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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06980129
Registration number
NCT06980129
Ethics application status
Date submitted
13/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Titles & IDs
Public title
Rehabilitation in the Home After Hip Fracture
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Scientific title
RITH4Hips - Rehabilitation in the Home After Hip Fracture
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Secondary ID [1]
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2025_ETH00123
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Secondary ID [2]
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2025_ETH00123
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Universal Trial Number (UTN)
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Trial acronym
RITH4Hips
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Fractures (ICD-10 72.01-72.2)
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Rehabilitation Program
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Rehabilitation in the home
Other interventions - Usual care inpatient rehabilitation
Experimental: Rehabilitation in the Home (RITH) - Participants randomised to the experimental pathway. Participants will receive home-based therapy from a multidisciplinary (MDT) team, including physiotherapists, occupational therapists, social workers, dieticians, medical practitioners, psychologists, and pharmacists.
Active comparator: Usual Care Inpatient Rehabilitation (UCIR) - Participants randomised to the usual care pathway. Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team.
Other interventions: Rehabilitation in the home
Participants will receive home-based therapy from a MDT team, including physiotherapists, occupational therapists, social workers, dietitians, medical practitioners, psychologists, and pharmacists. Participants will be transferred to RITH once they achieve a level of mobility (+/- assistance) that enables them to manage at home. As per usual care, the disciplines required, frequency of visits, duration of visits, and duration of rehabilitation will be based on the patient's specific needs. There will be weekly MDT conferences to discuss patient progress led by medical staff. Telehealth care may be incorporated into the RITH program, subject to patient preference and provider availability. If the participant deteriorates during the RITH program, the escalation plan mandated by the LHD HITH Department will be followed to ensure appropriate care is provided. As for UCIR, discharge occurs when patients achieve sufficient walking and functional ability with available assistance.
Other interventions: Usual care inpatient rehabilitation
Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a MDT team. Discharge occurs when patients achieve sufficient walking and functional ability with available assistance, typically within 1-3 weeks, though this varies.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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De Morton Mobility Index (DEMMI)
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Assessment method [1]
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The De Morton Mobility Index is a mobility outcome measure specifically designed for an older population. The DEMMI assesses 15 tasks which are associated with activities of daily living such as bed mobility and sit-to-stand transitions. The DEMMI is scored between 0 - 100, where 0 represents no mobility and 100 represents full mobility. The Minimal Clinically Important Difference (MCID) for the DEMMI is estimated to be approximately 6 points, representing the smallest change necessary to reflect a clinically meaningful improvement in mobility.
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Timepoint [1]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.
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Secondary outcome [1]
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Length of Stay (LOS) - Total
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Assessment method [1]
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Number of days spent in the program, from acute admission until discharge from rehabilitation.
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Timepoint [1]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
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Secondary outcome [2]
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Length of Stay (LOS) - Physical Ward Bed
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Assessment method [2]
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Number of days spent in a physical ward bed in the hospital (including both acute and subacute locations).
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Timepoint [2]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
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Secondary outcome [3]
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Index Hip Pain
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Assessment method [3]
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Hip pain at rest, on movement, and maximum. Score is a numerical rating from 0 - 10, where 0 is no pain and 10 is the worst pain imaginable.
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Timepoint [3]
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Assessments will occur at baseline (within 24 hours prior to randomisation), daily during the allocated rehabilitation program (an average of 14 days from admission to rehabilitation), and at 6 weeks following initial hospital admission.
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Secondary outcome [4]
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EuroQol-5D-5L (EQ5D)
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Assessment method [4]
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The EuroQol-5D-5L is a questionnaire used to measure patient's health-related quality of life. It assesses 5 domains related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression and provides a score between 1 - 5 for each domain where 1 means no problems, and 5 means extreme problems.
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Timepoint [4]
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Assessments will be conducted at baseline (within 24 hours prior to randomisation), at 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation), and at 6 weeks post-admission.
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Secondary outcome [5]
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Timed Up-and-Go Test (TUG Test)
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Assessment method [5]
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The Timed Up-and-Go Test measures the time required for a patient to stand from a seated position and walk three meters at a comfortable pace using any required mobility aids, before returning to a seated position. The TUG Test is a good indicator of overall mobility and fall risk, however, it will only be used on patients deemed capable of safely conducting this test.
