Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001230145
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
5/09/2019
Date last updated
5/09/2019
Date data sharing statement initially provided
5/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of an expert-moderated peer-to-peer online support group versus an information website alone for people with knee osteoarthritis: A feasibility study and pilot randomised controlled trial
Scientific title
Effectiveness of an expert-moderated peer-to-peer online support group versus an information website alone for people with knee osteoarthritis: A feasibility study and pilot randomised controlled trial
Secondary ID [1] 298719 0
Nil known
Universal Trial Number (UTN)
U1111-1236-8858
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 313630 0
Condition category
Condition code
Musculoskeletal 312060 312060 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Participants in this group will be provided access to a bespoke expert-moderated, peer-to-peer online support group (OSG), in addition to being given details of the My Joint Pain website.

The OSG will focus on providing peer-to-peer support through discussion forums. It will also provide evidence-based information posts and advice from ‘expert’ health professional(s) who have been trained, are culturally sensitive and who support a belief in the ability of people with knee OA to learn self-management skills. The ‘expert’ will also moderate posts and remove inappropriate posts (such as product advertising) or posts with offensive tone or language. The 'expert moderator' will be a pool of people. Anyone who carries out the 'expert moderator' tasks will have expertise in knee OA management and the written communication skills required for role. They will all be staff members of the Centre for Health Exercise and Sports Medicine. Where specific expertise from a physiotherapist is required, a moderator with a physiotherapy background will provide the response.
Participants may engage with the OSG as much or as little as they like but will be requested to log in at least once.
Quantity and quality of engagement with the OSG and website will be assessed using a combination of analytics (i.e. time spent on the forum, number of posts during first 3 months, number of posts during second 3 months), survey and qualitative interviews.

The My Joint Pain website is a freely available information website developed and maintained by Arthritis Australia: https://www.myjointpain.org.au/ . This website has been developed for Australian users and provides up to date information about OA management including general information and services available, a risk assessment tool, and a management planning tool.
Intervention code [1] 314979 0
Behaviour
Comparator / control treatment
Control group: Participants in this group will be given the details of the My Joint Pain website.
Control participants may engage with the website as much or as little as they like but will be requested to look at the website at least once.
Quantity and quality of engagement with the website will be assessed using surveys.
Control group
Active

Outcomes
Primary outcome [1] 321220 0
1. Implementation fidelity - measured by software analytics (time spent on the forum, number of posts during first 3 months)
Timepoint [1] 321220 0
3 months
Primary outcome [2] 321221 0
2. Satisfaction with the intervneiton - measured by a visual analogue scale
Timepoint [2] 321221 0
3 months
Primary outcome [3] 321222 0
3. Costs - measured by calculating the number and type of posts by the moderator
Timepoint [3] 321222 0
3 months
Secondary outcome [1] 373973 0
1. Motivation (intention) for core behaviours - Numeric rating scales (NRS) (0-10) for intention and importance: a) Please rate how important it is for you to be more active / lose weight, b) How much do you agree with the following statement? I intend to increase my activity / lose weight? c) How motivated are you to be more active / lose weight?
Timepoint [1] 373973 0
3 and 6 months post randomisation
Secondary outcome [2] 374354 0
2. Self-efficacy - Arthritis Self-Efficacy Scale (ASES): 'Self-efficacy for Control of Pain' and 'Other Arthritis Symptoms' subscales
Timepoint [2] 374354 0
3 and 6 months post randomisation.
Secondary outcome [3] 374355 0
3. Impact of health education - Health Education Impact Scale (heiQ)
Timepoint [3] 374355 0
3 and 6 months post randomisation.
Secondary outcome [4] 374356 0
4. Health literacy - Health Literacy Questionnaire (HLQ)
Timepoint [4] 374356 0
3 and 6 months post randomisation.
Secondary outcome [5] 374357 0
5. Attitudes toward self-management - Patient Activation Measure (PAM-13)
Timepoint [5] 374357 0
3 and 6 months post randomisation.
Secondary outcome [6] 374358 0
6. Coping - Brief Coping Strategy Questionnaire (CSQ)
Timepoint [6] 374358 0
3 and 6 months post randomisation.
Secondary outcome [7] 374359 0
7. Social support - Duke-UNC Functional Social Support Questionnaire (FSSQ)
Timepoint [7] 374359 0
3 and 6 months post randomisation.
Secondary outcome [8] 374360 0
8. Fear of movement (kinesiophobia) - Brief Fear of Movement Scale for Osteoarthritis
Timepoint [8] 374360 0
3 and 6 months post randomisation.
Secondary outcome [9] 374361 0
9. Exercise behavoiur - Single item question (NRS 0-7): “How many days in the past week did you do leg strengthening exercises?”
Timepoint [9] 374361 0
3 and 6 months post randomisation.
Secondary outcome [10] 374362 0
10. Physical activity - Incidental and Planned Exercise Questionnaire (past week) (IPEQ-WA)
Timepoint [10] 374362 0
3 and 6 months post randomisation.
Secondary outcome [11] 374363 0
11. Physical activity - Single item quetion (NRS 0-7) “How many days in the past week did you do 30 minutes of moderate intensity physical activity? Moderate intensity means being activity at a level that makes you feel at least a little out of breathe or feels “somewhat hard” or harder.”
Timepoint [11] 374363 0
3 and 6 months post randomisation.
Secondary outcome [12] 374364 0
12. Other self-management behaviours - Single item quetion (NRS 1-4) “I have a personal plan to manage arthritis".
Timepoint [12] 374364 0
3 and 6 months post randomisation.
Secondary outcome [13] 374365 0
13. Health services/professionals visited for knee pain - “In the past 3 months, have you seen or attended any of the following because of your knee pain?”
Timepoint [13] 374365 0
3 and 6 months post randomisation.
Secondary outcome [14] 374366 0
14. Health-related quality of life - Assessment of Quality of Life Instrument (AQoL-6D)
Timepoint [14] 374366 0
3 and 6 months post randomisation.
Secondary outcome [15] 374367 0
15. Overall average knee pain - Self-reported on NRS (0-10) “Please rate your overall average knee pain in the last week where 0=“No pain” and 10=“Worst pain possible”
Timepoint [15] 374367 0
3 and 6 months post randomisation.
Secondary outcome [16] 374368 0
16. Activity-related pain - Self-reported on NRS (0-10) “During the past week, what was the worst pain you felt during an activity that usually brings on your knee pain on a scale from 0 to 10, where 0 is no pain and 10 is your worst pain imaginable?”
Timepoint [16] 374368 0
3 and 6 months post randomisation.
Secondary outcome [17] 374369 0
17. Physical function - Western Ontario & McMaster University Osteoarthritis Index Physical Function subscale (WOMAC-PF)
Timepoint [17] 374369 0
3 and 6 months post randomisation.
Secondary outcome [18] 374370 0
18. Mood (depressive symptoms) - Patient Health Questionnaire (9 item) (PHQ-9)
Timepoint [18] 374370 0
3 and 6 months post randomisation.
Secondary outcome [19] 374371 0
19. Fatigue - Self-reported single item NRS (0-10) “How fatigued do you currently feel?”
Timepoint [19] 374371 0
3 and 6 months post randomisation.
Secondary outcome [20] 374372 0
20. Sleep - Self-reported single item NRS (0-10) “In the past 7 days, how would you rate your sleep quality overall?”
Timepoint [20] 374372 0
3 and 6 months post randomisation.
Secondary outcome [21] 374373 0
21. Global rating of change - Overall change in knee condition since commencing in the study (7-point NRS)
Timepoint [21] 374373 0
3 months post randomisation.

