Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT04228068
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Stronger at Home Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Lower Extremity Functional Scale (LEFS)', 'timeFrame': 'Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)', 'description': 'The Lower Extremity Functional Scale is a patient-reported outcome measure that consists of 20 items. psychometric properties have been tested and established for different populations including patients after hip surgeries and lower extremity conditions. Score range is 0-80 with higher scores indicating better function.'}], 'secondaryOutcomes': [{'measure': 'The Short Physical Performance Battery (SPPB)', 'timeFrame': 'Change from baseline (before discharge), to 12 weeks weeks post discharge to home', 'description': 'The SPPB uses three tests to examine lower extremity physical performance: standing balance, gait speed, and chair-rising tests, and the total score is the sum of the three tests (0-12), with higher scores reflecting better physical function.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '36070134', 'type': 'DERIVED', 'citation': 'Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.'}]}, 'descriptionModule': {'briefSummary': 'Hip fracture is a major health problem facing older adults. Hip fractures result in higher mortality, morbidity, and costs than all other osteoporotic fractures combined. When returning home following hip fracture surgery, patients are at high risk of adverse outcomes (e.g., secondary fractures, institutionalisation, and death).\n\nObjectives: This study aims to finalize and pilot test a new program of care including a user-friendly toolkit containing a home-based physiotherapy exercise and pain management program to help community-dwelling older adults recover after hip fractures.\n\nMethods: This study will be two stages: First, finalizing the program. The investigators have created a self-explanatory toolkit that includes an illustrated exercise program based on a critical analysis of previous programs for hip fracture patients. The investigators will organize focus groups and conduct semi-structured interviews with patients, caregivers, policymakers, and healthcare providers to review the program and provide feedback.\n\nSecond, conducting a feasibility study. The investigators will pilot the program in a randomized trial with community-dwelling hip fracture patients and compare the intervention with conventional care.\n\nExpected Outcomes: While the number of hip fracture survivors is increasing, they are becoming frailer, and their functional recovery has not improved, making this study timely and relevant. With the current focus on helping older adults "age in place," the proposed project addresses a vital health system challenge: helping older hip fracture patients access proper rehabilitation, so they can stay independent in their homes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip fracture patients who are 65 years or older\n* being discharged to home or retirement home .\n\nExclusion Criteria:\n\n* participants with a terminal illness or significant contraindications preventing exercising (e.g. rapidly progressing neurological disease),\n* live away more than 30 km from the centre of the city, and\n* cannot sign the consent form and no proxy available to sign.'}, 'identificationModule': {'nctId': 'NCT04228068', 'briefTitle': 'The Stronger at Home Study', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'A Home-Based Rehabilitation Program for Patients With Hip Fracture: A Pilot Randomized Trial', 'orgStudyIdInfo': {'id': 'REH-721-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The exercise program will be for the first 12 weeks after returning home. The intervention will be provided after patients return home. Each patient will receive 7 home visits in total over the intervention period by a physiotherapist (PT) and/or a physiotherapy assistant (PTA). Participants in the intervention group will receive a copy of the Toolkit before discharge from the hospital, and the study coordinator will walk them through it and explain what should be expected during the intervention period.', 'interventionNames': ['Other: Rehabilitation Program', 'Other: Pain self management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional care', 'description': 'Usual care', 'interventionNames': ['Other: Conventional care']}], 'interventions': [{'name': 'Rehabilitation Program', 'type': 'OTHER', 'description': "PT visits (two visits): The first visit will happen within a week of discharge. During this visit, the PT will assess participants, tailor the program to their needs, and coach them in carrying out the exercises at home. The last visit will be 12 weeks after the first. During this visit, the PT will reassess the participants and make adjustments to the program. The participants will be encouraged to continue exercising beyond the 12 weeks.\n\nThe PTA will visit the participants' homes with the PT and will conduct additional solo visits every other week (i.e. 7 PTA visits in total, in 1st week and at 2, 4, 6, 8, 10, and 12 weeks). The PTA will facilitate and progress the exercise program as prescribed and directed by the PT and help in delivering the education component of the program.", 'armGroupLabels': ['Intervention']}, {'name': 'Pain self management', 'type': 'OTHER', 'description': "In addition to the exercise program, the intervention group will receive a pain self-management support tailored by the PT to the participants' needs.", 'armGroupLabels': ['Intervention']}, {'name': 'Conventional care', 'type': 'OTHER', 'description': 'The control group will receive the usual care provided by the healthcare system.', 'armGroupLabels': ['Conventional care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7M 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Providence Care Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Mohammad Auais, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Mohammad Auais, PhD', 'investigatorAffiliation': "Queen's University"}}}}