Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000065190
Ethics application status
Approved
Date submitted
21/12/2018
Date registered
17/01/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Face-to-face physiotherapy compared to a supported home exercise program for the management of musculoskeletal conditions: the REFORM trial
Scientific title
Face-to-face physiotherapy compared to a supported home exercise program for the management of musculoskeletal conditions: the REFORM trial
Secondary ID [1] 296737 0
None
Universal Trial Number (UTN)
Trial acronym
The REFORM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal conditions 310603 0
Condition category
Condition code
Musculoskeletal 309317 309317 0 0
Other muscular and skeletal disorders
Musculoskeletal 309318 309318 0 0
Osteoarthritis
Injuries and Accidents 309319 309319 0 0
Fractures
Musculoskeletal 309320 309320 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single-blind randomised controlled pragmatic non-inferiority trial will be undertaken to compare a course of physiotherapy as typically provided in Sydney government hospitals with a supported home exercise program administered through an App and supplemented with text messages and two telephone calls. Cost-effectiveness will be evaluated from a health funder and patient perspective.

Participants allocated to the Supported Home Exercise Group will initially receive one face-to-face session with the trial physiotherapist (study coordinator), lasting 30 to 60 minutes. They will then be managed remotely for the next 6 weeks. During the initial session the trial physiotherapist (study coordinator) will prescribe an individualised 6-week home exercise program consisting of a battery of 5 to 10 exercises. This will be delivered to patients’ mobile devices using an App (www.physiotherapyexercises.com). The number of repetitions and sets will be determined by the trial physiotherapist (study coordinator). Participants will be asked to complete their exercises at least once every day for the intervention period of 6 weeks. Participants will record exercise adherence on their App. These data will be automatically transferred to a password protection section of the website which will be accessed by the trial physiotherapist (study coordinator) to remotely monitor exercise adherence. The trial physiotherapist (study coordinator) will provide ongoing support through weekly text messages. The purpose of these text messages will be to encourage adherence to the prescribed exercises and provide the participants with encouragement. The participants will also receive a telephone call from the trial physiotherapist (study coordinator) at 2 and 4 weeks to ensure adherence and provide feedback, support and advice. Participants will be rung more frequently if their exercise adherence is poor. There will be the option to provide an additional face-to-face physiotherapy session if a participant deteriorates or the trial physiotherapist (study coordinators) is concerned about the participant’s safety or well being for any reason.
Intervention code [1] 313045 0
Treatment: Other
Comparator / control treatment
Participants allocated to the Face-to-face Physiotherapy Group will receive a course of physiotherapy as typically provided in Sydney government hospitals. This could involve up to three sessions per week for up to 6 weeks or group classes. The number of sessions per week for each participant will be determined by the treating physiotherapist and may be gradually decreased and completed during the intervention period if a participant recovers and to avoid unnecessary treatment.
Control group
Active

Outcomes
Primary outcome [1] 308285 0
The Patient-Specific Functional Scale (PSFS)
Timepoint [1] 308285 0
6 weeks from randomisation
Secondary outcome [1] 354520 0
The Patient-Specific Functional Scale (PSFS)
Timepoint [1] 354520 0
26 weeks from randomisation
Secondary outcome [2] 354521 0
The Tampa Scale For Kinesiophobia
Timepoint [2] 354521 0
6 weeks and 26 weeks from randomisation
Secondary outcome [3] 354522 0
Pain measured using a 0-10 Numerical Rating Scale
Timepoint [3] 354522 0
6 and 26 weeks from randomisation
Secondary outcome [4] 354523 0
Patient Global Impression of Change
Timepoint [4] 354523 0
6 and 26 weeks from randomisation
Secondary outcome [5] 354524 0

Satisfaction with the health care service delivery using a 0-10 Numerical rating scale: 6 weeks from randomisation.
Timepoint [5] 354524 0
6 weeks from randomisation.
Secondary outcome [6] 354525 0
The EuroQol-5D
Timepoint [6] 354525 0
6 and 26 weeks from randomisation
Secondary outcome [7] 354526 0
Function Component of the Later Life Function and Disability Instrument
Timepoint [7] 354526 0
6 and 26 weeks from randomisation
Secondary outcome [8] 354550 0
Frequency component of the Later Life Function and Disability Instrument
Timepoint [8] 354550 0
6 and 26 weeks from randomisation
Secondary outcome [9] 354551 0
Limitations component of the Later Life Function and Disability Instrument
Timepoint [9] 354551 0
6 and 26 weeks from randomisation
Secondary outcome [10] 365733 0
Economic evaluation from a health funder and patient perspective. If supported home exercise is statistically non-inferior to face-to-face physiotherapy, then we will conduct a cost-minimisation analysis; otherwise we will conduct cost-effectiveness analysis. The cost of delivering the physiotherapy intervention in the two arms of the trial will be determined using standard micro-costing methods. All costs will be in 2019 Australian dollars. Healthcare utilisation will be determined by patient self-report. Patient costs will include the costs associated with the time to: attend the face-to-face sessions with the physiotherapist (including travel time), receive the telephone calls from the trial physiotherapist and complete the home exercise program. We will also capture the costs of lost productivity.
Timepoint [10] 365733 0
6 and 26 weeks from randomisation

