Hip Fractures (ICD-10 72.01-72.2)RITH4HipsNCT06980129
Rehabilitation in the Home After Hip Fracture
A study testing Rehabilitation in the home in people with Hip Fractures (ICD-10 72.01-72.2) and Rehabilitation Program, run by South West Sydney Local Health District at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2), Rehabilitation Program
- What is being tested?
- Rehabilitation in the home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Jun 2025to 20 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites
Liverpool Hospital
Sydney, New South Wales, 2170
Professor Justine Naylor, PhD, +61 2 8738 9257, Justine.Naylor@health.nsw.gov.au
Dr Thuy Anh Bui, BSC, GradCert Higher Ed, PhD, +61 2 8738 9254, Thuyanh.Bui@health.nsw.gov.au
Fairfield Hospital
Sydney, New South Wales, 2176
Seema Radhakrishnan, MBBS,FAFRM,M Med,PhD,FULT, +61 2 9616 8111, seema.radhakrishnan@health.nsw.gov.au
Tai Tak Wan, MBBS, MRCP, FHKCP, FAFRM, DCH, +61 2 9728 9988, TaiTak.Wan@health.nsw.gov.au
Bankstown-Lidcombe Hospital
Sydney, New South Wales, 2200
Ishrat Jahan, MBBS, Dip Child Health, FRACGP, +61 400090362, ishrat.jahan@health.nsw.gov.au
Marie March, BAppScPhty, PhD, marie.march@health.nsw.gov.au
About this study
Official title: RITH4Hips - Rehabilitation in the Home After Hip Fracture
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:
Read more
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.
Read the detailed description
Study Aim This study aims to determine whether a multidisciplinary Rehabilitation in the Home (RITH) program for patients following low-trauma hip fracture (LTHF) is non-inferior to inpatient rehabilitation in terms of mobility during activities of daily living (ADL), assessed using the de Morton Mobility Index (DEMMI)
Study Design This is a pragmatic, multicentre, randomised, single-blinded, parallel-group, non-inferiority clinical trial with an embedded qualitative component.
As part of recruitment monitoring, reasons for declining participation will be recorded for individuals approached but not enrolled.
Hypotheses
The investigators hypothesise that compared to inpatient rehabilitation, the RITH program will be:
Non-inferior in terms of mobility recovery (DEMMI score within 2.9 points). Superior in reducing hospital bed days, with at least a 6-day reduction in physical ward stay.
Superior in improving health-related quality of life, walking ability, fear of falling, opioid consumption, and carer experience.
More cost-effective than usual care. Effective in reducing total length of stay (LOS), provided barriers to rapid transition to RITH are addressed.
Methods
Eligibility is determined perioperatively.
Inclusion criteria
- Adults aged ≥50 admitted to Liverpool or Bankstown hospitals with LTHF who:
- Undergo surgical management.
- Were living in the community pre-injury and plan to return home.
- Weight bear as tolerated post-surgery.
- Are deemed suitable for 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.
- Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice.
Once cleared for rehabilitation (typically 5-10 days post-surgery), participants will be randomised to:
Intervention Groups
Usual Care Inpatient Rehabilitation (UCIR): Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will collect information about carer visits and associated costs during the stay.
Rehabilitation in the Home (RITH): Participants will receive therapy at home from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will contact patients about carer-related costs during the program.
Follow-up Assessments:
After completing rehabilitation, researchers will visit participants at home (or in the clinic if preferred) shortly after discharge and again six weeks after their initial hospital admission to assess walking ability, daily activities, confidence, quality of life, pain, and post-surgery challenges. Researchers will also gather information on healthcare visits, costs, and new community services used. If participants have carers, the carers will be invited to complete a voluntary survey about carer experience. Medical records will also be reviewed to understand the care provided over the study period.
Qualitative study:
A purposive sample of patients and their carers who were randomised to the RITH group will be invited to participate in a one-on-one interview some weeks after completing rehabilitation. Additionally, an opportunistic sample of other stakeholders such as clinicians, healthcare managers, and insurers will be invited to participate. The embedded qualitative study seeks to gain insights into why the RITH program was or was not deemed effective for individual participants, as well as how the RITH program may be made more acceptable for future implementation.
