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Trial registered on ANZCTR


Registration number
ACTRN12615000724572
Ethics application status
Approved
Date submitted
4/06/2015
Date registered
15/07/2015
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Date results information initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Physiotherapy Integrated Motivational Interviewing and Smartphone Technology to Increase Physical Activity in Patients with Low Back Pain: A Cluster Randomised Controlled Trial
Scientific title
The effect of Physiotherapy Integrated Motivational Interviewing and Smartphone Technology to Increase Physical Activity in Patients with Low Back Pain: A Cluster Randomised Controlled Trial
Secondary ID [1] 286859 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 295254 0
Condition category
Condition code
Musculoskeletal 295499 295499 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295687 295687 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 6, 30 minute weekly sessions of usual physiotherapy care, the physiotherapy content of which will be at the discretion of the treating therapist. This will be in addition to their initial physiotherapy session, during which they will be recruited for the trial. Throughout each session the physiotherapist will communicate with patients in a style consistent with Motivational Interviewing (MI). Physiotherapists will be trained on how to communicate in an MI consistent style via two 4 hour training sessions prior to the commencement of the study. Training will be provided by two of the study coordinators who are both trained in the use of MI. One of the study coordinators is a PhD candidate and current practicing physiotherapist and the other an academic and current practicing psychologist. As part of training physiotherapists will participate in an audio recorded role play with one of the study coordinators. Therapists will be provided with a copy of this recording to reflect and improve on their MI techniques. Physiotherapists will practice learned MI techniques until patient recruitment commences. Prior to patient recruitment physiotherapists will receive a 3 hour training session to review learned MI techniques. To establish a measure of MI proficiency, physiotherapists will participate in a 20-30 minute role play with one of the study coordinators following this review session. This will be audio recorded and reviewed by a third party assessor not otherwise associated with the study. The assessor will use the Motivational Interviewing Treatment Integrity scale to assess the interaction and provide a measure of therapist proficiency in MI. This will be repeated 6 weeks into patient recruitment to establish any change in MI proficiency. Between sessions, patients will access a newly developed MI app. The app will endeavor to replicate face to face MI and help participants to formulate their own reasons for increasing their activity levels though a question and answer format. The majority of questions will be open ended and focus on building the importance of increasing activity levels and the confidence the participant has in being able to achieve this. Finally an activity related goal will be developed in conjunction with the physiotherapist and the smartphone application. Participants will access the app two to three times per week. The amount of time required for each log in will vary between participants and depend on how skilled they are at using smartphones, however each session has been designed to last no longer than 15 minutes. Participants will then access the smartphone application for a further 6 weeks after physiotherapy has ceased. There will be a central web server accessible to physiotherapists from intervention clusters and the study coordinators. This will allow app usage to be monitored and the answers participants provide may be reviewed. A review of the answers may take place if the therapist wishes to use this information to plan upcoming sessions. The app will contain a feature, whereby if the participant gets stuck on a certain module, an email will be generated to one of the study coordinators, a current practicing psychologist who has extensive training in MI. The participant and the study coordinator will converse via email to problem solve why the participant is not progressing though the application. This will be done in an MI consistent manner. Once the study coordinator establishes that the participant is ready to recommence the app they will be instructed to do so.
Intervention code [1] 292027 0
Rehabilitation
Intervention code [2] 292028 0
Behaviour
Intervention code [3] 292183 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive 6 sessions of usual physiotherapy care. The content of each physiotherapy session will be at the discretion of the treating therapist.
Control group
Active

Outcomes
Primary outcome [1] 295234 0
Average number of minutes of moderately vigorous activity per day measured by accelerometer recordings and activity diaries in the week of assessment.
Timepoint [1] 295234 0
Baseline and 7 weeks. Participants will receive a reminder call from a research assistant half way through their assessment weeks. The purpose of this call will be to remind participants to wear their accelerometer and complete their activity diary and to ensure there are no issues with either of these procedures.

