Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001292369
Ethics application status
Approved
Date submitted
16/06/2017
Date registered
7/09/2017
Date last updated
16/12/2020
Date data sharing statement initially provided
12/08/2019
Date results information initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a multi-faceted web based resource on spinal health literacy in patients with low back pain - a randomised controlled trial
Scientific title
Efficacy of a multi-faceted web based resource on spinal health literacy in patients with low back pain - a randomised controlled trial
Secondary ID [1] 291934 0
None.
Universal Trial Number (UTN)
U1111-1196-6323
Trial acronym
None.
Linked study record
Not applicable.

Health condition
Health condition(s) or problem(s) studied:
Low back pain. 303267 0
Condition category
Condition code
Musculoskeletal 302694 302694 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a multifaceted web-based resource for individuals with low back pain - MyBackPain, which integrates evidence-based LBP information and explicitly considers the needs and preferences of people with LBP. Participants will be given access to the website for a period of 3 months, Access to the information will be in multiple ways: self-directed browsing and searching of the content; guided content tailored to the features of their presentation and identified information priorities; and the opportunity to “opt-in” to receive regular e-mails (at a frequency selected by the participant - i.e. weekly, fortnightly or monthly) that highlight key messages about LBP. Regular email "opt-in" and "opt-out" will be available at any time during the 3-month intervention period to all participants. Intervention adherence will be assessed by website access statistics as participants will be given login details enabling their usage of the site to be recorded.

The MyBackPain website was designed by researchers from the University of Queensland, University of Sydney and in partnership with Arthritis Australia. Its design was based on the amalgamation of international clinical practice guidelines, an international  expert committee and extensive consultation with consumers.
Intervention code [1] 298055 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will be instructed that we would like them to search the internet for information about LBP and that they should record the websites they have visited over the three-month period. They will not have access to MyBackPain website until it is launched to the public.
Control group
Active

Outcomes
Primary outcome [1] 302094 0
Primary outcome will be the spinal health literacy evaluation measured with the Health Literacy Questionnaire. The HLQ includes 44 items and nine dimensions. Dimensions 2 and 3 will be included as co-primary outcome measures: having sufficient information to manage my health and actively managing my health. The two dimensions will be assessed using a 4-point Likert scale (1 completely disagree; 4 completely agree) and a 0-100 score will be presented for each dimension.
Timepoint [1] 302094 0
Primary outcomes will be assessed at 1, 3, 6 and 12 months, with 3 months being the primary endpoint for the trial.
Secondary outcome [1] 334728 0
Quality of treatment preference (observed) Patient decision-making will be measured by evaluation of observed treatment choices. Treatments used by the participant during the follow-up period will be scored against the recommendations provided in the MyBackPain website, and based on a 5-point rating: “good evidence”, “may work”, “not enough evidence”, “unlikely to work” and “may be harmful”.
Timepoint [1] 334728 0
1, 3, 6 and 12 months.
Secondary outcome [2] 334729 0
Average pain in the last week (VAS).
Timepoint [2] 334729 0
1, 3, 6 and 12 months.
Secondary outcome [3] 334730 0
Disability - Roland Morris Disability questionnaire.
Timepoint [3] 334730 0
1, 3, 6 and 12 months.
Secondary outcome [4] 334731 0
Quality of life will be measured with the SF36 (short form).
Timepoint [4] 334731 0
1, 3, 6 and 12 months.
Secondary outcome [5] 336050 0
Spinal health literacy will be evaluated with items 1, 4-9 of the Health Literacy Questionnaire.
Timepoint [5] 336050 0
1, 3, 6 and 12 months.
Secondary outcome [6] 338114 0
Quality of treatment preference (stated)
Patient decision-making will be measured by evaluation of stated likelihood of treatment choices. Patients will be asked to present on a 5-point scale (very reasonable, reasonable, neither reasonable nor unreasonable, unreasonable, very unreasonable) how reasonable it would be for someone to consider a subset of treatments discussed in the MyBackPain website. Treatment choices will be scored against the recommendations provided in the MyBackPain website, and based on a 5-point rating: “good evidence”, “may work”, “not enough evidence”, “unlikely to work” and “may be harmful”.
Timepoint [6] 338114 0
1, 3, 6 and 12 months.

