Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000947606
Ethics application status
Approved
Date submitted
27/08/2014
Date registered
4/09/2014
Date last updated
11/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a mouldable writing aid on older adults with hand osteoarthritis: a randomised controlled trial.
Scientific title
In patients with hand osteoarthritis, does using a mouldable writing aid compared to a commercial alternative improve handwriting speed, legibility and pain?
Secondary ID [1] 285223 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand osteoarthritis 292852 0
Condition category
Condition code
Musculoskeletal 293153 293153 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be issued with a mouldable pen (designed at Unitec) to use for 8 weeks.
The researcher will show the participant how to mould the pen initially. It can then "set" into shape or be re-moulded if the participant wishes.
The pen has a latex exterior, the design of the internal contents are the intellectual property of the designer and Unitec Institute of Technology.
Participants are asked to use the pen as they would a normal pen and to note when they use it.
Intervention code [1] 290097 0
Treatment: Devices
Comparator / control treatment
Participants will be issued with a commercially available pen (the PenAgainTM) to use for 8 weeks. The PenAgainTM is available worldwide. It has a patented wishbone shaped design and has been ergonomically developed to fit to the contours of the hand. Use of this pen may help alleviate the symptoms of Writers Cramp, Carpal Tunnel Syndrome, Calluses, RSI, and Arthritis.
Control group
Active

Outcomes
Primary outcome [1] 293021 0
Writing quality as measured by the Handwriting Assessment Battery for adults (McCluskey & Lannin, 2003).
Timepoint [1] 293021 0
Baseline and 8 weeks after intervention commencement.
Secondary outcome [1] 310169 0
Modified Health Assessment Questionnaire - to measure quality of life for those with arthritis.
Timepoint [1] 310169 0
Baseline and 8 weeks after intervention commencement.
Secondary outcome [2] 310170 0
Count of joints affected by osteoarthritis of the hand. Hands will be examined for the occurrence of bony enlargements (1= present, 0= absent) and will be calculated as a summary of signs in both hands (range 0 to 30). The American College of Rheumatology criteria (Altman et al., 1990) will also be used as a diagnosis confirmation of hand osteoarthritis.
Timepoint [2] 310170 0
Baseline and 8 weeks after intervention commencement.
Secondary outcome [3] 310171 0
Australian/Canadian hand index (AUSCAN) - self reported Likert scales for hand pain, stiffness and physical functioning.
Timepoint [3] 310171 0
Baseline and 8 weeks after intervention commencement.
Secondary outcome [4] 310172 0
Measure of Assistive Technology use scale- Likert scale assessing use of devices and 100mm VAS scale for comfort with assistive technology.
Timepoint [4] 310172 0
Baseline and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Osteoarthritis in writing hand.
Reside in Auckland, NZ.
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairments that may affect their ability to perform a handwriting assessment.
Hand surgery within the last six months.
Current treatment with cortisone.
Latex allergy.

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)
Allocation of treatment will be done by a sticker concealed in an opaque envelope (prepared by an administrative assistant not involved in the trial).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - coin tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the Handwriting Assessment Battery for adults (HAB) legibility data from a pilot trial (by the same researcher) - baseline data from the writing aid was 76.5% accuracy (SD=13.9). A 15% change would require 24 people in each group, whereas a 20% changes would require 13 people in each group. Using HAB lower case writing data form the pilot study - baseline data from the writing-aid was 80.6% accuracy (SD=12.91). A 10% change would require 41 in each group, whereas a 15% change would require 18 people in each group. Taking these into account,a sample size of 40 people (20 per group) was chosen as being statistically justified and realistically attainable.

All analysis will be performed on an intention to treat basis and based on the aggregated data for each allocated group. Paired Student’s t-tests will be used to identify the differences at baseline and follow-up between the two pen allocation groups. Differences within the groups will also be analysed by paired samples Student’s t-tests. To account for differences in baseline the change from baseline in each group will be compared. Distributions will be examined for normality and parametric and non-parametric tests will be applied as required. In the case of data that are not normally distributed the Mann-Whitney test, which is suitable for independent samples, will be used. All of the endpoints will be continuous quantitative data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2014
Actual
7/09/2014
Date of last participant enrolment
Anticipated
28/11/2014
Actual
23/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 6314 0
New Zealand
State/province [1] 6314 0
Auckland

Funding & Sponsors
Funding source category [1] 289856 0
University
Name [1] 289856 0
Unitec Institute of Technology
Country [1] 289856 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Private Bag 92025
Victoria St West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288538 0
None
Name [1] 288538 0
Address [1] 288538 0
Country [1] 288538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291579 0
Unitec Research Ethics Committee
Ethics committee address [1] 291579 0
139 Carrington Road
Mt Albert
Auckland 1025

Postal:
Private Bag 92025
Victoria St West
Auckland 1142
Ethics committee country [1] 291579 0
New Zealand
Date submitted for ethics approval [1] 291579 0
06/08/2014
Approval date [1] 291579 0
21/08/2014
Ethics approval number [1] 291579 0
2014-1073

Summary
Brief summary
Our hypothesis is that patients with moderate to severe arthritis of the hands will find the new writing-aid easier to use and therefore easier to write with. The aim of this study is to trial the writing-aid in clinical practice, with two distinct clear research questions in mind:
1. Is the participants’ handwriting improved with the writing-aid compared to a commercially available aid?
2. Do the participants find the writing-aid comfortable and easy to use?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50934 0
Ms Jesse Dyer
Address 50934 0
Unitec Institute of Technology
Private Bag 92025
Victoria St West
Auckland 1142

Attn: Helen Au Yeung
Faculty of Social and Health Sciences
Country 50934 0
New Zealand
Phone 50934 0
+64 9 8154321
Fax 50934 0
Email 50934 0
[email protected]
Contact person for public queries
Name 50935 0
Ms Jesse Dyer
Address 50935 0
Unitec Institute of Technology
Private Bag 92025
Victoria St West
Auckland 1142

Attn: Helen Au Yeung
Faculty of Social and Health Sciences
Country 50935 0
New Zealand
Phone 50935 0
+64 9 8154321
Fax 50935 0
Email 50935 0
[email protected]
Contact person for scientific queries
Name 50936 0
Ms Jesse Dyer
Address 50936 0
Unitec Institute of Technology
Private Bag 92025
Victoria St West
Auckland 1142

Attn: Helen Au Yeung
Faculty of Social and Health Sciences
Country 50936 0
New Zealand
Phone 50936 0
+64 9 8154321
Fax 50936 0
Email 50936 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
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