In addition to this, participants will be provided with the email address of their research assistant. In the event there are issues with the accelerometer, participants will be able to contact their research assistant for assistance.
Secondary outcome [1] 315156 0
Participant Function (Patient Specific Functional Scale average score and primary activity score)
Timepoint [1] 315156 0
Baseline and 7 weeks
Secondary outcome [2] 315157 0
Back pain related disability (Oswestery Disability Index)
Timepoint [2] 315157 0
Baseline and 7 weeks
Secondary outcome [3] 315158 0
Pain-related self efficacy (Pain Self Efficacy Questionnaire)
Timepoint [3] 315158 0
Baseline and 7 weeks
Secondary outcome [4] 315159 0
Motivational Interviewing therapist proficiency (Client Evaluation of Motivational Interviewing Questionnaire)
Timepoint [4] 315159 0
7 weeks, patients in the intervention group only.
Secondary outcome [5] 315160 0
Motivational Interviewing therapist proficiency (Motivational Interviewing Treatment Integrity Scale), physiotherapists in the intervention group only.
Timepoint [5] 315160 0
Baseline and 6 weeks into patient recruitment

Eligibility
Key inclusion criteria
3-12 week history of a new episode of low back pain (present for at least 24 hours and symptom free or at a baseline considered normal for the patient in the preceding 30 days), with or without radicular pain or radiculopathy.
English speaking.
Able to use simple smartphone applications.
Access to a Google Play or iTunes account or willing to create one.
Reside within 40km of their attending healthcare site.
Access to a compatible smartphone (iPhone 4 or greater or Android based phone), or tablet PC.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk of severe or extremely severe depression or anxiety (Patients will be screened prior to entry using the 21 item Depression Anxiety and Stress Scale)
Pregnant
Wait listed for lumbar surgery
Signs and symptoms consistent with cauda equina syndrome
Presence of medical red flags
Current spinal fracture

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)
Physiotherapists: Physiotherapists at intervention sites will be recruited as follows; Physiotherapists will be selected to be participated by the musculoskeletal unit stream leader based on work loads and other unit specific factors. Interested physiotherapists will contact one of the study coordinators to confirm their participation, who will advise the stream leader of this decision.

Patients: Patients will be selected by their treating physiotherapist based on the selection criteria. Physiotherapists will explain the study to patients and make it clear to patients that participation is voluntary. Physiotherapists will administer the DASS 21 to ensure they meet the inclusion criteria regarding depression and anxiety. Patients will be provided with an information and consent form to review and will be followed up by a research assistant who will confirm participation and obtain written consent at the initial home visit when baseline outcome measures will be taken.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster randomised controlled trial with health care site as the unit of randomisation. An independent researcher will place the name of each healthcare site will be placed into an opaque envelope using a random number generator. Sites will then alternately be allocated to intervention or control sites using a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Assessments will be carried out by a blinded research assistant who will conduct home visits to patients at baseline and 7 weeks. At the start of the assessment week the research assistant will drop off the accelerometer and patients will complete the standardised pen and paper outcome measures. Half way through the assessment week the research assistant will call the patient to remind them to wear their accelerometer. At the end of the assessment week the research assistant will pick up the accelerometer and download the data using propriety software.

Participants will also be provided with the email address of one of the study coordinators, so they can contact them if the accelerometer stops working.

To acknowledge the work and time physiotherapists will be donating to the project, physiotherapists will be provided with recruitment incentives for every 5 patients recruited (up to a maximum of 10 patients), and for the therapist who recruits the most patients overall across sites.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary and secondary outcomes will be entered into an ANCOVA using baseline scores as a co-variate to establish between groups at 7 weeks.

To establish consistency in the Motivational Interviewing skills of therapists, paired-sampled t-tests will be used comparing baseline scores with obtained at the conclusion of the study.

