Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000656538p
Ethics application status
Not yet submitted
Date submitted
15/04/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of an online decision aid in improving understanding of opioid use in the management of lower back pain (LBP) and osteoarthritis (OA)
Scientific title
Efficacy of an online decision aid in improving understanding of opioid use in the management of lower back pain (LBP) and osteoarthritis (OA) in adults aged 50 years and over
Secondary ID [1] 311969 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 333573 0
Hip osteoarthritis 333574 0
Knee osteoarthritis 333575 0
Condition category
Condition code
Musculoskeletal 330258 330258 0 0
Osteoarthritis
Musculoskeletal 330259 330259 0 0
Other muscular and skeletal disorders
Public Health 330351 330351 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will receive two short videos (<90 seconds each) viewed in succession developed specifically for this study and informed by the content from the TANGO (TAperiNG of Opioids in older adults) brochure (Marcelo et al, 2023). The first video will address opioid risks and benefits, and how to reduce opioid use. The second video will address non-pharmacological pain management strategies such as a healthy lifestyle with regular physical activity and a healthy balanced diet, physiotherapy and pain and stress management, and resources for further information. The content of the videos has been assessed and approved by health practitioners and consumers for credibility, acceptability and readability. The videos are educational only and will explicitly encourage viewers not to change their medication use before consulting with physician. Adherence to the intervention will be monitored via REDCap analytics to ensure participants are watching the full length of the videos.

Once the consent form is completed, participants will be randomly assigned to either the intervention or control group. Participants will then be led to view either the intervention or control video via REDCap. Once the video is viewed, the post-video survey will be shown.
Intervention code [1] 328430 0
Behaviour
Comparator / control treatment
Participants in the control arm will receive an attention control video on LBP, hip, or knee OA management. This video is freely available on YouTube via this link: https://www.youtube.com/watch?v=jIwn9rC3rOI. The attention control video was selected as it has a similar length to the intervention arm videos combined but does not contain information specific to opioid use. It also provides similar educational information about self-management options albeit for chronic non-cancer pain instead of LBP or hip or knee OA specifically. These include: assessment and ruling out serious conditions, psychosocial management, finding meaningful activities and support networks, sleep and physical activity, and good nutrition.

Strategies to monitor adherence to the attention control video include utilising REDCap analytics to monitor the length of time spent watching the videos. In addition a study-specific questionnaire will ask participants questions around their knowledge of treatment options, medication use and physical activity for managing LBP or hip or knee OA.
Control group
Active

Outcomes
Primary outcome [1] 338002 0
Behavioural intent
Timepoint [1] 338002 0
This outcome will be assessed before and after participants watch the two intervention videos or the one attention control video depending on if they have been randomly allocated to the intervention or the control arm.
Secondary outcome [1] 434085 0
Knowledge of management options
Timepoint [1] 434085 0
This outcome will be assessed before and after participants watch the two intervention videos or the one attention control video depending on if they have been randomly allocated to the intervention or the control arm.
Secondary outcome [2] 434086 0
Attitudes towards opioid medications
Timepoint [2] 434086 0
This outcome will be assessed before and after participants watch the two intervention videos or the one attention control video depending on if they have been randomly allocated to the intervention or the control arm.
Secondary outcome [3] 434087 0
Likelihood of making an informed decision
Timepoint [3] 434087 0
This outcome will be assessed before and after participants watch the two intervention videos or the one attention control video depending on if they have been randomly allocated to the intervention or the control arm.

Eligibility
Key inclusion criteria
To be included participants must meet the following inclusion criteria:
• Aged 50 years or above, and;
• Living in Australia, and;
• Currently experiencing LBP, or;
• Having been diagnosed with hip, or knee OA by a medical professional.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if any of the following are present:
• Unable to complete questionnaires in English;
• Spinal surgery or joint replacement in the past 12 months;
• Using opioid medication for other reasons apart from musculoskeletal pain.

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)
Participants will be randomly assigned to either the intervention or control group using a computer-generated randomisation tool within REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse participant demographics and outcome data providing means and standard deviations (SD) or medians and interquartile ranges (IQR). Two-sample t-tests and Chi2 tests will be utilised to assess baseline differences for continuous and categorical data respectively. Continuous outcomes will be analysed using linear regression models to determine between-group mean differences (MD) and 95% confidence intervals (CI). The effect of the intervention on dichotomous outcomes will be assessed using logistic regression models and presented as odds rations (OR) and 95% CI. These analyses will be adjusted for baseline values including current medication use (chosen a priori) and will be performed as per intention-to-treat.
To explore potential treatment effect heterogeneity, current use of opioids and symptom duration (i.e. less than 3 months or more than or equal to 3 months) will be included in the analyses described above as a treatment effect modifier. Subgroup analyses will be conducted to examine the intervention's effectiveness. Linear and logistic regression models will be used to assess between-group differences in continuous and dichotomous outcomes, respectively, within each subgroup (opioid users vs. non-opioid users; less than 3 months or more than or equal to 3 months symptom duration). All analyses will be conducted using jamovi (version 2.5).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/06/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316315 0
University
Name [1] 316315 0
University of Sydney
Country [1] 316315 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318498 0
None
Name [1] 318498 0
Address [1] 318498 0
Country [1] 318498 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315129 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315129 0
Ethics committee country [1] 315129 0
Australia
Date submitted for ethics approval [1] 315129 0
24/05/2024
Approval date [1] 315129 0
Ethics approval number [1] 315129 0

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

Contacts
Principal investigator
Name 133758 0
Prof Manuela Ferreira
Address 133758 0
Level 10, Kolling Institute, 10 Westbourne St, St Leonards, NSW, 2065
Country 133758 0
Australia
Phone 133758 0
+61 2 9463 1897
Fax 133758 0
Email 133758 0
manuela.ferreira@sydney.edu.au
Contact person for public queries
Name 133759 0
Alessandra Marcelo
Address 133759 0
Level 10, Kolling Institute, 10 Westbourne St, St Leonards, NSW, 2065
Country 133759 0
Australia
Phone 133759 0
+61 416388836
Fax 133759 0
Email 133759 0
alessandra.marcelo@sydney.edu.au
Contact person for scientific queries
Name 133760 0
Alessandra Marcelo
Address 133760 0
Level 10, Kolling Institute, 10 Westbourne St, St Leonards, NSW, 2065
Country 133760 0
Australia
Phone 133760 0
+61 416388836
Fax 133760 0
Email 133760 0
alessandra.marcelo@sydney.edu.au

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?

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.