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The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement (HIHO)

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ClinicalTrials.gov Identifier: NCT01583153
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
HammondCare
Information provided by (Responsible Party):
Mark Buhagiar, South West Sydney Local Health District

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE June 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT) [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
Functional mobility is a composite of several factors targeted in rehabilitation programs after TKA such as lower limb strength, knee range of motion, and balance. Second, a functional outcome is more likely to be directly influenced by the intervention (rehabilitation), and the intervention aims to improve walking. Third, the 6MWT is highly reproducible within the individual. Fourth, it is likely to be less susceptible to misinterpretation and less culturally sensitive than patient-reported outcomes. Fifth, the test does not appear to suffer from the floor or ceiling effects associated with many patient-reported outcomes. Sixth, an observer-measured outcome is less likely to be influenced by a preference effect compared to a patient-reported outcome, and this is particularly important when the intervention under examination cannot be blinded from the recipient. Together, these attributes mean the results for our primary outcome should be readily translatable to any TKA cohort.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Gait speed (m/s) [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
Gait speed was chosen as the primary outcome as it is functionally relevant, is a composite of several factors targeted in rehabilitation programmes after TKR such as lower limb strength, knee range of motion, and balance, and is highly reproducible.
Change History Complete list of historical versions of study NCT01583153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2013)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
  • Knee range of motion [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
  • EQ5D [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
    The EQ5D is a standardised measure providing a simple, generic measure of health. It looks at mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and provides a simple descriptive profile and a single index value for health status.
  • Cost of surgery [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
    Itemised list of health service use, expenditure and days off work
  • Patient preference for therapy [ Time Frame: After consenting to participation and prior to randomisation ]
    Typical demographic and complication data (such as re-admission, re-operation, knee manipulation, death, venous thrombo-embolism, wound infection) will also be collected. As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR prior to randomisation. Question may be 'What is your preference for rehab? Is it home based, inpatient or no preference?
  • 15 metre walk test [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
  • Knee range of motion [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
  • EQ5D [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
  • Cost of surgery [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ]
    Itemised list of health service use, expenditure and days off work
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The HIHO Study: Hospital Inpatient vs Home Rehabilitation After Total Knee Replacement
Official Title  ICMJE Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
Brief Summary

Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode.

The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.

The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.

Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.

Superiority in these outcomes will be evident at six months after surgery.

Detailed Description

As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR, prior to randomisation.

Patients will be randomised once a hospital bed is available.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Other: Hospital Inpatient Rehabilitation
    Those allocated to HI will be admitted to the adjacent rehabilitation hospital, Braeside Rehabilitation Hospital, for 10 days. As per the private sector, HI participants will receive twice-daily supervised physiotherapy comprising 1-1.5 hr class-based exercises and 1-1.5 hr one-to-one therapy. Prior to discharge, participants will be familiarised with the home programme as described in second arm. All participants will be required to complete a diary detailing programme adherence, healthcare utilisation, and social costs relating to carer-burden. Participants will attend the group-based sessions as per HO below for monitoring and progression of programme. An additional FIM outcome measure will be taken for this arm on admission and discharge from the inpatient rehab unit.
  • Other: Hybrid Home Programme (HO)
    The HO will be based on what is standard care in the local health district and guidelines for exercise in the elderly and those with osteoarthritis. Approximately 2 weeks post-surgery, participants allocated to the HO will attend 1 group-based exercise session in the Physiotherapy Department (Fairfield Hospital) where the home programme will be rehearsed and exercises individualised as required due to co-morbidities. The programme comprises general aerobic components as well as general functional and muscle-specific exercises focused on restoring knee mobility, lower limb strength, and normal neuromuscular co-ordination and gait patterns. Participants will be able to return for 2-3 sessions over the 6-week period.
Study Arms  ICMJE
  • Active Comparator: Hospital Inpatient Rehabilitation (HI)
    Intervention: Other: Hospital Inpatient Rehabilitation
  • Active Comparator: Hybrid Home Programme (HO)
    Intervention: Other: Hybrid Home Programme (HO)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2016)
165
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
220
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive patients presenting for elective, primary, unilateral TKR at the Whitlam Joint Replacement Centre (Fairfield Hospital) will be screened for eligibility at the pre-admission clinic by the study Project Manager (PM).
  • primary diagnosis of OA

Exclusion Criteria:

  • predisposition for requiring prolonged inpatient supervision (eg requiring assistance with at least one personal activity of daily living or lack of social support)
  • inability to comprehend the study protocol.
  • catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583153
Other Study ID Numbers  ICMJE HIHO-1042554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Buhagiar, South West Sydney Local Health District
Study Sponsor  ICMJE Mark Buhagiar
Collaborators  ICMJE HammondCare
Investigators  ICMJE
Principal Investigator: Justine M Naylor, PhD BAppSc(Phty) SWSLHD
Principal Investigator: Ian A Harris, PhD, MBBS, M Epi SWSLHD
Principal Investigator: Friedbert Kohler HammondCare
Principal Investigator: Mark Buhagiar, MHM BAppSc(Phty) HammondCare
Principal Investigator: Rachael Wright, BAppSc(OccThpy) SWSLHD
Principal Investigator: Renee Fortunato, B.App.Sc.(Phys.) SWSLHD
Principal Investigator: Wei Xuan, MSc MAppStat PhD Ingham Institute
PRS Account South West Sydney Local Health District
Verification Date April 2016

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