To achieve 80% power at a 0.05 significance level with a large effect size a total of 34 patients are required (Faul, Franz
Erdfelder & Edgar, 2007). As this is a cluster randomised trial the sample size needs to be increased due to outcome variation between clusters (van Breukelen & Candel, 2012). Assuming an intracluster correlation coefficient of 0.05, a total of 14 patients per cluster is required (Machin, Campbell, Tan & Tan, 2009). Therefore the target sample size will be set at 60 patients (15 for each cluster), to allow some loss to follow up.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3882 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 3883 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 3884 0
The Alfred - Prahran
Recruitment hospital [4] 3885 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 9775 0
3168 - Clayton
Recruitment postcode(s) [2] 9776 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 9777 0
3004 - Melbourne
Recruitment postcode(s) [4] 9778 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 291417 0
University
Name [1] 291417 0
La Trobe University
Address [1] 291417 0
La Trobe University
Kingsbury Drive
Bundoora
VIC
3086
Country [1] 291417 0
Australia
Primary sponsor type
University
Name
Alumni & Advancement Office, La Trobe University
Address
La Trobe University
Kingsbury Drive
Bundoora
VIC
3086
Country
Australia
Secondary sponsor category [1] 290093 0
Commercial sector/Industry
Name [1] 290093 0
Telstra Australia
Address [1] 290093 0
242 Exhibition Street
MELBOURNE
VIC, AUSTRALIA, 3000
Country [1] 290093 0
Australia
Secondary sponsor category [2] 294506 0
University
Name [2] 294506 0
La Trobe University School of Public Health
Address [2] 294506 0
Kingsbury Drive
Bundoora
3086
Country [2] 294506 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292966 0
Eastern Health Human Ethics Committee
Ethics committee address [1] 292966 0
Office of Research and Ethics
5 Arnold Street
Box Hill
Vic 3128
Ethics committee country [1] 292966 0
Australia
Date submitted for ethics approval [1] 292966 0
Approval date [1] 292966 0
16/02/2015
Ethics approval number [1] 292966 0
E12-2014
Ethics committee name [2] 292967 0
Monash Health
Ethics committee address [2] 292967 0
Research Support Services
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Ethics committee country [2] 292967 0
Australia
Date submitted for ethics approval [2] 292967 0
Approval date [2] 292967 0
02/06/2015
Ethics approval number [2] 292967 0
15067X
Ethics committee name [3] 292968 0
Alfred Health
Ethics committee address [3] 292968 0
Office of Ethics & Research Governance
5 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [3] 292968 0
Australia
Date submitted for ethics approval [3] 292968 0
Approval date [3] 292968 0
26/05/2015
Ethics approval number [3] 292968 0
47/15
Ethics committee name [4] 294263 0
La Trobe University Human Ethics Committee
Ethics committee address [4] 294263 0
La Trobe University
Ethics and Integrity/Research Office
Kingsbury Drive
Bundoora
Victoria
Australia
3086
Ethics committee country [4] 294263 0
Date submitted for ethics approval [4] 294263 0
Approval date [4] 294263 0
01/04/2015
Ethics approval number [4] 294263 0
E12-2014

Summary
Brief summary
This trial will aim to determine if smartphone based Motivational Interviewing supplemented with Motivational Interviewing provided during usual physiotherapy care can increase activity in patients with sub-acute low back pain.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 57826 0
Mr Jason Holden
Address 57826 0
C/o
Dr Paul O'Halloran
School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
Country 57826 0
Australia
Phone 57826 0
+61 3 9479 5607
Fax 57826 0
Email 57826 0
jpholden@students.latrobe.edu.au
Contact person for public queries
Name 57827 0
Dr Paul O'Halloran
Address 57827 0
School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
Country 57827 0
Australia
Phone 57827 0
+61 3 9479 5607
Fax 57827 0
Email 57827 0
p.ohalloran@latrobe.edu.au
Contact person for scientific queries
Name 57828 0
Dr Paul O'Halloran
Address 57828 0
School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
Country 57828 0
Australia
Phone 57828 0
+61 3 9479 5607
Fax 57828 0
Email 57828 0
p.ohalloran@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is de-identified for analysis to maintain patient confidentiality.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary