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

NCT ID: NCT01583153

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hospital Inpatient Rehabilitation (HI)

Group Type ACTIVE_COMPARATOR

Hospital Inpatient Rehabilitation

Intervention Type OTHER

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.

Hybrid Home Programme (HO)

Group Type ACTIVE_COMPARATOR

Hybrid Home Programme (HO)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HammondCare

UNKNOWN

Sponsor Role collaborator

Mark Buhagiar

OTHER

Sponsor Role lead

Responsible Party

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Mark Buhagiar

Manager of Allied Health, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Justine M Naylor, PhD BAppSc(Phty)

Role: PRINCIPAL_INVESTIGATOR

SWSLHD

Ian A Harris, PhD, MBBS, M Epi

Role: PRINCIPAL_INVESTIGATOR

SWSLHD

Friedbert Kohler

Role: PRINCIPAL_INVESTIGATOR

HammondCare

Mark Buhagiar, MHM BAppSc(Phty)

Role: PRINCIPAL_INVESTIGATOR

HammondCare

Rachael Wright, BAppSc(OccThpy)

Role: PRINCIPAL_INVESTIGATOR

SWSLHD

Renee Fortunato, B.App.Sc.(Phys.)

Role: PRINCIPAL_INVESTIGATOR

SWSLHD

Wei Xuan, MSc MAppStat PhD

Role: PRINCIPAL_INVESTIGATOR

Ingham Institute

Locations

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Braeside Hospital

Sydney, New South Wales, Australia

Site Status

Fairfield Hospital

Sydney, New South Wales, Australia

Site Status

Sutherland Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R. Effect of Inpatient Rehabilitation vs a Monitored Home-Based Program on Mobility in Patients With Total Knee Arthroplasty: The HIHO Randomized Clinical Trial. JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224.

Reference Type DERIVED
PMID: 28291891 (View on PubMed)

Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright RJ, Fortunato R. Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial. Trials. 2013 Dec 17;14:432. doi: 10.1186/1745-6215-14-432.

Reference Type DERIVED
PMID: 24341348 (View on PubMed)

Other Identifiers

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HIHO-1042554

Identifier Type: -

Identifier Source: org_study_id

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