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Trial registered on ANZCTR


Registration number
ACTRN12615000824561
Ethics application status
Approved
Date submitted
13/07/2015
Date registered
11/08/2015
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Date results provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation Following Total Hip Replacement (THR)
Scientific title
For THR patients who have been discharged from hospital, is telerehabilitation as effective as traditional face to face rehabilitation?
Secondary ID [1] 282271 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Replacement 288806 0
Condition category
Condition code
Surgery 289163 289163 0 0
Other surgery
Physical Medicine / Rehabilitation 295962 295962 0 0
Physiotherapy
Musculoskeletal 295963 295963 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This RCT will compare traditional face to face rehabilitation to a telerehabilitation program.

The study will comprise approximately 70 THR patients randomly assigned to a face-to-face group or telerehabilitation group.

The telerehabilitation protocol will involve a program similar in timing and content to the face-to-face rehabilitation program, except delivery will be directly into the homes of the participant via telerehabilitation technology on an iPad. The application used to deliver this rehabilitation is ‘Wellpepper Clinic’ by Wellpepper, Inc. Wellpepper is an application enabling healthcare professionals to create exercise programs that patients follow on a tablet device. The application provides notifications to complete the exercises, pre-recorded videos and instructions of their exercises and also enables the patient to record pain levels and difficulty at the conclusion of the exercise. Patients can contact their health care provider through a messaging system built in to the application. The healthcare professional has a ‘clinic’ version of Wellpepper installed on a tablet that enables them to review and adjust exercises and communicate with all patients under their care.
On discharge from hospital, participants randomised to the telerehabilitation group will either be provided an iPad with Wellpepper installed or if owning an iPad, have Wellpepper installed by a member of the research team prior to their discharge. They will undergo a single one to one twenty minute training session in the use of the Wellpepper application and eHAB system on iPads.
Telerehabilitation participants will have videos and instructions installed on to their Wellpepper application targeting strengthening exercises for quadriceps, hip abductors, extensors and flexors. They will receive three notifications per day via the Wellpepper application reminding them to perform their home exercise program (HEP). Participants will be expected to perform their HEP each time they receive a notification. Each HEP session will take approximately 20 minutes to complete. At the conclusion of each exercise they will be prompted by the application to record how much pain they experienced during the exercise and how difficult they found the exercise. Once recorded, this information becomes immediately available to the physiotherapist. A physiotherapist will review the Wellpepper clinic application weekly to review participant’s progress, adjust exercises as required and respond to any communication via the messaging system. Patients who have not accessed the application and recorded exercises in Wellpepper over 3 consecutive days will be contacted via telephone to discuss their progress. At two weeks following hospital discharge, participants will receive a thirty minute physiotherapy session via real time video-conferencing using the eHAB system. This session will enable analysis and advice regarding gait retraining and exercise progression. Following this session participants will continue to use the Wellpepper application to facilitate them performing their HEP for approximately twenty minutes, three times per day until six weeks post-operatively.
Intervention code [1] 286901 0
Rehabilitation
Comparator / control treatment
On discharge from hospital, participants randomised to the face-to-face group will receive usual care defined as: a paper HEP targeting strengthening exercises for quadriceps, hip abductors, extensors and flexors; they will be advised to perform their HEP three times per day and provided with an exercise diary to record exercise compliance; at two, four and six weeks post-operatively they will attend QEII Jubilee Hospital Physiotherapy Outpatients Department for a 30 minute face-to-face physiotherapy session with a focus on reviewing and progressing their HEP and gait re-training.
Control group
Active

Outcomes
Primary outcome [1] 289279 0
Hip disability and osteoarthritis outcome score
Timepoint [1] 289279 0
6 months post surgery
Primary outcome [2] 289280 0
Functional health and well being from the patients perspective as assessed by the SF-12 score
Timepoint [2] 289280 0
6 months post surgery
Primary outcome [3] 289282 0
Mobility as assessed by the Timed up and go (TUG) test
Timepoint [3] 289282 0
6 months post surgery
Secondary outcome [1] 302146 0
Self reported health outcome as assessed by the EQ-5D questionnaire. Participants answer questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Timepoint [1] 302146 0
6 months post surgery
Secondary outcome [2] 302148 0
Hip flexion muscle strength using a hand held dynamometer
Timepoint [2] 302148 0
6 months post surgery
Secondary outcome [3] 302149 0
Participant satisfaction questionnaire pertaining to the rehabilitation program they received. This questionnaire is based off the validated health care satisfaction questionnaire developed by Gagnon et al 2006.
Timepoint [3] 302149 0
6 months post surgery
Secondary outcome [4] 315640 0
Balance as assessed by the Step Test
Timepoint [4] 315640 0
6 months post surgery
Secondary outcome [5] 315641 0
System Usability Scale (for telerehabilitation group)
Timepoint [5] 315641 0
6 weeks post surgery
Secondary outcome [6] 316074 0
Hip extension muscle strength using a hand held dynamometer
Timepoint [6] 316074 0
6 months post surgery
Secondary outcome [7] 316075 0
Hip abduction muscle strength using a hand held dynamometer
Timepoint [7] 316075 0
6 months post surgery
Secondary outcome [8] 316076 0
Hip adduction muscle strength using a hand held dynamometer
Timepoint [8] 316076 0
6 months post surgery
Secondary outcome [9] 316077 0
Hip internal rotation muscle strength using a hand held dynamometer
Timepoint [9] 316077 0
6 months post surgery
Secondary outcome [10] 316079 0
Hip external rotation muscle strength using a hand held dynamometer
Timepoint [10] 316079 0
6 months post surgery
Secondary outcome [11] 316081 0
Knee extension muscle strength using a hand held dynamometer
Timepoint [11] 316081 0
6 months post surgery

Eligibility
Key inclusion criteria
Inclusion criteria: participants will be eligible for inclusion if they are undergoing primary elective THR, have normal mentation, can attend five outpatient physiotherapy rehabilitation sessions (one pre-operatively, then one each at weeks 2, 4, 6, and 6 months post-operatively), and are able to provide signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: participants will be excluded if they have co-morbidities or medical conditions preventing participation in rehabilitation. These may be pre-existing or as the result of peri-operative complications. Patients who are undergoing revision THR or are unable to mobilise full weight bearing in a bipedal manner with or without a walking aid will also be excluded.

