Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-01 @ 6:55 AM
Study NCT ID:
NCT03376750
Status:
UNKNOWN
Last Update Posted:
2017-12-18
First Post:
2017-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-rehabilitation Intervention for People Post Hip Fracture - Randomized Controlled Trial (RCT)
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'three-arm randomized control trail (RCT) including pre/post intervention and follow-up'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)', 'timeFrame': 'Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months', 'description': 'The COPM will be used for measuring performance and satisfaction with personally identified participation goals. Participants are asked to identify goals and then rate their performance and satisfaction with current status on a scale from 1 to 10, where 10 indicates optimal performance or satisfaction'}], 'secondaryOutcomes': [{'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months', 'description': 'The aim of the FIM is to monitor the recovery of functional ability by people undergoing rehabilitation. The FIM is comprised of 18 parameters, each rated on a scale of 1-7 (range = 18-126) according to the degree of assistance required to perform a specific activity'}, {'measure': 'The Geriatric Depression Scale (GDS)', 'timeFrame': 'Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months', 'description': 'The scale consists of 15 items; each item has two possible answers (yes or no). The highest possible score is 15, which indicates the most severe depressive state.'}, {'measure': '12-item MOS Short-Form Health Status Survey, Hebrew version', 'timeFrame': 'Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months', 'description': 'This generic HR-QoL instrument focuses on functional status. The questionnaire includes 12 items taken directly from the SF-36\\[73\\] which are used to calculate the Physical and Mental Component Summary. The first question measured by the SF-12 is an acceptable self-rated measure for general health'}, {'measure': 'The Zarit Caregiver Burden Interview', 'timeFrame': 'Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months', 'description': 'The ZBI includes 22 statements recorded in a 0-4 Likert scale (total score range 0 to 88, where higher scores mean higher burden), which rates the subjective component of burden'}, {'measure': 'Qualitative interview', 'timeFrame': 'post intervention, 10 weeks (T1)', 'description': 'Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telerehabilitation', 'occupational therapy', 'RCT', 'participation', 'quality of life', 'intervention', 'older adults'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '31109289', 'type': 'DERIVED', 'citation': 'Gilboa Y, Maeir T, Karni S, Eisenberg ME, Liebergall M, Schwartz I, Kaufman Y. Effectiveness of a tele-rehabilitation intervention to improve performance and reduce morbidity for people post hip fracture - study protocol for a randomized controlled trial. BMC Geriatr. 2019 May 20;19(1):135. doi: 10.1186/s12877-019-1141-z.'}]}, 'descriptionModule': {'briefSummary': 'Most surviving hip-fracture patients experience reduced mobility and lose their functional ability, which increases the risk of complications and rehospitalization. Post-discharge transitional programs to reduce readmissions have shown some success. Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. Considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers.\n\nThe purpose of this three armed randomized controlled trial is to investigate the effectiveness of an intervention program based on telerehabilitation on ADL, QOL, depression and burden on caregivers compared to face-to-face home visits and usual care of community-dwelling older adults after hip fracture.\n\n90 older people with hip fractures will be randomly assigned to a telerehabilitation group (N=30), face-to-face visits (N=30) and a control group.\n\nThe aim of the intervention is to improve the transition from rehabilitation units to community dwelling. It will include 10 videoconferencing/ face-to-face sessions from an occupational therapist in the presence of the primary caregiver. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOlder adults (age ≥60 years) post hip fracture - discharged from the inpatient rehabilitation unit of Herzog Hospital, Jerusalem, between January 2017 and December 2017.\n\nDischarge from rehabilitation to a non-institutionalized setting. broadband or Wi-Fi in their home and must be able to operate an iPad independently.\n\nFIM\\>90 at discharge. Has a designated caregiver (a close friend, family member, or support worker) aged over 18, and a Hebrew, English or Arabic speaker, who will agree to cooperate in the research\n\nExclusion Criteria:\n\nAphasia. cognitive impairment (Montreal Cognitive Assessment scores : MOCA\\<19 or MMSE\\<21).\n\ndegenerative neurological diagnoses. current major depressive or psychotic disorder. other acute or chronic health condition that will influence their ability to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03376750', 'briefTitle': 'Tele-rehabilitation Intervention for People Post Hip Fracture - Randomized Controlled Trial (RCT)', 'organization': {'class': 'OTHER', 'fullName': 'Herzog Hospital'}, 'officialTitle': 'Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HerzogH RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CO - OP via telerehabilitation + standard care', 'description': '10 CO-OP videoconferencing sessions from an occupational therapist . Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities.', 'interventionNames': ['Behavioral: CO - OP']}, {'type': 'EXPERIMENTAL', 'label': 'CO - OP via face to face + standard care', 'description': '10 CO - OP face to face sessions from an occupational therapist. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities.', 'interventionNames': ['Behavioral: CO - OP']}, {'type': 'NO_INTERVENTION', 'label': 'control group - standard care', 'description': 'standard care as given from public health service'}], 'interventions': [{'name': 'CO - OP', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Orientation to Occupational Performance'], 'description': 'CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance', 'armGroupLabels': ['CO - OP via face to face + standard care', 'CO - OP via telerehabilitation + standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yakir Kaufmam, MD', 'role': 'CONTACT', 'email': 'ykaufman@herzoghospital.org', 'phone': '+972545703130'}], 'facility': 'Herzog Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Yafit Gilboa, OTphD', 'role': 'CONTACT', 'email': 'yafitgilboa@yahoo.com', 'phone': '+972523362230'}, {'name': 'Talia Maeir, BOT', 'role': 'CONTACT', 'email': 'taliabengigi@gmail.com', 'phone': '+972547866338'}], 'overallOfficials': [{'name': 'Yafit Gilboa, OTphD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herzog Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}, {'name': 'Israel National Institute for Health Policy and Health Services Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yakir Kaufman', 'investigatorAffiliation': 'Herzog Hospital'}}}}