Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001490763
Ethics application status
Approved
Date submitted
21/11/2022
Date registered
29/11/2022
Date last updated
15/04/2024
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
MOOC-OA: A consumer-focused Massive Open Online Course about osteoarthritis and its management: a randomised controlled trial
Scientific title
Effects of a consumer-focused Massive Open Online Course on consumer knowledge about osteoarthritis management and pain self-efficacy: a randomised controlled trial
Secondary ID [1] 308396 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 328197 0
Hip osteoarthritis 328316 0
Condition category
Condition code
Musculoskeletal 325251 325251 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this two-arm, parallel-design, superiority, randomised controlled trial, participants randomised to the intervention group will receive access to a 4-module consumer-focused Massive Open Online Course (MOOC) about osteoarthritis (OA) and its management.

After randomisation, participants will receive an email from the research team, which contains details of how to access the course online. Participants will be asked to access the course at home, on their own device and complete module 1 within 7 days of enrolling in the course. Thereafter, they will be encouraged to complete 1 module per week and will be given 5 weeks to complete all 4 modules.

The consumer-focused MOOC contains educational information about OA and its management that aligns with best evidence/clinical guideline recommendations for hip/knee OA.

The course information is presented in four modules using written text, videos, infographics, downloadable resources (including physical activity/exercise logbook and action plan templates) and learning activities. The course does not prescribe specific exercise. In total, the time required to complete all four modules and learning activities is approximately four hours (one hour per module).

The course was designed for this study. To monitor adherence, participants will be asked to self-report, at the 5-week timepoint, which course modules they have completed.
Intervention code [1] 324849 0
Lifestyle
Intervention code [2] 324850 0
Behaviour
Comparator / control treatment
Participants in the comparator group will receive access to a 3-page electronic pamphlet about OA and its management, currently available online from a reputable musculoskeletal consumer organisation, Musculoskeletal Australia. The pamphlet is anticipated to take 5-10 minutes to read in full.

After randomisation, participants will receive an email from the research team containing the pamphlet as a PDF attachment. Participants will be asked to read the pamphlet within the coming 5 weeks. At the 5-week timepoint, they will be asked to self-report if they read the pamphlet or not.

On completion of their involvement in the study (completed 13-week outcome measures), they will be provided with access to the experimental course (MOOC).
Control group
Active

Outcomes
Primary outcome [1] 333098 0
Knee/Hip Osteoarthritis Knowledge Scale
(KOAKS for people with knee osteoarthritis; HOAKS for people with hip osteoarthritis)
Timepoint [1] 333098 0
Baseline
5 weeks post randomisation (primary)
13 weeks post randomisation
Primary outcome [2] 333217 0
Pain subscale of the Arthritis Self-Efficacy Scale (ASES)
Timepoint [2] 333217 0
Baseline
5 weeks post randomisation (primary)
13 weeks post randomisation
Secondary outcome [1] 415780 0
Brief fear of movement for OA scale
Timepoint [1] 415780 0
Baseline
5 weeks post randomisation
13 weeks post randomisation
Secondary outcome [2] 415781 0
Self-efficacy for Exercise Scale
Timepoint [2] 415781 0
Baseline
5 weeks post randomisation
13 weeks post randomisation
Secondary outcome [3] 415782 0
Brief Illness Perceptions Questionnaire (B-IPQ)
Timepoint [3] 415782 0
Baseline
5 weeks post randomisation
13 weeks post randomisation
Secondary outcome [4] 415783 0
Treatment intentions (study-specific questionnaire)
Timepoint [4] 415783 0
5 weeks post randomisation
Secondary outcome [5] 415784 0
Intention to seek care from a health professional (study-specific questionnaire)
Timepoint [5] 415784 0
5 weeks post randomisation
Secondary outcome [6] 415785 0
Incidental and Planned Exercise Questionnaire, version W (IPEQ-W)
Timepoint [6] 415785 0
Baseline
13 weeks post randomisation
Secondary outcome [7] 415786 0
Current exercise/physical activity behaviour (study-specific questionnaire)
Timepoint [7] 415786 0
13 weeks post randomisation
Secondary outcome [8] 415787 0
Current weight loss behaviour (study-specific questionnaire)
Timepoint [8] 415787 0
13 weeks post randomisation
Secondary outcome [9] 415788 0
Current care seeking behaviour (study-specific questionnaire)
Timepoint [9] 415788 0
13 weeks post randomisation
Secondary outcome [10] 415789 0
Oral pain medication usage (study-specific questionnaire)
Timepoint [10] 415789 0
Baseline
13 weeks post randomisation

Eligibility
Key inclusion criteria
i. live in Australia;
ii. have an unreplaced (native) hip or knee joint that meets the National Institute for Health and Care Excellence clinical criteria for OA:
- aged 45 years or over;
- activity-related pain at the joint;
- joint morning stiffness that lasts less than or equal to 30 mins or no morning stiffness at the joint
iii. history of pain for at least 3 months at the joint; and
iv. joint pain on most days of the past month;
v. have access to a computer with internet connection and an email address; and
vi. able to give informed consent and willing to commit to all study evaluation and assessment procedures.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. self-reported systemic arthritis (e.g. rheumatoid arthritis, gout);
ii. scheduled for lower limb joint surgery in the next 13 weeks;
iii. completed an online educational course about OA that involved at least 2 hours of learning in total in the past 12 months; and/or
iv. unable to easily read and understand English.

