Rehabilitation in the Home After Hip Fracture

NCT06980129 | Not Yet Recruiting DMC

• 1 other identifier: 2025_ETH00123
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Hip Fractures (ICD-10 72.01-72.2); Rehabilitation Program

Keywords

rehabilitation program; hip fracture

Outcome Measures

Primary Outcomes (1)

• De Morton Mobility Index (DEMMI)

  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.

  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 Outcomes (10)

• Length of Stay (LOS) - Total

  At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).

• Length of Stay (LOS) - Physical Ward Bed

  At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).

• Index Hip Pain

  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.

• EuroQol-5D-5L (EQ5D)

  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.

• Timed Up-and-Go Test (TUG Test)

  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.

Other Outcomes (5)

• Quality-Adjusted Life Years (QALYs)

  Assessments will be calculated at 6 weeks post-admission.

• Health Service Costs

  Health service costs will be assessed using data from each hospital's Finance Department, covering admission to the end of the allocated rehabilitation program (average 14 days post-rehab admission). Data will be available 8 to 12 weeks post-discharge.

• Participant and Carer Costs

  Assessments will occur weekly during the allocated rehabilitation program (up to average 14 days from rehabilitation admission), and at 6 weeks following initial hospital admission.

Study Arms (2)

Rehabilitation in the Home (RITH)

EXPERIMENTAL

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.

Other: Rehabilitation in the home

Usual Care Inpatient Rehabilitation (UCIR)

ACTIVE COMPARATOR

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: Usual care inpatient rehabilitation

Interventions

Rehabilitation in the home OTHER

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.

Rehabilitation in the Home (RITH)

Usual care inpatient rehabilitation OTHER

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.

Usual Care Inpatient Rehabilitation (UCIR)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (3)

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

Fairfield Hospital

Sydney, New South Wales, 2176, Australia

Location

Bankstown-Lidcombe Hospital

Sydney, New South Wales, 2200, Australia

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Thuy Anh Bui, BSC, GradCert Higher Ed, PhD

  South West Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thuy Anh Bui, BSC, GradCert Higher Ed, PhD

CONTACT

+61 02 8738 9254; ThuyAnh.Bui@health.nsw.gov.au

Justine Naylor, BAppSc (Physiotherapy), PhD

CONTACT

+61 02 8738 9257; Justine.Naylor@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor and statistician will be blinded to randomisation outcomes and will perform assessments on all participants from both arms. Assessments will be conducted at two time points: at the completion of the program (UCIR or RITH) and at six weeks following initial hospital admission. This blinding minimises potential bias in outcome evaluation and ensures the integrity, reliability, and objectivity of the trial's findings.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a pragmatic, multicentre, randomised, single-blinded, two-group parallel, non-inferiority trial with an embedded qualitative component. Participants will be recruited in parallel from two different hospitals, ensuring a diverse and representative sample.

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: De-identified Individual Participant Data (IPD) for this study will be available for sharing within 15 years after the study closure. Qualitative data will be securely stored for 5 years from the date of any publication, during which it will be available for sharing. After this period, the data will be destroyed in a confidential manner.
• Access Criteria: Access to Individual Participant Data (IPD) will be granted to authorised researchers who meet the following criteria: Researchers must provide a scientific rationale for requesting data, including the type of analysis to be conducted, with statistical methods subject to independent review approval. A data sharing proposal must be submitted, outlining the planned analyses and data required. A data sharing agreement must be signed, specifying the terms of use and confidentiality. Proposals and agreements will be submitted via email. Access will only be granted once these conditions are met.

Locations

AU (3)