Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000659707
Ethics application status
Approved
Date submitted
4/06/2013
Date registered
17/06/2013
Date last updated
14/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Upskilling physiotherapists in evidence-based assessment and management of patients with rheumatoid arthritis: a single-blind randomised controlled trial
Scientific title
A randomised controlled trial on the effectiveness of the Rheumatoid Arthritis for Physiotherapists eLearning package (RAP-eL) in improving the confidence, knowledge and skills of Australian registered physiotherapists in rheumatoid arthritis management
Secondary ID [1] 282622 0
Nil
Universal Trial Number (UTN)
U1111-1144-0005
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiotherapists’ confidence and clinical knowledge in managing people with rheumatoid arthritis 289315 0
Condition category
Condition code
Inflammatory and Immune System 289652 289652 0 0
Rheumatoid arthritis
Public Health 289699 289699 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Rheumatoid Arthritis for Physiotherapist eLearning package is a series of four web-based learning modules (disease and recognition; early stages; chronic stages and extra-articular features and co-morbid conditions) and two case studies.

Each module consists of text content, videos of people with rheumatoid arthritis; practice points and clinical resources. The two case studies provide case histories and clinically related questions with answers.

It is expected that each module and case study should take no more than 30 minutes to complete. So in total the whole package could be completed in three hours.

During this study, physiotherapists will be give a period of four weeks in which to complete the modules and case studies. All learning modules will be made available at the one time so that the physiotherapist can work through it at his/her own pace.

The total time of intervention and follow up for the intervention group is 12 weeks while for the control group it is 17 weeks. This is because after the randomised controlled trial the study will continue as a cohort study to the eight week follow up period for each group. Because the control group will get access to the intervention at the end of week 5, the four weeks intervention for them plus the 8 week follow up period finishes at 17 weeks.
Intervention code [1] 287289 0
Behaviour
Intervention code [2] 287290 0
Other interventions
Comparator / control treatment
Access to Rheumatoid Arthritis for Physiotherapists eLearning package withheld during study period (wait-list control).
Control group
Active

Outcomes
Primary outcome [1] 289732 0
Change in the physiotherapist’s confidence in knowledge of, and clinical skills in, RA management. Measured by nine 'confidence in knowledge' and eight 'confidence in skills' questions each answered using a five-point Likert scale.
Timepoint [1] 289732 0
Timepoint 1: Prior to access to learning modules
Timepoint 2: Immediately after completion of learning modules
Timepoint 3: Eight weeks after completion of learning modules
Secondary outcome [1] 303122 0
Satisfaction in ability to manage people with RA. Measured using a 10 point scale with the left hand anchor (score 1) being "not at all satisfied" and the right hand anchor (score 10) being "extremely satisfied"
Timepoint [1] 303122 0
Timepoint 1: Prior to access to learning modules
Timepoint 2: Immediately after completion of learning modules
Timepoint 3: Eight weeks after completion of learning modules
Secondary outcome [2] 303123 0
Specific RA clinical knowledge. Measured using six clinically related questions each answered using a five point Likert scale.
Timepoint [2] 303123 0
Timepoint 1: Prior to access to learning modules
Timepoint 2: Immediately after completion of learning modules
Timepoint 3: Eight weeks after completion of learning modules
Secondary outcome [3] 303124 0
Knowledge of clinical management strategies. Measured using two modified ACREU clinical vignettes each followed by two clinically related questions regarding management plans, interventions, resources and referral pathways. These questions are answered using free text.
Timepoint [3] 303124 0
Timepoint 1: Prior to access to learning modules
Timepoint 2: Immediately after completion of learning modules
Timepoint 3: Eight weeks after completion of learning modules

Eligibility
Key inclusion criteria
Australian-registered physiotherapists
Proficiency in written and spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A convenience sample of 160 physiotherapists who have expressed interest in undertaking professional development training in RA using the RAP-eL resource will be invited to participate in the study.

A computer-generated program will randomly assign respondents to either the intervention or control group. This process will be undertaken by a person independent of the study data analysis.

