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Trial registered on ANZCTR


Registration number
ACTRN12616000066482
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
21/01/2016
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of using an exercise App to improve adherence to home exercise programs prescribed by physiotherapists: a randomised controlled trial.
Scientific title
The effectiveness of using an exercise App to improve adherence to home exercise programs prescribed by physiotherapists: a randomised controlled trial.
Secondary ID [1] 288355 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper and lower limb orthopaedic/musculoskeletal conditions 297345 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297542 297542 0 0
Physiotherapy
Musculoskeletal 297571 297571 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive their home exercise programs via the App associated with www.physiotherapyexercises.com. The specific exercises will be prescribed by their treating physiotherapists prior to randomisation. Patients will be advised to complete their exercises as prescribed for 4 weeks. Patients will be instructed to record their adherence through the App. This information will be relayed back to a trial physiotherapist. The participants will be rung soon after receiving the App to ensure they are able to access it. They will also be rung at 2 weeks. In addition, participants will be rung at 1 and 3 weeks if they have not accessed the App in the preceding 7 consecutive days. The trial physiotherapist will also send patients text or email messages of encouragement and feedback about their progress on a weekly basis unless the participant requests not to receive these.
Intervention code [1] 293661 0
Rehabilitation
Intervention code [2] 293662 0
Treatment: Other
Intervention code [3] 293686 0
Behaviour
Comparator / control treatment
The control group will receive their home exercise programs as per current practice (i.e., exercise instructions on a sheet of paper). The specific exercises will be prescribed by their treating physiotherapists prior to randomisation and patients will be advised to complete their exercises as prescribed for 4 weeks. Participants in the control group will not receive any encouragement or feedback about their progress.
Control group
Active

Outcomes
Primary outcome [1] 297097 0
Self-Reported Exercise Adherence.

Participants will be asked to rate their adherence on a visual analogue scale anchored at one end with “0= Never performed my exercises” and at the other end with “10= Always performed my exercises”.
Timepoint [1] 297097 0
4 weeks after randomisaton
Secondary outcome [1] 320014 0
Patient-Specific Functional Scale (PSFS).

Patients will be asked to identify up to 3 activities which they find difficult to perform as a result of their condition. Patients will then be asked to rate each of their identified activities on a visual analogue scale anchored at one end with “0= Unable to perform activity” and at the other end “10= Able to perform activity at the same level as before the injury or problem.”
Timepoint [1] 320014 0
Baseline, and 4 weeks after randomisation.
Secondary outcome [2] 320015 0
The World Health Organisation Disability Assessment Schedule 2.0(WHODAS).
Timepoint [2] 320015 0
At baseline, and 4 weeks after randomisation.
Secondary outcome [3] 320016 0
Patient Global Impression of Change.

Participants will be asked to rate the change in their condition on a visual analogue scale anchored at one end with “0= A great deal worse” and the other end “10= A great deal better.”
Timepoint [3] 320016 0
4 weeks after randomisation.
Secondary outcome [4] 320017 0
Patient satisfaction with healthcare service delivery.

Participants will be instructed to rate their satisfaction on a visual analogue scale anchored at one end with "0= Not at all satisfied” and "10= Extremely satisfied”.
Timepoint [4] 320017 0
4 weeks after randomisation.
Secondary outcome [5] 320018 0
Assessor-reported exercise adherence.

Blinded assessors will ask a series of questions deemed appropriate in order to formulate an opinion on the participants' adherence over the preceding 4 weeks. They will then score this on a visual analogue scale anchored at one end with "0= Never performed his/her exercises" and at the other end with "10= Always performed his/her exercises."
Timepoint [5] 320018 0
4 weeks after randomisation

Eligibility
Key inclusion criteria
1. Patients who have sustained an upper or lower limb fracture, injury or other musculoskeletal condition
2. Patients who have been prescribed a set of home exercises for the next 4 weeks by their treating physiotherapist
3. Have been advised to complete their exercises at least 3 times per week
4. Have access to a smart phone, tablet device or computer with an active email account
5. Are over 18 years of age and are able to provide informed consent
6. Are willing to participate in the trial
7. Are not expected to require surgery or be readmitted to hospital during the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those who are unlikely or unwilling to co-operate (e.g. serious medical condition, cognitive impairment, drug dependency, psychiatric illness, behavioural problems)
2. If they are scheduled to receive face- to- face physiotherapy for their condition or injury within the next 4 weeks
3. Those who have limited English

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)
Participants will be screened by their treating physiotherapist for eligibility, and included in the trial if all criteria are met. The treating physiotherapist will not be aware at the time of inclusion which group the subject will be allocated to. Participants’ allocations will be placed in opaque, sequentially numbered and sealed envelopes and held offsite by an independent person. Once a participant passes the screening process and completes the initial assessment, the trial co-ordinator will contact this independent person who will open an envelope and reveal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure random-allocation schedule will be computer-generated prior to commencement of the trial by an independent person. The randomisation schedule will be blocked (1:1) ensuring equal numbers of participants are randomised to the intervention and control condition.
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
A sample size of 80 gives a better than 80% probability of detecting a between-group difference in exercise adherence of 2/10 points. This calculation is based on best available evidence which suggests that the SD in the control group is likely to be approximately 3 points. This assumes an alpha of 0.05 and a worse-case scenario of lost to follow-up of 10%.

