Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000422628
Ethics application status
Approved
Date submitted
14/04/2014
Date registered
17/04/2014
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two different online educational strategies for increasing students’ knowledge about physiotherapy management of spinal cord injury (SCI): a randomised controlled trial
Scientific title
Comparison of two different online educational strategies for increasing students’ knowledge about physiotherapy management of spinal cord injury (SCI): a randomised controlled trial
Secondary ID [1] 284411 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 291610 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291982 291982 0 0
Physiotherapy
Injuries and Accidents 292059 292059 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online Education through a Massive Open Online Course (MOOC)

Participants will be enrolled into a Massive Open Online Course (MOOC) titled: Physiotherapy Management of Spinal Cord Injuries. The course will run for 5 weeks.

Participants will be asked to devote 3 hours per week to the course. Participants will be given 3 tasks each week, namely:
1. Complete 2 to 3 of the lessons within the physiotherapy module of www.elearnSCI.org – these are part of freely available web-based elearn modules created by the International Spinal Cord Society
2. Look at additional readings, videos and resources
3. Contribute to an online discussion run through a closed facebook group.

The aim of the course is to equip physiotherapy students with sufficient knowledge to manage a person with SCI. This includes assessing impairments, activity limitations and participation restrictions, setting appropriate goals of treatment, formulating an evidence-based treatment plan, implementing treatment and evaluating its success.


Adherence to the course will not be directly supervised. However, participants will be emailed and encouraged to register and participate.
Intervention code [1] 289154 0
Rehabilitation
Comparator / control treatment
Online Education through web-based elearn modules


Participants will be asked to devote 3 hours per week for 5 weeks to learning about the Physiotherapy Management of People with SCI. However, they will not be enrolled in the Massive Open Online Course (MOOC).

Instead, they will be asked to move at their own pace over a 5-week period through the lessons within the physiotherapy module of www.elearnSCI.org – these are part of freely available web-based elearn modules created by the International Spinal Cord Society. This is the same module and same content that the experimental participants will be exposed to. However, in contrast to the experimental participants, the control participants will not be enrolled in the Massive Open Online Course (MOOC) and therefore will not look at additional readings, videos and resources, and will not contribute to an online discussion run through a closed facebook group. In addition, their movement through the content will not be paced.


The aim of the modules is to equip physiotherapy students with sufficient knowledge to manage a person with SCI. This includes assessing impairments, activity limitations and participation restrictions, setting appropriate goals of treatment, formulating an evidence-based treatment plan, implementing treatment and evaluating its success.

Adherence will not be directly supervised. However, participants will be emailed and encouraged to register for the online learning modules.
Control group
Active

Outcomes
Primary outcome [1] 291882 0
Knowledge about physiotherapy management of spinal cord injuries

Participants' knowledge will be assessed at the beginning and end of the trial through a 20-item multiple choice test. The test will be administered online in an exam situation with teacher supervision. Pairs of similar questions will be devised by the investigators prior to the commencement of the trial. Each question in each pair will then be randomly allocated to either the pre-trial test or the post-trial test.
Timepoint [1] 291882 0
6 weeks
Secondary outcome [1] 307730 0
Satisfaction with the learning experience

Participants' satisfaction with the learning experience will be assessed at the completion of the trial by asking participants to rate 4 statement on a 11-point numerical analogue scale anchored at one end with "strongly disagree" and at the other end with "strongly agree". This assessment will be administered online in an exam situation with teacher supervision.
Timepoint [1] 307730 0
6 weeks
Secondary outcome [2] 307731 0
Self-efficacy and confidence in providing physiotherapy services to people with spinal cord injury

Participants' self-efficacy and confidence in providing physiotherapy services to people with spinal cord injury will be assessed at the beginning and end of the trial by asking participants to rate 10 statement on a 11-point numerical analogue scale anchored at one end with "not confident" and at the other end with "highly confident". This assessment will be administered online in an exam situation with teacher supervision.
Timepoint [2] 307731 0
6 weeks

Eligibility
Key inclusion criteria
1. 2nd or 3rd year undergraduate physiotherapy students at the Bangladesh Health Professionals Institute
2. over 16 years of age and able to provide informed consent
3. willing to participate
4. regular internet access
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. insufficient English to complete the online modules or to provide consent

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)
2nd and 3rd year undergraduate physiotherapy students from the Bangladesh Health Professions Institute (BHPI) will be approached by their teachers and invited to participate in the study.
Allocation to groups will be concealed. So once a student is accepted onto the study and completes the baseline assessments, an independent person in Sydney will allocate each student to either the experimental or control condition. Each student will then be individually emailed and told their allocation. The teachers in Bangladesh will remain blinded to students' allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Students will be randomly allocated to one of two groups by an independent person. The allocation will be generated by computer using a stratified (2nd year student versus 3rd year student) and blocked randomisation schedule.
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
Data will be analysed using linear regression to determine mean between-group differences and corresponding 95% CI for each outcome.
A sample size of 48 will be used to determine a 4 point difference in knowledge. This assumes an alpha of 5%, SD of 5 points, power of 80%, dropout rate of 10% and correlation with baseline knowledge of 0.6

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2014
Actual
20/04/2014
Date of last participant enrolment
Anticipated
30/04/2014
Actual
28/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 5977 0
Bangladesh
State/province [1] 5977 0

Funding & Sponsors
Funding source category [1] 289060 0
University
Name [1] 289060 0
Bangladesh Health Professionals Institute
Country [1] 289060 0
Bangladesh
Funding source category [2] 289061 0
University
Name [2] 289061 0
University of Sydney
Country [2] 289061 0
Australia
Primary sponsor type
University
Name
Bangladesh Health Professionals Institute
Address
Centre for the Rehabilitation of the Paralysed
Savar
Dhaka 1343 Bangladesh
Country
Bangladesh
Secondary sponsor category [1] 287727 0
University
Name [1] 287727 0
University of Sydney
Address [1] 287727 0
Kolling Institute
C/O Royal North Shore Hospital
Pacific Highway
St Leonards, NSW, Australia, 2065
Country [1] 287727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290858 0
Centre for Rehabilitation of the Paralysed
Ethics committee address [1] 290858 0
Ethics committee country [1] 290858 0
Bangladesh
Date submitted for ethics approval [1] 290858 0
Approval date [1] 290858 0
16/04/2014
Ethics approval number [1] 290858 0

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

Contacts
Principal investigator
Name 47606 0
A/Prof Md. Shofiqul Islam
Address 47606 0
Department of Physiotherapy
Bangladesh Health Professions Institute (BHPI)
CRP-Chapain, Savar, Dhaka-1343
Country 47606 0
Bangladesh
Phone 47606 0
+88 01725 145973
Fax 47606 0
Email 47606 0
[email protected]
Contact person for public queries
Name 47607 0
Lisa Harvey
Address 47607 0
Kolling Institute
C/O Royal North Shore Hospital
Pacific Highway, St Leonards, NSW, Australia, 2065
Country 47607 0
Australia
Phone 47607 0
61299264594
Fax 47607 0
Email 47607 0
[email protected]
Contact person for scientific queries
Name 47608 0
Lisa Harvey
Address 47608 0
Kolling Institute
C/O Royal North Shore Hospital
Pacific Highway, St Leonards, NSW, Australia, 2065
Country 47608 0
Australia
Phone 47608 0
61299264594
Fax 47608 0
Email 47608 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
EmbaseA massive open online course (MOOC) can be used to teach physiotherapy students about spinal cord injuries: a randomised trial.2015https://dx.doi.org/10.1016/j.jphys.2014.09.008
N.B. These documents automatically identified may not have been verified by the study sponsor.