Eligibility
Key inclusion criteria
Current low back pain – any duration, diagnosis, presentation
At least 18 years of age, but no upper age limit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No access to the internet
Inability to understand English
Any known or diagnosed specific spinal pathology (e.g. fracture, cancer, infection, nerve root compromise)

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)
Central, computerized randomisation will be used to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Randomisation will be stratified by symptom duration (i.e. less than 6 weeks duration with at least 1 month without symptoms (acute); more than 6 weeks duration or less than 6 weeks but without 1 month symptom-free (chronic)).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation is based on an effect size of 0.30, for having sufficient information to manage my health and actively managing my health dimensions of the HLQ. A sample size of 440 (75% chronic) participants will achieve 80% power to detect the desired effect size, allowing for a conservative loss to follow-up rate of 20% at three months.
Analyses will be by intention-to-treat analysis of all randomised patients. The primary outcome and other continuous outcomes will be analysed using longitudinal linear regression models, with outcomes measured at 1, 3, 6 and 12 months as outcomes in the model, adjusting for baseline values of outcomes and an interaction between month and randomised group included as fixed effects, with random effects for participants. Similar longitudinal logistic regression models will be used for binary outcomes. These models will be interrogated to yield differences between groups at each time point. Standard diagnostic plots will be used to assess regression assumptions. Descriptive statistics on demographics and clinical characteristics will be presented for each group as the mean change (standard deviation, 95% confidence intervals) or counts and percentages for categorical variables. Multiple imputation methodology will be employed to account for missing data. No statistical adjustment will be made for multiple testing. All tests will be carried out at the 5% level of significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2017
Actual
6/12/2017
Date of last participant enrolment
Anticipated
19/03/2018
Actual
16/01/2019
Date of last data collection
Anticipated
16/01/2020
Actual
20/01/2020
Sample size
Target
440
Accrual to date
Final
440
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296441 0
Government body
Name [1] 296441 0
National Health and Medical Research Council
Country [1] 296441 0
Australia
Funding source category [2] 296747 0
Commercial sector/Industry
Name [2] 296747 0
Medibank Health Research Fund
Country [2] 296747 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 295392 0
None
Name [1] 295392 0
Not applicable
Address [1] 295392 0
Not applicable
Country [1] 295392 0
Other collaborator category [1] 279568 0
University
Name [1] 279568 0
The University of Sydney
Address [1] 279568 0
The University of Sydney
Camperdown NSW 2006
Country [1] 279568 0
Australia
Other collaborator category [2] 279569 0
University
Name [2] 279569 0
The University of Melbourne
Address [2] 279569 0
The University of Melbourne
Parkville VIC 3010
Country [2] 279569 0
Australia
Other collaborator category [3] 279570 0
Charities/Societies/Foundations
Name [3] 279570 0
Arthritis Australia
Address [3] 279570 0
2/255 Broadway, Glebe NSW 2037
Country [3] 279570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297671 0
Human Research Ethics Committee, University of Queensland
Ethics committee address [1] 297671 0
Brisbane St Lucia, QLD 4072
Ethics committee country [1] 297671 0
Australia
Date submitted for ethics approval [1] 297671 0
04/07/2017
Approval date [1] 297671 0
25/08/2017
Ethics approval number [1] 297671 0
2017000995

Summary
Brief summary
We have developed a comprehensive LBP website in collaboration with Arthritis Australia, the peak national consumer organisation for individuals with musculoskeletal pain. The website integrates evidence-based LBP information, tailored guidance and explicitly considers the needs and preferences of people with LBP. We currently seek to evaluate the website in a randomised controlled trial to measure its effect on health literacy, treatment choices and clinical outcomes. This step is vital before dissemination of the website can occur.
Trial website
Not applicable.
Trial related presentations / publications
Not applicable.
Public notes
Not applicable.

Contacts
Principal investigator
Name 74762 0
Prof Paul Hodges
Address 74762 0
School of Health and Rehabilitation Sciences
Faculty of Health and Behavioural Sciences
The University of Queensland
Brisbane St Lucia, QLD 4072
Country 74762 0
Australia
Phone 74762 0
+61 7 336 52008
Fax 74762 0
Email 74762 0
[email protected]
Contact person for public queries
Name 74763 0
Prof Paul Hodges
Address 74763 0
School of Health and Rehabilitation Sciences
Faculty of Health and Behavioural Sciences
The University of Queensland
Brisbane St Lucia, QLD 4072
Country 74763 0
Australia
Phone 74763 0
+61 7 336 52008
Fax 74763 0
Email 74763 0
[email protected]
Contact person for scientific queries
Name 74764 0
Prof Paul Hodges
Address 74764 0
School of Health and Rehabilitation Sciences
Faculty of Health and Behavioural Sciences
The University of Queensland
Brisbane St Lucia, QLD 4072
Country 74764 0
Australia
Phone 74764 0
+61 7 336 52008
Fax 74764 0
Email 74764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3926Study protocolHall LM, Ferreira M, Setchell J, French S, Kasza J, Bennell KL, et al. MyBackPain-evaluation of an innovative consumer-focused website for low back pain: study protocol for a randomised controlled trial. BMJ Open. 2019;9(5):e027516  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMyBackPain - Evaluation of an innovative consumer-focused website for low back pain: Study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-027516
EmbaseEffect of a consumer-focused website for low back pain on health literacy, Treatment choices, and clinical outcomes: Randomized controlled trial.2021https://dx.doi.org/10.2196/27860
EmbaseTelehealth treatment for nonspecific low back pain: A review of the current state in mobile health.2022https://dx.doi.org/10.1002/pmrj.12738
N.B. These documents automatically identified may not have been verified by the study sponsor.