Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 10:51 AM
Study NCT ID:
NCT04650360
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-24', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assesment by', 'timeFrame': '12 months', 'description': 'SF-12 Health Survey questionnaire which consists of two dimensions (Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12)) that measure eight health domains (PCS: general health, physical function, physical role, and body pain; MCS: social function emotional role, mental health, and vitality) divided into a summary score of the physical component. Each component can be scored from 0 (lowest health) to 100 (highest health).'}], 'secondaryOutcomes': [{'measure': 'Functional dependence (basic activities of daily living )assesment by', 'timeFrame': '12 months', 'description': 'Barthel scale for functional dependence analysis. A total score between 0 and 20 suggests total dependence, a total score between 21 and 60 suggests severe dependence, a total score between 61 and 90 suggests moderate dependence, a total score between 91 and 99 suggests mild dependence, and a total score of 100 suggests independence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. A total of 224 patients will be recruited, 102 patients from trauma units at the two University Hospitals of the province of Cáceres will receive the educational program, whereas 122 will not. Patients will consecutively included in either an intervention or a control group. Patients from the intervention group reill eceive an educational program during admission and the postoperative period. Patients from the control group will not receive any educational program. These patients will manage according to routine protocols.', 'detailedDescription': 'This study will be perform by Spanish nurses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients over 65 years of age\n* Diagnosis of hip fracture\n* Previous urgent surgical intervention for surgical fixation of the fracture\n\nExclusion criteria:\n\n* Cognitive impairment\n* Terminal situation'}, 'identificationModule': {'nctId': 'NCT04650360', 'briefTitle': 'Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University of Extremadura'}, 'officialTitle': 'Impact of a Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture', 'orgStudyIdInfo': {'id': 'PIEP_QLHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postoperative Intervention Educational Program', 'description': 'The intervention group will receive an educational program during admission. The health educational program will consist of a single training session offered by a nursing professional to each patient and caregiver. In each educational session, the following topics will be addressed: objectives for functional recovery (early mobilization, recovery of functional capacity lost prior to the fracture, etc.), mobilization exercises to start the day after the surgical procedure (lower limb exercise, respiratory physiotherapy, etc.), and tips to prevent future falls', 'interventionNames': ['Behavioral: Postoperative Intervention Educational Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The patients in the control group will not receive any educational program. These patients will be treated according to routine protocols'}], 'interventions': [{'name': 'Postoperative Intervention Educational Program', 'type': 'BEHAVIORAL', 'description': 'The health educational program consisted of a single training session offered by a nursing professional to each patient and caregiver. In each educational session, the following topics were addressed: objectives for functional recovery (early mobilization, recovery of functional capacity lost prior to the fracture, etc.), mobilization exercises to start the day after the surgical procedure (lower limb exercise, respiratory physiotherapy, etc.), and tips to prevent future falls. The educational session was implemented during the postoperative hospital stay, with an approximate duration of 30-45 min. The session ended with a summary of the content and comments from the patient and relative in order to ensure understanding of the program. Written information was provided on the aspects addressed in the session (brochures). These patients were treated according to routine protocols. All patients were monitored during admission, at 1 month, at 6 months, and at 1 year after the intervention', 'armGroupLabels': ['Postoperative Intervention Educational Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Cáceres', 'country': 'Spain', 'facility': 'Sergio Rico Martin', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}], 'overallOfficials': [{'name': 'Fidel Lopez Espuela, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nursing and Occupational Therapy College. University of Extremadura'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Extremadura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD. RN. Associate Professor', 'investigatorFullName': 'Dr. Fidel Lopez Espuela', 'investigatorAffiliation': 'University of Extremadura'}}}}