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Trial registered on ANZCTR


Registration number
ACTRN12615000283572
Ethics application status
Approved
Date submitted
23/10/2014
Date registered
25/03/2015
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of Electronic Visual Analogue Scales (VAS) for Subjective Measures in older adults in rehabilitation for musculoskeletal and neurological conditions; Pain, Fatigue, Exertion, Enjoyment and Perceived benefits
Scientific title
A comparison of the use of visual analogue scales using paper based and iPad based VAS for Pain, Fatigue, Exertion, Enjoyment and Perceived benefits in older adults in rehabilitation
Secondary ID [1] 285532 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults in rehabilitation for musculoskeletal conditions 293350 0
Older adults in rehabilitation for neurological conditions 294172 0
Condition category
Condition code
Musculoskeletal 293620 293620 0 0
Other muscular and skeletal disorders
Neurological 293621 293621 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 294500 294500 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Data will be collected once using a touch screen on an iPad device. Participants wil complete 4 screens using their finger on a touch screen and complete a VAS Pain, VAS fatigue, borg rating of exertion, plus a rating scale for enjoyment, perceived benefit and ease of use. It is anticipated that it would take 5 minutes to explain and complete
Intervention code [1] 290475 0
Diagnosis / Prognosis
Comparator / control treatment
Data will be collected once using a pen and paper resting on a clipboard. Participants wil complete 4 sheets of paper complete a VAS Pain, VAS fatigue, borg rating of extertion, plus a rating scale for enjoyment, perceived benefit and ease of use. It is anticipated that it would take 5 minutes to explain and complete.
Control group
Active

Outcomes
Primary outcome [1] 293426 0
Mean difference (in mm) and limits of agreement VAS pain
Timepoint [1] 293426 0
Baseline
Primary outcome [2] 294281 0
Mean difference (in mm) and limits of agreement VAS fatigue
Timepoint [2] 294281 0
baseline
Primary outcome [3] 294282 0
Mean difference and limits of agreement borg rating scale of perceived exertion
Timepoint [3] 294282 0
Baseline
Secondary outcome [1] 311008 0
Co-efficient of variation of the score on the VAS for pain and fatigue
Timepoint [1] 311008 0
baseline

Eligibility
Key inclusion criteria
Older adults attending for exercise class or rehabilitation for musculoskeletal or neurological conditions
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological conditions that impact on communication and prohibit informed consent to be made including
aphasia
dementia
cognitive impairment
vision

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants who attend exercise classes will be invited by the researchers to participate in the study. As this is a cross over trial, all participants will receive both interventions and randomisation will occur just prior to data collection. Participants and researchers will not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will draw a coloured chip from a hat (eyes closed) and select either a blue or red chip. Participants who draw a red chip will complete the paper scales first; participants who draw a blue chip will complete the electronic scales first.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis
Bland altman plots will be generated from the mean data to determine limits of agreement for the two methods of data collection (paper and iPad). As well, co-efficient of variation will be generated for the novel data collection tool - the iPad. Sample size is based on previous research examining validity of VAS for pain in acute care where scores on a VAS ranged from 0 to 100 and the standard deviation was 24.29 and correlation between electronic and visual scales 0.90. A sample size of 24 reported a power of 90% to detect a difference of 2.22 or greater.

Recruitment
Recruitment status
Completed
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)
TAS
Recruitment hospital [1] 3080 0
Launceston General Hospital - Launceston

Funding & Sponsors
Funding source category [1] 290142 0
University
Name [1] 290142 0
The University of Tasmania
Address [1] 290142 0
The School of Health Sciences
Locked Bag 1322
Launceston, 7250
Tasmania
Country [1] 290142 0
Australia
Primary sponsor type
University
Name
The University of Tasmania
Address
The School of Health Sciences
Locked Bag 1322
Launceston, 7250
Tasmania
Country
Australia
Secondary sponsor category [1] 288851 0
None
Name [1] 288851 0
Address [1] 288851 0
Country [1] 288851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291849 0
Tasmanian Health and Medical Research Ethics committee
Ethics committee address [1] 291849 0
Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 291849 0
Australia
Date submitted for ethics approval [1] 291849 0
Approval date [1] 291849 0
24/06/2014
Ethics approval number [1] 291849 0
H0014062

Summary
Brief summary
The aim of this study is determine if data collected on a mobile device has the same accuracy and reliability as the traditional paper based method of data collection. Data collection using mobile technology (including iPads) has the capacity to improve the efficiency of data collection and reduce transcription errors in large data sets.
Measurement of subjective measures such as Pain, Fatigue, Exertion, Enjoyment and Perceived benefits of an intervention allow researchers to determine valuable information, from the perspective of the participants, in any intervention that they are carrying out. These factors have been identified as important barriers or facilitators to participation in in physical activity or exercise programs. Tools to measure these parameters have been validated in paper form. In larger studies the ability to collect this data electronically has huge potential to improve research efficiency, but to date no validation studies have been done using the iPad and these tools in an older population. Advantages:
*Reduced time for data collection
*Improved storage of data (no paper copies required)
*Reduced research time (no data transcription required)
*Easy ability to securely gain and store de-identified/re-identifiable data
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 52246 0
Dr Marie-Louise Bird
Address 52246 0
The Faculty of Health
University of Tasmania
Locked Bag 1322
Launceston 7250
Tasmania
Country 52246 0
Australia
Phone 52246 0
+61 3 63425497
Fax 52246 0
Email 52246 0
birdm@utas.edu.au
Contact person for public queries
Name 52247 0
Dr Marie-Louise Bird
Address 52247 0
The Faculty of Health
University of Tasmania
Locked Bag 1322
Launceston 7250
Tasmania
Country 52247 0
Australia
Phone 52247 0
+61 3 63425497
Fax 52247 0
Email 52247 0
birdm@utas.edu.au
Contact person for scientific queries
Name 52248 0
Dr Marie-Louise Bird
Address 52248 0
The Faculty of Health
University of Tasmania
Locked Bag 1322
Launceston 7250
Tasmania
Country 52248 0
Australia
Phone 52248 0
+61 3 63425497
Fax 52248 0
Email 52248 0
birdm@utas.edu.au

No information has been provided regarding IPD availability
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