Participants will be aware of the group to which are allocated. After the four week trial, members of the control group will be given access to the intervention.

Assessors and data analysts will be blind to participant allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of two groups using a computer-generated random binomial number sequence with equal allocation between the study groups.
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
Once the four week randomised control trial has been completed, data from all participants will be pooled to determine retention of knowledge at eight weeks after completion of the learning modules.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A convenience sample of 160 physiotherapists who have expressed interest in undertaking professional development training in RA using the RAP-eL resource will be invited to participate in the study. Analyses will be performed using SPSS version 19.0. A priori sample size calculations determined that a sample size of 128 would be sufficient to detect an effect size of 0.5 with a power of 80% and an alpha of 0.05. Estimating an attrition rate of approximately 25% we will collect expressions of interest from 160 physiotherapists.

For the 4-week RCT, differences between groups at baseline will be analysed using the t-test. Between group changes from baseline to four weeks will be examined using ANCOVA to allow adjustment for any differences identified at baseline, and 95% confidence intervals (95% CIs) will be provided.

For the cohort study paired t-tests will be performed to determine change in performance over time from immediate post RAP-eL to 8 weeks follow-up. p-values less than 0.05 will be considered significant.

Secondary analysis will determine the proportion of participants who felt satisfied with their management of people with RA at baseline compared with at 8 weeks using chi-square.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/07/2013
Actual
25/07/2013
Date of last participant enrolment
Anticipated
25/07/2013
Actual
25/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 287400 0
Charities/Societies/Foundations
Name [1] 287400 0
Arthritis Osteoporosis Western Australia
Country [1] 287400 0
Australia
Funding source category [2] 287401 0
University
Name [2] 287401 0
Curtin University of Technology
Country [2] 287401 0
Australia
Funding source category [3] 287402 0
Government body
Name [3] 287402 0
Department of Health, Western Australia
Country [3] 287402 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Briggs
Address
Curtin Health Innovation Research Institute
Parker Place
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 286141 0
Individual
Name [1] 286141 0
Dr Robyn Fary
Address [1] 286141 0
Curtin Health Innovation Research Institute
Parker Place
Bentley WA 6102
Country [1] 286141 0
Australia
Other collaborator category [1] 277443 0
Charities/Societies/Foundations
Name [1] 277443 0
Arthritis Osteoporosis Western Australia
Address [1] 277443 0
17 Lemnos Street
Shenton Park WA 6008
Country [1] 277443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289378 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289378 0
Ethics committee country [1] 289378 0
Australia
Date submitted for ethics approval [1] 289378 0
Approval date [1] 289378 0
04/06/2013
Ethics approval number [1] 289378 0
PT0192

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

Contacts
Principal investigator
Name 40538 0
Dr Andrew Briggs
Address 40538 0
Curtin Health Innovation Research Institute
Curtin University
Parker Place
Bentley WA 6102
Country 40538 0
Australia
Phone 40538 0
+61 8 9266 3313
Fax 40538 0
Email 40538 0
[email protected]
Contact person for public queries
Name 40539 0
Robyn Fary
Address 40539 0
School of Physiotherapy and Curtin Health Innovation Research Institute
Curtin University
Parker Place
Bentley WA 6102
Country 40539 0
Australia
Phone 40539 0
+61 8 9266 3313
Fax 40539 0
Email 40539 0
[email protected]
Contact person for scientific queries
Name 40540 0
Robyn Fary
Address 40540 0
School of Physiotherapy and Curtin Health Innovation Research Institute
Curtin University
Parker Place
Bentley WA 6102
Country 40540 0
Australia
Phone 40540 0
+61 8 9266 3313
Fax 40540 0
Email 40540 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePolicy-into-practice for rheumatoid arthritis: Randomized controlled trial and cohort study of E-learning targeting improved physiotherapy management.2015https://dx.doi.org/10.1002/acr.22535
N.B. These documents automatically identified may not have been verified by the study sponsor.