Sample size calculation:
A sample of 220 participants (allowing for 7% loss to follow-up) is required to detect:
A 2.9-point between-group difference in DEMMI (non-inferiority margin: 6, SD: 8.9).
A 6-day reduction in hospital bed days (mean 25, SD 17, negative binomial parameter theta = 2.1) with 80% power (α = 0.05).
Analysis plan for primary outcome: The primary outcome will be analysed using an analysis of covariance (ANCOVA) with the 6-week DEMMI score as the dependent variable, and independent variables of group, timepoint, and an interaction between group and timepoint. The 6-week DEMMI will be examined using contrasts of the interaction.
Cost analysis: A cost-effectiveness analysis will be conducted alongside this trial, including both direct and indirect costs.
Analysis plan for qualitative study: Qualitative interviews will be analysed using the Rapid Assessment Process, combining deductive and inductive approaches for efficient thematic analysis.
- Being tested
- Rehabilitation in the home, Usual care inpatient rehabilitation
- Keywords
- rehabilitation program, hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation in the homeOther
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.
Usual care inpatient rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care inpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of days spent in the program, from acute admission until discharge from rehabilitation.
Measured: 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
Number of days spent in a physical ward bed in the hospital (including both acute and subacute locations).
Measured: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Index Hip Pain
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
Falls Efficacy Scale (FES)
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.
Measured: 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.
Zarit Carer Burden Interview (ZCBI)
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.
Measured: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Positive Aspects of Caregiving Scale (PACS)
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.
Measured: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Functional Independence Measure (FIM)
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.
Measured: 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.
Hospital-Acquired Complications (HACs)
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.
Measured: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuy Anh Bui, South West Sydney Local Health District
- Investigators
- Thuy Anh Bui, BSC, GradCert Higher Ed, PhD, Principal investigator, South West Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980129
- Sponsor's protocol ID
- 2025_ETH00123
- Other IDs
- 2025_ETH00123
- Acronym
- RITH4Hips
- Status last verified
- May 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Individual Participant Data (IPD) will be shared in accordance with the ICMJE policy. The study protocol will be shared as a publication. Specifically, de-identified data from this study will be securely stored in a REDCap database, accessible only to authorised researchers with approval from the South West Local Health District Human Research Ethics Committee. Paper-based records will be securely maintained, and no identifying information will be disclosed in any publications or reports, ensuring full compliance with privacy and ethical standards. Upon reasonable request, de-identified data from this study may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RITH4Hips - Rehabilitation in the Home After Hip Fracture
- ClinicalTrials.gov ID
- NCT06980129
- Acronym / sponsor ID
- RITH4Hips / 2025_ETH00123
- Keywords
- rehabilitation program, hip fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Aim This study aims to determine whether a multidisciplinary Rehabilitation in the Home (RITH) program for patients following low-trauma hip fracture (LTHF) is non-inferior to inpatient rehabilitation in terms of mobility during activities of daily living (ADL), assessed using the de Morton Mobility Index (DEMMI)
Study Design This is a pragmatic, multicentre, randomised, single-blinded, parallel-group, non-inferiority clinical trial with an embedded qualitative component.
As part of recruitment monitoring, reasons for declining participation will be recorded for individuals approached but not enrolled.
Hypotheses
The investigators hypothesise that compared to inpatient rehabilitation, the RITH program will be:
Non-inferior in terms of mobility recovery (DEMMI score within 2.9 points). Superior in reducing hospital bed days, with at least a 6-day reduction in physical ward stay.
Superior in improving health-related quality of life, walking ability, fear of falling, opioid consumption, and carer experience.
More cost-effective than usual care. Effective in reducing total length of stay (LOS), provided barriers to rapid transition to RITH are addressed.
Methods
Eligibility is determined perioperatively.
Inclusion criteria
- Adults aged ≥50 admitted to Liverpool or Bankstown hospitals with LTHF who:
- Undergo surgical management.
- Were living in the community pre-injury and plan to return home.
- Weight bear as tolerated post-surgery.
- Are deemed suitable for 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.
- Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice.
