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Trial registered on ANZCTR


Registration number
ACTRN12617000848303
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
8/06/2017
Date last updated
6/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The HIHO 2 Study: Hospital Inpatient versus Home-based Rehabilitation after Total Hip Replacement
Scientific title
Effect of Hospital Inpatient versus HOme-based Rehabilitation on functional outcomes after Total Hip Arthroplasty.
The HIHO 2 Randomized Clinical Trial
Secondary ID [1] 292146 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HIHO 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Arthritis 303296 0
Condition category
Condition code
Musculoskeletal 302724 302724 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 302725 302725 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (Arm - 1) - Hospital Inpatient Rehabilitation followed by a Monitored HOme-based programme (HI)

Comparator (Arm - 2) - Standard treatment which is a Monitored HOme-based programme (HO)

Participants will have their elective total hip replacement surgery in an acute hospital.They will be reviewed by the treating team and if assessed as able to be discharged home they will be randomly allocated to one of the two arms of the study.

Those allocated to HI will be admitted to a rehabilitation hospital for 10 days. They will receive supervised physiotherapy comprising of 1-1.5 hours of one:one therapy plus 1-1.5 hours of class based exercises, a total of 2-3hours, Monday through Friday. They will receive 1-1.5 hours of one:one therapy on Saturday and Sunday. The inpatient rehabilitation programme combines general aerobic and functional exercises combined with muscle-specific exercises that focus on lower limb strengthening, joint range of motion, neuromuscular coordination and restoration of a normal gait pattern.

After discharge from the inpatient unit participants will attend the monitored group exercise sessions as per HO (below) for monitoring and progression of the programme.

All participants will be required to complete a diary detailing the programme adherence, health care utilisation, health expenditure and social costs related to carer burden.

An additional Functional Independence Measure (FIM) will be recorded for this arm on admission and discharge from the inpatient unit.
Intervention code [1] 298126 0
Treatment: Other
Intervention code [2] 298127 0
Rehabilitation
Comparator / control treatment
The Comparator - (Arm - 2) Monitored HOme-based programme (HO)

The HO will be based on the standard care in the local health district and on guidelines for exercises in the elderly and those with osteoarthritis. Prior to discharge from the acute hospital the particpants will be familiarised with a sheet of simple exercises to perform at home. Three weeks after surgery they will attend a group exercise session at their local physiotherapy department and receive instruction on the home-based exercise programme.
The programme comprises general aerobic components as well as general functional and muscle specific exercises focused on restoring hip mobility, lower limb strength, normal neuromuscular co-ordination and gait patterns. Participants are instructed to perform the exercises, unsupervised at home, at least four days per week, for around forty minutes. They are expected to attend two group classes from the third to tenth week.
Control group
Active

Outcomes
Primary outcome [1] 302179 0
Walking distance at 26 weeks after surgery, as measured by the Six-Minute Walk Test (6MWT). In comparison to the 6MWT pre-surgery.

The 6MWT is a measure of functional mobility and is influenced by multiple factors, such as pain, lower limb strength and joint mobility which are altered by total hip surgery. The intervention of rehabilitation aims to address these factors and improve the recipient's ability to walk. The 6MWT is highly reproducible within the individual and is likely to be less susceptible to misinterpretation, cultural sensitivity or be prone to the floor or ceiling effects that are associated with some patient reported outcomes. In addition, the use of this observer-rated outcome is less likely than a patient rated-outcome measure to be influenced by patient preference which is a feature of studies where the intervention cannot be blinded from recipient.
Timepoint [1] 302179 0
Pre-surgery and 26 weeks after surgery

