Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001120662
Ethics application status
Approved
Date submitted
13/10/2014
Date registered
22/10/2014
Date last updated
22/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Text message based intervention for ongoing support and education of whiplash associated disorder among people with injury in a land transport crash
Scientific title
Feasibility of Text message based intervention for ongoing support and education of whiplash associated disorder among people with injury in a land transport crash
Secondary ID [1] 285484 0
None
Universal Trial Number (UTN)
Trial acronym
TEXT WAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Whiplash 293270 0
Condition category
Condition code
Injuries and Accidents 293536 293536 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 293585 293585 0 0
Other physical medicine / rehabilitation
Musculoskeletal 293623 293623 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Text message based intervention for improving health outcomes like pain intensity, whiplash associated disorder(WAD) related disability, self-efficacy, function and quality of life in people with chronic WAD.
The content of text messages will be developed through qualitative methods of in-depth interviews of stakeholders like physiotherapists, rehabilitation specialists, general physicians, patients with chronic whiplash.
Text messages will be sent twice every week for a period of 12 weeks in addition to usual care
Text messages are not yet developed, and are part of stakeholder consultation. However they will be n line with National Health and Medical Research Council guidelines. For example :"Collar immobilisation should not be undertaken with chronic whiplash."
"Prescribed rest is not recommended for chronic whiplash."
" Stay active on your way to recovery"
Intervention code [1] 290423 0
Rehabilitation
Comparator / control treatment
The control group will be participants with chronic whiplash ( that is more than 12 weeks but less than 12 months). They will continue on any treatment with physiotherapists, rehabilitation specialists, pain, chiropractor or psychologist consultancy/treatment they may be seeking for the condition.
Control group
Active

Outcomes
Primary outcome [1] 293359 0
Neck disability index
Timepoint [1] 293359 0
End of 12 weeks
Secondary outcome [1] 310838 0
Pain- using numeric pain rating scale of 0-10
Timepoint [1] 310838 0
End of 12 weeks
Secondary outcome [2] 310839 0
Quality of life-SF12
Timepoint [2] 310839 0
End of 12 weeks
Secondary outcome [3] 310840 0
Psychological health - DASS 21
Timepoint [3] 310840 0
End of 12 weeks
Secondary outcome [4] 310851 0
Qualitative interviews to assess acceptability of intervention
Timepoint [4] 310851 0
End of 12 weeks
Secondary outcome [5] 311019 0
Patient efficacy scale - validated scale
Timepoint [5] 311019 0
End of 12 weeks
Secondary outcome [6] 311020 0
Global perceived effect
Timepoint [6] 311020 0
End of 12 weeks
Secondary outcome [7] 311021 0
Patient Specific Functioning Scale
Timepoint [7] 311021 0
End of 12 weeks

Eligibility
Key inclusion criteria
1) Aged above 17 years
2) Neck pain beyond 12 weeks of road crash
3) Owns a mobile phone
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participation in any other research for improving health outcomes after land transportation injury

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)
Potential and interested participants will be informed about the trial both verbally and in writing using a participant information sheet (PIS) as per the Good Clinical Practices guidelines. Participants will be given the opportunity to ask any question and discuss their participation with their doctor and family. Verbal consent will be sought. Participants will be randomly allocated to intervention or control arm using secure computer-assisted method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified by gender. Telephone numbers will be used as a method of randomisation through a computer aided system which will be conducted an independent person located off the study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat principle will be followed and characteristics will be compared between the groups using independent t-tests or chi-square tests as appropriate. The mean level of each risk factor between groups will also be compared in terms of relative risks, 95% confidence intervals and two-sided p-values for achieving the guideline level of each risk factor.
This is a pilot project 30% of the original sample for RCT powered at 90% has been considered

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
Date of last participant enrolment
Anticipated
15/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290087 0
Government body
Name [1] 290087 0
Motor Accidents Authority of New South Wales, Australia
Country [1] 290087 0
Australia
Primary sponsor type
Individual
Name
Dr Jagnoor Jagnoor
Address
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 288786 0
Individual
Name [1] 288786 0
Prof. Ian Cameron
Address [1] 288786 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country [1] 288786 0
Australia
Other collaborator category [1] 278194 0
Individual
Name [1] 278194 0
Dr. Trudy Rebbeck
Address [1] 278194 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country [1] 278194 0
Australia
Other collaborator category [2] 278195 0
Individual
Name [2] 278195 0
Dr Bamini Gopinath
Address [2] 278195 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country [2] 278195 0
Australia
Other collaborator category [3] 278196 0
Individual
Name [3] 278196 0
Assistant Prof. Ashley Craig
Address [3] 278196 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country [3] 278196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291795 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 291795 0
Level 2 Margaret Telfer Building K07, The University of Sydney, NSW. 2006
Ethics committee country [1] 291795 0
Australia
Date submitted for ethics approval [1] 291795 0
25/09/2014
Approval date [1] 291795 0
10/10/2014
Ethics approval number [1] 291795 0
2014/779

Summary
Brief summary
Whiplash-associated disorder (WAD) represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. Chronic WAD is a bio-psycho-social condition. And though education is an effective intervention for people with WAD, providing access to such interventions is a major challenge. The randomised control trial aims to investigate whether simple reminders about self-management sent via mobile phone text message improves health outcomes in people with chronic WAD.

This is pilot for a randomised controlled trial with three months follow-up to evaluate the feasibility, acceptability and effect on health outcomes of repeated reminders sent via mobile phone text messages compared to usual care. A total of 50 patients, with chronic WAD will be randomised to either standard care or the TEXT WAD intervention. The participants will be identified through Personal Injury Registry, Motor Accident Authority, NSW. The intervention group will receive two weekly text messages that provide information, reassurance, support, and recommendations for “act usual” and physical activity. The primary endpoint is change in score of Neck Disability Index. Process outcomes related to acceptability and feasibility of TEXT WAD will also be collected. Text messaging has potential as a cheap, safe and simple method to support and educate people with chronic WAD. However, its effectiveness and feasibility in practice must be proven in a well-designed and rigorously conducted trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52054 0
Dr Jagnoor Jagnoor
Address 52054 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country 52054 0
Australia
Phone 52054 0
+61 450 161 295
Fax 52054 0
Email 52054 0
[email protected]
Contact person for public queries
Name 52055 0
Dr Jagnoor Jagnoor
Address 52055 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country 52055 0
Australia
Phone 52055 0
+61 450 161 295
Fax 52055 0
Email 52055 0
[email protected]
Contact person for scientific queries
Name 52056 0
Dr Jagnoor Jagnoor
Address 52056 0
Level 13,Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
Northern Sydney Local Health District
St Leonards NSW 2065
Country 52056 0
Australia
Phone 52056 0
+61 450 161 295
Fax 52056 0
Email 52056 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

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