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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

Titles & IDs
Public title
Rehabilitation in the Home After Hip Fracture
Scientific title
RITH4Hips - Rehabilitation in the Home After Hip Fracture
Secondary ID [1] 0 0
2025_ETH00123
Secondary ID [2] 0 0
2025_ETH00123
Universal Trial Number (UTN)
Trial acronym
RITH4Hips
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fractures (ICD-10 72.01-72.2) 0 0
Rehabilitation Program 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
De Morton Mobility Index (DEMMI)
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Length of Stay (LOS) - Total
Timepoint [1] 0 0
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Secondary outcome [2] 0 0
Length of Stay (LOS) - Physical Ward Bed
Timepoint [2] 0 0
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Secondary outcome [3] 0 0
Index Hip Pain
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
EuroQol-5D-5L (EQ5D)
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Timed Up-and-Go Test (TUG Test)
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Falls Efficacy Scale (FES)
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Zarit Carer Burden Interview (ZCBI)
Timepoint [7] 0 0
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Secondary outcome [8] 0 0
Positive Aspects of Caregiving Scale (PACS)
Timepoint [8] 0 0
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Secondary outcome [9] 0 0
Functional Independence Measure (FIM)
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Hospital-Acquired Complications (HACs)
Timepoint [10] 0 0
At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).

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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/09/2027
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
Fairfield Hospital - Sydney
Recruitment hospital [3] 0 0
Bankstown-Lidcombe Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2170 - Sydney
Recruitment postcode(s) [2] 0 0
2176 - Sydney
Recruitment postcode(s) [3] 0 0
2200 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thuy Anh Bui, BSC, GradCert Higher Ed, PhD
Address 0 0
South West Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thuy Anh Bui, BSC, GradCert Higher Ed, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 02 8738 9254
Fax 0 0
Email 0 0
[email protected]
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