Secondary outcome [1] 335090 0
Walking distance; 6MWT
Timepoint [1] 335090 0
3 weeks after surgery, 10 week after surgery and 52 weeks after surgery
Secondary outcome [2] 335092 0
Functional Mobility; International Classification of Functioning, Disability and Health (ICF) Based Mobility Assessment Tool (IBMAT) - Clinician Rated
Part of a nested study
Timepoint [2] 335092 0
Pre-surgery, 3 weeks after surgery and 26 weeks after surgery
Secondary outcome [3] 335093 0
Functional Mobility; IBMAT Patient-rated
Part of a nested study
Timepoint [3] 335093 0
3 weeks after surgery, 26 weeks after surgery
Secondary outcome [4] 335094 0
Hip pain and function (patient-rated); Hip Disability and Osteoarthritis Outcome Score (HOOS)
Timepoint [4] 335094 0
Pre-surgery, 3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery and 52 weeks after surgery
Secondary outcome [5] 335095 0
Hip pain and function (patient-rated); Oxford Hip Score (OHS)
Timepoint [5] 335095 0
Pre-surgery, 3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery and 52 weeks after surgery
Secondary outcome [6] 335096 0
Health related quality of life; Euroquol-5D (EQ-5D)
Timepoint [6] 335096 0
Pre-surgery, 3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery, 52 weeks after surgery
Secondary outcome [7] 335098 0
Time absent form work (participant)

Participant self report in diary provided
Timepoint [7] 335098 0
3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery, 52 weeks after surgery
Secondary outcome [8] 335099 0
Carer Time Absent from Work
Participant self report in diary provided
Timepoint [8] 335099 0
3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery, 52 weeks after surgery
Secondary outcome [9] 335101 0
Post Surgical Complications

Patient self report in diary supplied and data linkage to medical records
Timepoint [9] 335101 0
3 weeks after surgery, 10 weeks after surgery, 26 weeks after surgery, 52 weeks after surgery
Secondary outcome [10] 335102 0
Patient's perceived change in distance walked in the 6MWT
Part of a nested study

Investigator asks a direct question designed for the study
Timepoint [10] 335102 0
10 weeks after surgery and 26 weeks after surgery
Secondary outcome [11] 335103 0
Importance of perceived change in mobility
Part of a nested study
Investigator asks a direct question designed for the study
Timepoint [11] 335103 0
10 weeks after surgery and 26 weeks after surgery
Secondary outcome [12] 335104 0
Preference for rehabilitation model
Investigator direct question
Timepoint [12] 335104 0
Pre-surgery
Secondary outcome [13] 335105 0
Satisfaction with model of rehabilitation received
Visual Analogue Score designed for the study
Timepoint [13] 335105 0
10 weeks after surgery
Secondary outcome [14] 335106 0
Satisfaction with Hip Surgery
Investigators direct question
Timepoint [14] 335106 0
52 weeks after surgery
Secondary outcome [15] 335733 0
Direct Health Care Costs (visits to health professionals)

Patient self report in diary supplied and data linkage to patient medical records
Timepoint [15] 335733 0
3 weeks, 10 weeks, 26 weeks and 52 weeks after surgery

Eligibility
Key inclusion criteria
Adults presenting to Fairfield hospital for an initial, single side, planned, total hip replacement for treatment of hip arthritis secondary to, but not limited to, osteoarthritis, avascular necrosis or congenital hip deformity.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand the requirements of the study. This may include but is not limited to, a history of dementia, memory impairment secondary to stoke or brain injury or developmental cognitive impairment.
Inability to read English.
Inability to perform an exercise programme without hands on support or supervision from another person.
Inability to complete 52 weeks follow up (eg. moving interstate)
Pregnancy
The need for restricted weight-bearing through the operated limb.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telephone post-surgery.
Randomisation will take place 2-5 days following surgery once it has been confirmed that participants are likely to be cleared for discharge to home.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to one of the two arms using the method of minimisation stratified for variables that affect primary outcome. The variables are; age (less than or equal to 65 years and greater than 65 years), height (less than or equal to 163cm and greater than 163cm) and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Individuals who are eligible for the study but decline randomisation will be asked to join an observational arm. This group of participants will receive standard care; that is they will receive the monitored home-based therapy programme by choice. They will be assessed pre-surgery in the same way as the participants in the HI and HO groups. They will be assessed at 26 weeks for the primary and secondary outcomes as listed previously for the HI and HO groups.
The results of the two nested studies looking at the Minimal Important Change (MIC) of the 6MWT and the parameters of the IBMAT will be reported separately to the results of the main HIHO 2 Study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of covariance will be used for the primary outcome (change in distance walked in the 6MWT between baseline and 26 weeks), with treatment group as the main study factor and age, gender, height, and patient preference as covariates.

