Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001319763
Ethics application status
Approved
Date submitted
21/11/2013
Date registered
27/11/2013
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
My Back on Track, My Future: developing culturally appropriate information for Aboriginal people with low back pain
Scientific title
Does culturally appropriate low back pain information improve the beliefs and perceptions of Aboriginal adults when compared to conventional low back pain information: the My Back on Track, My Future project.
Secondary ID [1] 283520 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 290439 0
Condition category
Condition code
Musculoskeletal 290963 290963 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Culturally appropriate low back pain information presented as audiovisual scenarios. There are five scenarios, each 3-7 minutes long. they will be administered on a laptop computer, ipad or played on a TV screen.
This is a crossover trial - participants will be randomised to intervention/control group and crossover after post intervention testing (time 1). Washout period will be minimal - 15 minutes.
Intervention code [1] 288325 0
Other interventions
Comparator / control treatment
Traditional form of low back pain information - 'The Back Book'. The Back Book is a 23 page consumer information resource. It contains evidence based information about low back pain. It differs from the intervention in mode of delivery (brochure versus audiovisual) and style (the Back Book is information/fact based rather than presenting as an enacted scenario).
Control group
Active

Outcomes
Primary outcome [1] 290943 0
Low back pain beliefs - assessed using an adapted version of the Back Pain Beliefs Questionnaire (BBQ). The BBQ has been adapted so the language is appropriate to the audience.
Timepoint [1] 290943 0
Pre-intervention and post interventions 1 and 2
Primary outcome [2] 290944 0
Perceived self-efficacy to manage low back pain - measured using a single item low back pain self-efficacy question and rating scale.
Timepoint [2] 290944 0
Pre-intervention and post interventions 1 and 2
Secondary outcome [1] 305637 0
Number of scenarios watched and number of pagers read of traditional information - as reported by participants
Timepoint [1] 305637 0
Will be assessed after each intervention. This is a crossover trial so following the intervention and following the control i.e. time 1 and time 2.
Secondary outcome [2] 305638 0
perceptions about information assessed qualitatively. Qualitative interviews will be used to determine perceptions about quality and usefulness of the resource and participant perceptions about low back pain management
Timepoint [2] 305638 0
post interventions 1 and 2

Eligibility
Key inclusion criteria
Aboriginal adults. Consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to read written English.
Inability to communicate verbally.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/2013
Actual
6/01/2014
Date of last participant enrolment
Anticipated
Actual
7/03/2014
Date of last data collection
Anticipated
Actual
7/03/2014
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288319 0
Government body
Name [1] 288319 0
National Health and Medical Research Council
Country [1] 288319 0
Australia
Primary sponsor type
University
Name
Combined Universities Centre for Rural Health, the University of Western Australia
Address
PO Box 109
Geraldton
Western Australia 6531
Country
Australia
Secondary sponsor category [1] 287036 0
Government body
Name [1] 287036 0
Geraldton Regional Aboriginal Medical Service
Address [1] 287036 0
P.O Box 4109, Rangeway, Geraldton, WA, 6530
Country [1] 287036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290214 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 290214 0
Ethics committee country [1] 290214 0
Australia
Date submitted for ethics approval [1] 290214 0
Approval date [1] 290214 0
17/10/2013
Ethics approval number [1] 290214 0
522

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

Contacts
Principal investigator
Name 44098 0
Dr Ivan Lin
Address 44098 0
Combined Universities Centre for Rural Health
PO Box 109
Geraldton
western Australia 6531
Country 44098 0
Australia
Phone 44098 0
+61 8 99560200
Fax 44098 0
Email 44098 0
[email protected]
Contact person for public queries
Name 44099 0
Ivan Lin
Address 44099 0
Combined Universities Centre for Rural Health
PO Box 109
Geraldton
western Australia 6531
Country 44099 0
Australia
Phone 44099 0
+61 8 99560200
Fax 44099 0
Email 44099 0
[email protected]
Contact person for scientific queries
Name 44100 0
Ivan Lin
Address 44100 0
Combined Universities Centre for Rural Health
PO Box 109
Geraldton
western Australia 6531
Country 44100 0
Australia
Phone 44100 0
+61 8 99560200
Fax 44100 0
Email 44100 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
No additional documents have been identified.