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)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. The randomisation schedule will be concealed in a password protected computer database. A member of our research team will maintain and access the schedule and reveal allocation to the Trial Coordinator as each participant requires randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by an independent biostatistician. Randomisation of eligible participants to the control group or the experimental group will be conducted using randomly permuted blocks of varying sizes in a 1:1 ratio, stratified by eligible joint (hip/knee).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
2-arm, parallel-design, superiority, assessor- and participant- blinded randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
A sample size of 60 participants per arm (120 in total) is required for 90% power to demonstrate that the consumer-focused MOOC is superior to the control with a two-sided 2.5% significance level (accounting for Bonferroni correction for multiple comparisons, across the two primary outcomes) and accounting for a 20% dropout rate. This sample size is based on the following assumptions: a standardised between-group effect size of 0.625 for self-efficacy for pain (based on our prior educational research, corresponding to an absolute between-group difference in mean change from baseline to 5 weeks in ASES pain subscale score of 1 unit favouring the MOOC, within-group standard deviation (SD) of 1.6 units correlation between measures across all three timepoints of 0.5 (i.e., compound symmetry variance-covariance matrix) and using a constrained longitudinal data analysis (cLDA) model. With this sample size, we also have at least 90% power to detect a between-group effect size of 0.8 for OA knowledge (conservative for this type of program), corresponding to an absolute between-group difference in mean change from baseline to 5 weeks in KOAKS/HOAKS score of 4.6 units favouring the MOOC, within-group SD of 5.8 units, and correlation between measures across all three timepoints of 0.2.

Statistical Analysis Plan: A statistical analysis plan will be written by the biostatistician and published on our research centre’s website while blind to group allocation. The analysis will include participants according to their randomised allocation (intention-to-treat). Demographic and baseline characteristics of participants will be summarised as appropriate and will be inspected to assess baseline comparability of treatment groups. Each continuous outcome including the two primary outcomes measured at baseline and two follow-up timepoints will be analysed using a cLDA model. For continuous outcomes with one follow-up timepoint, differences in change will be compared between groups using linear regression models adjusted for baseline levels of these outcomes, where available. For binary outcomes, differences between groups will be compared using risk differences and risk ratios, obtained using log-binomial regression models, adjusted for the outcome at baseline where available. The proposed cLDA model provides valid inference in the presence of missing data if the data are missing at random. Should the amount of missing data for either primary outcome be greater than 5%, an analysis will be conducted using the delta-adjustment method under the pattern-mixture modelling framework in the context of multiple imputation to assess sensitivity to missingness not at random. All analysis models will be adjusted for the stratification factor, eligible joint (hip/knee).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2023
Actual
19/01/2023
Date of last participant enrolment
Anticipated
2/10/2023
Actual
7/07/2023
Date of last data collection
Anticipated
2/01/2024
Actual
6/10/2023
Sample size
Target
120
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312641 0
Government body
Name [1] 312641 0
National Health and Medical Research Council
Country [1] 312641 0
Australia
Funding source category [2] 312642 0
Charities/Societies/Foundations
Name [2] 312642 0
Physiotherapy Research Foundation
Country [2] 312642 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
161 Barry Street, Parkville,
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 314252 0
None
Name [1] 314252 0
Address [1] 314252 0
Country [1] 314252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311957 0
The University of Melbourne Science, Technology, Engineering, Mathematics and Medicine 3 Human Research Ethics Committee
Ethics committee address [1] 311957 0
Ethics committee country [1] 311957 0
Australia
Date submitted for ethics approval [1] 311957 0
01/08/2022
Approval date [1] 311957 0
21/09/2022
Ethics approval number [1] 311957 0
2022-24596-32828-3

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

Contacts
Principal investigator
Name 122962 0
Dr Rachel K Nelligan
Address 122962 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122962 0
Australia
Phone 122962 0
+61403652115
Fax 122962 0
Email 122962 0
Rachel.nelligan@unimelb.edu.au
Contact person for public queries
Name 122963 0
Rachel K Nelligan
Address 122963 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122963 0
Australia
Phone 122963 0
+61403652115
Fax 122963 0
Email 122963 0
Rachel.nelligan@unimelb.edu.au
Contact person for scientific queries
Name 122964 0
Rachel K Nelligan
Address 122964 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 122964 0
Australia
Phone 122964 0
+61403652115
Fax 122964 0
Email 122964 0
Rachel.nelligan@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
How or where can data be obtained?
By emailing the Principal Investigator at rachel.nelligan@unimelb.edu.au. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17607Study protocol  Rachel.nelligan@unimelb.edu.au
17608Statistical analysis plan  Rachel.nelligan@unimelb.edu.au
17609Informed consent form  Rachel.nelligan@unimelb.edu.au
17610Ethical approval  Rachel.nelligan@unimelb.edu.au
17611Analytic code  Rachel.nelligan@unimelb.edu.au
22197Data dictionary    The Data Dictionary will be supplied with the de-i... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a Massive Open Online Course on osteoarthritis knowledge and pain self-efficacy in people with hip and/or knee osteoarthritis: protocol for the MOOC-OA randomised controlled trial.2023https://dx.doi.org/10.1186/s12891-023-06467-x
N.B. These documents automatically identified may not have been verified by the study sponsor.