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Timepoint [5]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.
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Secondary outcome [6]
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Falls Efficacy Scale (FES)
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Assessment method [6]
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The Falls Efficacy Scale is a 10-item questionnaire used to assess a patient's fear of falling during various activities of daily living. Each item is scored between 1 - 10, where 1 means very confident with this activity, and 10 means not confident at all with this activity. Higher scores indicate a higher fear of falling.
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Timepoint [6]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.
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Secondary outcome [7]
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Zarit Carer Burden Interview (ZCBI)
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Assessment method [7]
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The short-form Zarit Carer Burden Interview assesses the physical, emotional, social, and financial burden associated with being a caregiver. Each item is assigned a score from 0 - 4, where 0 means never and 4 means nearly always. Higher total scores are associated with increased carer burden.
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Timepoint [7]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
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Secondary outcome [8]
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Positive Aspects of Caregiving Scale (PACS)
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Assessment method [8]
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The Positive Aspects of Caregiving Scale assesses the perceived benefits experienced by caregivers as a result of their role. The PACS is designed to balance to conventionally negatively-skewed burden assessments by instead focusing on domains related to personal growth and relationship satisfaction. The PACS uses a scale of 1 - 5 for each item where 1 means strongly disagree and 5 means strongly agree. Higher total scores are associated with more positive caregiving experiences.
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Timepoint [8]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
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Secondary outcome [9]
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Functional Independence Measure (FIM)
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Assessment method [9]
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The Functional Independence Measure (FIM) is a routinely used outcome measure in inpatient rehabilitation to assess a patient's level of disability and need for assistance with activities of daily living. It consists of 18 items, each scored on a 1-7 scale, where 1 indicates total assistance required and 7 signifies complete independence. Higher total scores reflect greater overall functional independence.
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Timepoint [9]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.
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Secondary outcome [10]
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Hospital-Acquired Complications (HACs)
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Assessment method [10]
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The rate and types of Hospital-Acquired Complications (HACs) will be recorded at the end of the program, with definitions aligned to the Australian Commission on Safety and Quality in Health Care (https://www.safetyandquality.gov.au/our-work/indicators-measurement-and-reporting/hospital-acquired-complications-hacs). Additionally, regular safety monitoring of adverse events will be conducted throughout the program.
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Timepoint [10]
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At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
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Eligibility
Key inclusion criteria
* Community-dwelling adults ages = 50 years presenting to Liverpool hospital or Bankstown-Lidcombe hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management
* Anticipated to return to community (private) residence
* Permitted to weight-bear as tolerated post-surgery
* Suitable for inpatient rehabilitation (i.e., requires multidisciplinary rehabilitation, is considered cognitively suitable by the MDT to participate in the rehabilitation program being examined, and would otherwise be admitted to inpatient rehabilitation)
* The presence of a carer, if required for mobility or function, is necessary at the time of transfer to the community. The carer must be prepared to manage the patient within 3 days post-randomisation. This time frame is considered necessary as carers will not be able to complete all required preparations before randomisation, and allowing an extended preparation period could bias the length of physical ward bed stay for the RITH group
* Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Presence of a concomitant condition that precludes actively participating in a rehabilitation program at home
* Residential location outside the Bankstown-Canterbury, Liverpool, and Fairfield Local Government Areas
* Active end-of-life management or palliative care
* Previously participated in the HITH4Hips or RITH4Hips trials
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
20/09/2027
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Liverpool Hospital - Sydney
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Recruitment hospital [2]
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Fairfield Hospital - Sydney
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Recruitment hospital [3]
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Bankstown-Lidcombe Hospital - Sydney
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Recruitment postcode(s) [1]
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2170 - Sydney
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Recruitment postcode(s) [2]
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2176 - Sydney
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Recruitment postcode(s) [3]
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2200 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation. Objectives: The main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management. Methods: This study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital. Expected Outcomes: The investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.
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Trial website
https://clinicaltrials.gov/study/NCT06980129
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thuy Anh Bui, BSC, GradCert Higher Ed, PhD
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Address
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South West Sydney Local Health District
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Thuy Anh Bui, BSC, GradCert Higher Ed, PhD
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Phone
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+61 02 8738 9254
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06980129
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