Eligibility
Key inclusion criteria
A person will be eligible to participate if he or she:
• is 18 years or over and able to provide informed consent in writing
• has a musculoskeletal condition. Examples include: back pain, hip or knee osteoarthritis, whiplash-associated disorders, ankle sprains, post fracture, sporting injury and post hip or knee replacement
• is seeking physiotherapy treatment at the participating hospital
• can speak and can read English enough to give informed consent
• is able to participate for 6 weeks and will be available for 6 and 26 week follow up assessments
• has access to a smart phone with internet connection
• is identified by the hospital physiotherapist or trial physiotherapists (study coordinator) to have a condition appropriate for treatment with exercise, support and advice.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A person will be excluded if he or she::
• is pregnant
• has a mental illness which may affect compliance to treatment
• is at risk of falling while performing the home exercises
• is at clinical risk without face to face physiotherapy
• is on a post-operative exercise regime prescribed by a surgeon
• is deemed at risk of harm without face to face physiotherapy

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)
The hospital and trial physiotherapists responsible for determining a participant's eligibility to the trial will not have access to the randomisation schedule. Randomisation will occur following the consent, screening and baseline assessment of each participant. The trial physiotherapist will request randomisation from an independent and off-site person. The person responsible for central randomisation will notify the trial physiotherapist of participants’ allocation by email. Trial staff will then notify the participants. Participants' assignment will not be disclosed to the blinded assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The secure random allocation schedule will be computer-generated independently and kept off site. Randomisation will be blocked to ensure equal numbers in both groups and stratified by site. The allocation schedule will be concealed from potential participants and from all staff associated with the trial.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis with these performed and interpreted blinded to treatment group according to a pre-specified statistical analysis plan. Separate analyses will be conducted on each outcome. Between-group comparisons of each outcome will be conducted using regression models in which the outcome will be a linear function of a dummy-coded variable representing group membership (Supported Home Exercise Group or Face-to-face Physiotherapy Group) and a dummy-coded variable for stratum (site)., Baseline scores will be included in the model to increase statistical precision. If more than 5% of data are missing for a particular analysis, multiple imputation will be used to account for missing data provided the missing at random assumption appears plausible.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
19/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12594 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 12595 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 12596 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 12597 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 24968 0
2170 - Liverpool
Recruitment postcode(s) [2] 24969 0
2560 - Campbelltown
Recruitment postcode(s) [3] 24970 0
2148 - Blacktown
Recruitment postcode(s) [4] 24971 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 301316 0
Government body
Name [1] 301316 0
Sydney Health Partners, Medical Research Future Fund - Rapid Applied Research Translation Grants
Country [1] 301316 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District
Address
John Walsh Centre for Rehabilitation Research, Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 300986 0
None
Name [1] 300986 0
Address [1] 300986 0
Country [1] 300986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302059 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302059 0
Ethics committee country [1] 302059 0
Australia
Date submitted for ethics approval [1] 302059 0
24/02/2017
Approval date [1] 302059 0
17/03/2017
Ethics approval number [1] 302059 0
RESP/16/287

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

Contacts
Principal investigator
Name 88982 0
Prof Lisa Harvey
Address 88982 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute of Medical Research
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 88982 0
Australia
Phone 88982 0
+61 2 9926 4594
Fax 88982 0
Email 88982 0
[email protected]
Contact person for public queries
Name 88983 0
Lisa Harvey
Address 88983 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute of Medical Research
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 88983 0
Australia
Phone 88983 0
+61 2 9926 4594
Fax 88983 0
Email 88983 0
[email protected]
Contact person for scientific queries
Name 88984 0
Lisa Harvey
Address 88984 0
John Walsh Centre for Rehabilitation Research
The University of Sydney
Level 13, Kolling Institute of Medical Research
Royal North Shore Hospital, St Leonards, NSW, 2065
Country 88984 0
Australia
Phone 88984 0
+61 2 9926 4594
Fax 88984 0
Email 88984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data may be shared one year after publication, however at present the dates of data sharing are unknown.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial.2022https://dx.doi.org/10.1136/bmjopen-2021-057790
N.B. These documents automatically identified may not have been verified by the study sponsor.