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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by South West Sydney Local Health District
Sponsor:
Collaborator:
HammondCare
Information provided by (Responsible Party):
Mark Buhagiar, South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01583153
First received: April 19, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Other: Hospital Inpatient Rehabilitation
Other: Hybrid Home Programme (HO)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee

Resource links provided by NLM:


Further study details as provided by South West Sydney Local Health District:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ] [ Designated as safety issue: No ]
  • Knee range of motion [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ] [ Designated as safety issue: No ]
  • EQ5D [ Time Frame: Pre surgery; 10 weeks, six months and twelve months after surgery. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: June 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hospital Inpatient Rehabilitation (HI) 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.
Active Comparator: Hybrid Home Programme (HO) 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583153

Contacts
Contact: Mark A Buhagiar, MHM 0401 713 297 ext 68618 mark.buhagiar@sswahs.nsw.gov.au
Contact: Justine Naylor, PhD 0409 825 079 ext 83885 justine.naylor@sswahs.nsw.gov.au

Locations
Australia, New South Wales
Fairfield Hospital Recruiting
Sydney, New South Wales, Australia, 2176
Braeside Hospital Recruiting
Sydney, New South Wales, Australia, 2176
Sutherland Hospital Recruiting
Sydney, New South Wales, Australia, 2229
Sponsors and Collaborators
Mark Buhagiar
HammondCare
Investigators
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
  More Information

No publications provided by South West Sydney Local Health District

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Buhagiar, Manager of Allied Health, Principal Investigator, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01583153     History of Changes
Other Study ID Numbers: HIHO-1042554
Study First Received: April 19, 2012
Last Updated: July 29, 2014
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014