All analyses will be conducted on an intention-to-treat basis. Separate analyses will be conducted on each outcome. Between-group comparisons will be conducted using linear regression with baseline scores included in the model to increase statistical precision and power. If necessary, outcomes will be transformed to approximate a normal distribution. Alternatively, it may be necessary to use a median regression model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2016
Actual
25/02/2016
Date of last participant enrolment
Anticipated
31/01/2017
Actual
15/01/2017
Date of last data collection
Anticipated
Actual
17/02/2017
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5089 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 12550 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 292712 0
Hospital
Name [1] 292712 0
Royal North Shore Hospital
Country [1] 292712 0
Australia
Funding source category [2] 292713 0
University
Name [2] 292713 0
John Walsh Centre for Rehabiliation Research, Sydney Medical School, University of Sydney
Country [2] 292713 0
Australia
Funding source category [3] 292718 0
Hospital
Name [3] 292718 0
Physiotherapy Department, Royal North Shore Hospital
Country [3] 292718 0
Australia
Primary sponsor type
University
Name
John Walsh Centre for Rehabilitation Research, Sydney Medical School, University of Sydney
Address
Level 13, Kolling Institute
Rserve Rd
Royal North Shore Hospital
St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 291445 0
Hospital
Name [1] 291445 0
Physiotherapy Department, Royal North Shore Hospital
Address [1] 291445 0
Royal North Shore Hospital
Reserve Rd
St Leonards
NSW
2065
Country [1] 291445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294198 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 294198 0
Level 13
Kolling Building
Royal North Shore Hospital
Reserve Rd
St Leonards, NSW 2065
Ethics committee country [1] 294198 0
Australia
Date submitted for ethics approval [1] 294198 0
09/11/2015
Approval date [1] 294198 0
02/12/2015
Ethics approval number [1] 294198 0
HREC/15/HAWKE/431

Summary
Brief summary
The primary purpose of our study is to determine whether home exercise programs delivered via an App have greater adherence rates than usual methods of prescription used by physiotherapists.

We will conduct an assessor- blinded, randomised controlled trial, with a sample size of 80.

Subjects will be deemed eligible for inclusion if they meet the following criteria:
* have sustained an upper or lower limb fracture, injury or other musculoskeletal condition
* have been prescribed a set of exercises for the next 4 weeks (or longer) by their treating physiotherapist
* have been advised to complete their exercises at least 3 times per week
* have access to a smart phone, tablet device or computer
* are over 18 years of age and are able to provide informed consent
* are willing to participate in the trial
* are not expected to require surgery or be readmitted to hospital during the trial

Subjects will be excluded if they:
* are unlikely or unwilling to co-operate (e.g. serious medical condition, cognitive impairment, drug dependency, psychiatric illness, behavioural problems)
* are scheduled to receive face- to- face physiotherapy for their condition or injury within the next 4 weeks
* have limited English


This trial will be undertaken in patients who have been prescribed a home exercise program by physiotherapists based on the orthopaedic ward or short stay surgical unit of Royal North Shore Hospital (RNSH); or from the outpatient department or hand therapy clinic of Royal North Shore Hospital (RNSH). Participants will be randomised to receive their home exercise program delivered via either the current paper-based method alone, or via our App with supplementary follow-up phone calls. The primary outcome will be self-rated exercise adherence in the first 4 weeks following prescription of exercises by a physiotherapist. The secondary outcomes will include functional status, degree of disability, perceptions of treatment effectiveness, satisfaction with healthcare service delivery and assessor-rated exercise adherence.

Baseline assessments will be conducted just prior to randomisation by treating physiotherapists. Follow up assessments will be conducted 4 weeks after randomisation by a blinded assessor via telephone interview and online survey.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62862 0
Prof Lisa Harvey
Address 62862 0
John Walsh Centre for Rehabilitation Research
Lvl 13 Kolling Building
Royal North Shore Hospital
Reserve Rd
St Leonards
NSW 2065
Country 62862 0
Australia
Phone 62862 0
+61 (02) 99264594
Fax 62862 0
Email 62862 0
lisa.harvey@sydney.edu.au
Contact person for public queries
Name 62863 0
Lisa Harvey
Address 62863 0
John Walsh Centre for Rehabilitation Research
Lvl 13 Kolling Building
Royal North Shore Hospital
Reserve Rd
St Leonards
NSW 2065
Country 62863 0
Australia
Phone 62863 0
+61 (02) 99264594
Fax 62863 0
Email 62863 0
lisa.harvey@sydney.edu.au
Contact person for scientific queries
Name 62864 0
Lisa Harvey
Address 62864 0
John Walsh Centre for Rehabilitation Research
Lvl 13 Kolling Building
Royal North Shore Hospital
Reserve Rd
St Leonards
NSW 2065
Country 62864 0
Australia
Phone 62864 0
+61 (02) 99264594
Fax 62864 0
Email 62864 0
lisa.harvey@sydney.edu.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

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

Documents added automatically
No additional documents have been identified.