\n* Syncope.\n* No acceptance for taking part in the study.'}, 'identificationModule': {'nctId': 'NCT02802358', 'briefTitle': 'Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Galdakao-Usansolo'}, 'orgStudyIdInfo': {'id': 'PI08/90417'}, 'secondaryIdInfos': [{'id': '2008111016', 'type': 'OTHER_GRANT', 'domain': 'Department of Health of the Basque Country'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hip fracture', 'description': 'Patients with a hip fracture due to an accidental fall', 'interventionNames': ['Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)']}, {'label': 'Wrist fracture', 'description': 'Patients with a wrist fracture due to an accidental fall', 'interventionNames': ['Procedure: Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)']}], 'interventions': [{'name': 'Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)', 'type': 'PROCEDURE', 'armGroupLabels': ['Hip fracture', 'Wrist fracture']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Galdakao-Usansolo', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'JOSE M QUINTANA-LOPEZ, MD PhD', 'investigatorAffiliation': 'Hospital Galdakao-Usansolo'}}}}