Once cleared for rehabilitation (typically 5-10 days post-surgery), participants will be randomised to:
Intervention Groups
Usual Care Inpatient Rehabilitation (UCIR): Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will collect information about carer visits and associated costs during the stay.
Rehabilitation in the Home (RITH): Participants will receive therapy at home from a multidisciplinary team. Discharge occurs when they achieve sufficient walking and functional ability, typically within 1-3 weeks. Researchers will contact patients about carer-related costs during the program.
Follow-up Assessments:
After completing rehabilitation, researchers will visit participants at home (or in the clinic if preferred) shortly after discharge and again six weeks after their initial hospital admission to assess walking ability, daily activities, confidence, quality of life, pain, and post-surgery challenges. Researchers will also gather information on healthcare visits, costs, and new community services used. If participants have carers, the carers will be invited to complete a voluntary survey about carer experience. Medical records will also be reviewed to understand the care provided over the study period.
Qualitative study:
A purposive sample of patients and their carers who were randomised to the RITH group will be invited to participate in a one-on-one interview some weeks after completing rehabilitation. Additionally, an opportunistic sample of other stakeholders such as clinicians, healthcare managers, and insurers will be invited to participate. The embedded qualitative study seeks to gain insights into why the RITH program was or was not deemed effective for individual participants, as well as how the RITH program may be made more acceptable for future implementation.
Sample size calculation:
A sample of 220 participants (allowing for 7% loss to follow-up) is required to detect:
A 2.9-point between-group difference in DEMMI (non-inferiority margin: 6, SD: 8.9).
A 6-day reduction in hospital bed days (mean 25, SD 17, negative binomial parameter theta = 2.1) with 80% power (α = 0.05).
Analysis plan for primary outcome: The primary outcome will be analysed using an analysis of covariance (ANCOVA) with the 6-week DEMMI score as the dependent variable, and independent variables of group, timepoint, and an interaction between group and timepoint. The 6-week DEMMI will be examined using contrasts of the interaction.
Cost analysis: A cost-effectiveness analysis will be conducted alongside this trial, including both direct and indirect costs.
Analysis plan for qualitative study: Qualitative interviews will be analysed using the Rapid Assessment Process, combining deductive and inductive approaches for efficient thematic analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation in the Home (RITH) | Experimental | Other: Rehabilitation in the homeParticipants 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. |
| Usual Care Inpatient Rehabilitation (UCIR) | Active comparator | Other: Usual care inpatient rehabilitationParticipants randomised to the usual care pathway. Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation in the homeParticipants 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 | Rehabilitation in the Home (RITH) |
| Usual care inpatient rehabilitationParticipants 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. | Other | Usual Care Inpatient Rehabilitation (UCIR) |
Primary outcome
De Morton Mobility Index (DEMMI)
Time frame: 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.
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.
10 secondary outcomes
Length of Stay (LOS) - Total
Time frame: 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
Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Index Hip Pain
Time frame: 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)
Time frame: 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)
Time frame: 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.
Falls Efficacy Scale (FES)
Time frame: 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.
Zarit Carer Burden Interview (ZCBI)
Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Positive Aspects of Caregiving Scale (PACS)
Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Functional Independence Measure (FIM)
Time frame: 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.
Hospital-Acquired Complications (HACs)
Time frame: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes. De-identified Individual Participant Data (IPD) will be shared in accordance with the ICMJE policy. The study protocol will be shared as a publication. Specifically, de-identified data from this study will be securely stored in a REDCap database, accessible only to authorised researchers with approval from the South West Local Health District Human Research Ethics Committee. Paper-based records will be securely maintained, and no identifying information will be disclosed in any publications or reports, ensuring full compliance with privacy and ethical standards. Upon reasonable request, de-identified data from this study may be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thuy Anh Bui, BSC, GradCert Higher Ed, PhD principal investigator
South West Sydney Local Health District
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in the home in people with Hip Fractures (ICD-10 72.01-72.2) and Rehabilitation Program, run by South West Sydney Local Health District at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thuy Anh Bui, BSC, GradCert Higher Ed, PhD (+61 02 8738 9254, ThuyAnh.Bui@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
De Morton Mobility Index (DEMMI) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.