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)
Randomisation will be restricted by a permuted block design. Randomisation codes will be sealed in sequentially numbered opaque envelopes, which will be assigned to participants in their order of recruitment by an independent administrative officer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer random numbers generator to allocate participants to either the face-to-face (control) group or the telerehabilitation (intervention) group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were conducted based on the primary outcome, the Hip disability and Osteoarthritis Outcome Score (HOOS). Using existing pre-post THR HOOS data, calculations using both a non-inferiority method and a test-of-difference method were undertaken to ensure sufficient powering of the study.
Method one used a non-inferiority power calculation as described by Jones 1996.

Delta was taken from the minimally clinical important improvements (MCII) for pain, symptoms and Quality of Life (QOL) components of the HOOS as established by Paulsen 2014. Standard deviation values were taken from Duivenvoorden 2013 who investigated anxiety and depressive symptoms before and after THR using the HOOS as an outcome measure. The value used was the standard deviation of the change in HOOS pain, symptoms and QOL scores from pre-operatively to 12 months post-operative. Calculations were based on 80% power. Duivenvoorden documented change in scores for all five sub-scales of the HOOS however Paulsen only reported on three of the five sub-scales of the HOOS, pain, symptoms and QOL. Sample sizes were therefore determined using each of the three HOOS sub-scales, pain, symptoms and QOL. QOL values yielded the largest sample size of 30 per group.
Method two calculated sample size using the hypothesis testing method described by Lindsey 2001.


This method ensures adequate sample size so that any meaningful difference between groups will be detected. Values for were taken from Duivenvoorden. The meaningful difference values used were MCIIs established by Paulsen. Effect size was assumed to be 0.5. QOL values yielded the largest sample size of 30 per group.
Both methods yielded a sample size of 30 per group. Accounting for a 15% drop out rate, a sample size of 35 per group is required, equating to a total of 70 participants.


Both intention-to-treat and per-protocol analyses as recommended in the extension of the CONSORT guideline for non-inferiority trials will be performed. The treatment effect of each intervention will first be computed by comparing the pre-to-post intervention measures. Non-inferiority will be implied if the treatment effect of the telerehabilitation intervention is within the minimally clinical important improvement values of the control group. Treatment effects will be calculated on the pre-to-post intervention outcome. A secondary analysis will be performed on the post treatment to 6 month outcome. The clinical treatment effect of each intervention group will be further analysed using a one-tailed independent sample t-test on pre-to-post intervention changes across the range of outcome measures. An alpha level of 0.05 will be used for this analysis. In addition to intention-to-treat and per-protocol analyses, a sensitivity analysis using multiple imputation (best subsets regression) will be used to replace missing data to determine its effect on the observed results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2015
Actual
15/09/2015
Date of last participant enrolment
Anticipated
Actual
27/04/2017
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287047 0
Hospital
Name [1] 287047 0
QEII Jubilee Hospital
Country [1] 287047 0
Australia
Primary sponsor type
Hospital
Name
QEII Jubilee Hospital
Address
Corner of Kessels & Troughton Rd, Coopers Plains, QLD, 4109, Australia
Country
Australia
Secondary sponsor category [1] 285821 0
University
Name [1] 285821 0
The University of Queensland
Address [1] 285821 0
The University of Queensland, St Lucia, QLD, 4072, Australia
Country [1] 285821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289078 0
Metro South Health Research Ethics Committee
Ethics committee address [1] 289078 0
Ethics committee country [1] 289078 0
Australia
Date submitted for ethics approval [1] 289078 0
Approval date [1] 289078 0
05/01/2015
Ethics approval number [1] 289078 0
HREC/14/QPAH/628

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

Contacts
Principal investigator
Name 39098 0
Mr Mark Nelson
Address 39098 0
Physiotherapy Dept - QEII Jubilee Hospital
Locked Bag 2
Archerfield, QLD
4108
Country 39098 0
Australia
Phone 39098 0
+61731826173
Fax 39098 0
Email 39098 0
mark.nelson@health.qld.gov.au
Contact person for public queries
Name 39099 0
Mark Nelson
Address 39099 0
Physiotherapy Dept - QEII Jubilee Hospital
Locked Bag 2
Archerfield, QLD
4108
Country 39099 0
Australia
Phone 39099 0
+61731826173
Fax 39099 0
Email 39099 0
mark.nelson@health.qld.gov.au
Contact person for scientific queries
Name 39100 0
Mark Nelson
Address 39100 0
Physiotherapy Dept - QEII Jubilee Hospital
Locked Bag 2
Archerfield, QLD
4108
Country 39100 0
Australia
Phone 39100 0
+61731826173
Fax 39100 0
Email 39100 0
mark.nelson@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6026Study protocolNelson, M., Bourke, M., Crossley, K., & Russell, T. (2017). Telerehabilitation versus traditional care following total hip replacement: a randomized controlled trial protocol. JMIR Research Protocols, 6(3).  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.