For the continuous secondary outcome variable measured at multiple time-points (6MWT, the EQ5D, the HOOS and the OHS), a repeat measures analysis will be used to compare rates of recovery in these variables across time.

Nonparametric tests and chi-squared tests will be used to compare satisfaction with both rehabilitation and surgical outcome, return to work data, and adverse-event related data between the two randomized groups as appropriate.

The sensitivity of IBMAT will be assessed by comparing the pre-operative scores with 3 and 26 week scores, comparing the median item scores at these time points, testing for significant changes using the Wilcoxon signed rank test for individual items. The total IBMAT score will be correlated with the change in 6MWT distance to assess concurrent validity. Significance will be computed using the t-test.
The reliability of the IBMAT(P) will be analysed by comparing scores from the clinician and the patient on the same visit by determining the percentage of absolute agreement, Kappa values and intra class correlation coefficients. Rasch analysis will be used to demonstrate relative item difficulty to allow comparison of the item difficulty with that found in other diagnostic groups.

The observation group change in score on the primary and secondary outcomes will be compared with those in the Home-based group, adjusting for the aforementioned, with the exception of preference.

For the nested study, investigating patient perceived important improvement thresholds for walking distance in the 6MWT and mobility at 10 and 26 weeks, anchor- and distribution-based methods will be used, including receiver operating curve methods producing sensitivity and specificity indices, and distribution-based change thresholds using two methods utilising effect size. Agreement will be assessed using Kappa.






Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/11/2017
Actual
17/11/2017
Date of last participant enrolment
Anticipated
1/11/2019
Actual
5/12/2017
Date of last data collection
Anticipated
1/11/2020
Actual
5/12/2017
Sample size
Target
64
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8068 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 16111 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 296458 0
Commercial sector/Industry
Name [1] 296458 0
Medibank Private
Country [1] 296458 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
HammondCare
Address
HammondCare, Level 2, 447 Kent St Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 295414 0
None
Name [1] 295414 0
Address [1] 295414 0
Country [1] 295414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297683 0
St Vincent's Hospital HREC
Ethics committee address [1] 297683 0
Ethics committee country [1] 297683 0
Australia
Date submitted for ethics approval [1] 297683 0
16/11/2016
Approval date [1] 297683 0
06/02/2017
Ethics approval number [1] 297683 0
HREC/16/SVH/331

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74810 0
A/Prof Justine M Naylor
Address 74810 0
Senior Principal Research Fellow, Orthopaedics, SWSLHD;
Conjoint A/Professor, UNSW;
Director, Whitlam Orthopaedic Research Centre
Locked Bag 7103
Liverpool
NSW 1871
Country 74810 0
Australia
Phone 74810 0
+61287389253
Fax 74810 0
+61296027187
Email 74810 0
Justine.Naylor@sswahs.nsw.gov.au
Contact person for public queries
Name 74811 0
Carol E Connolly
Address 74811 0
Braeside Hospital
Locked bag 82
Wetherill Park
NSW 1851
Country 74811 0
Australia
Phone 74811 0
+61297568838
Fax 74811 0
+61297568839
Email 74811 0
cconnolly@hammond.com.au
Contact person for scientific queries
Name 74812 0
Carol E Connolly
Address 74812 0
Braeside Hospital
Locked bag 82
Wetherill Park
NSW 1851
Country 74812 0
Australia
Phone 74812 0
+61297568838
Fax 74812 0
+61297568839
Email 74812 0
cconnolly@hammond.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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