Eligibility
Key inclusion criteria
Participants may be eligible for the study if they meet all inclusion criteria below:

Inclusion criteria

i) Aged greater or equal to 45 years;
ii) Clinical diagnosis of knee OA:
a) Activity-related knee pain
b) No morning joint-related stiffness, or morning stiffness that lasts no longer than 30 minutes
iii) Report knee pain on most days of the past month;
iv) Experienced knee pain for 3 months or more;
v) Have access to and uses, or is willing to use the internet at least once a week
vi) Prepared to engage in OSG if randomised to that group
vii) Able to give informed consent regarding willingness to be randomised and to participate fully in the assessment procedures.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

i) Previous knee replacement on affected knee, or on the waiting list for knee surgery
ii) Unable to speak English or unable to read English;
iii) Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis;
iv) Currently participating in an arthritis support group;
v) Other serious medical condition or upcoming medical procedures that in the opinion of the research staff and/or investigators would preclude participation;

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)
To conceal allocation, the randomisation schedule will be accessed via a password-protected, computer program by a researcher not involved in participant recruitment scheduling or assessment. 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer generated in advance according to a 2:1 ratio, using random permuted blocks of varying sizes (4-10) by a person not involved in recruitment of participants (JK, biostatistician).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis plan

Outcome measures:
Psychological determinants and health outcomes will be reported descriptively by treatment group assignment.

Sample size estimation for full RCT:
For this question we look at the upper bound of the 95% confidence interval for the SD for our chosen main trial primary outcome measures.

Budget estimation for full RCT:
Here we look at the hours of work required by the moderator for moderating the OSG once it has momentum, and the costs of recruitment for the 60 pilot study participants.

Feasibility:
Here will consider the following:
- Quantity and quality of engagement from analytics and qualitative study
- Satisfaction with OSG from survey question and qualitative study
- Recruitment and retention feasibility
- Fidelity to study protocol – missing data

Data pertaining to these feasibility questions will be obtained from the questionnaire responses and reported descriptively, plus supplemented by findings from the qualitative analyses.

Qualitative analysis plan

For both qualitative studies, in addition to summarising the content into broad categories e.g. type of social support, thematic analyses of the data will be conducted following procedures described by Braun & Clark [1].

1. Braun V, Clarke V: Using thematic analysis in psychology. Qualitative research in psychology 2006, 3(2):77-101.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/09/2019
Actual
Date of last participant enrolment
Anticipated
10/10/2019
Actual
Date of last data collection
Anticipated
10/03/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303272 0
Government body
Name [1] 303272 0
National Health & Medical Research Council
Country [1] 303272 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 303661 0
None
Name [1] 303661 0
Address [1] 303661 0
Country [1] 303661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303810 0
Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 303810 0
The University of Melbourne
Parkville
Victoria 3010
Ethics committee country [1] 303810 0
Australia
Date submitted for ethics approval [1] 303810 0
17/06/2019
Approval date [1] 303810 0
05/07/2019
Ethics approval number [1] 303810 0
1853275.2

Summary
Brief summary
The overall project aim is to investigate the effectiveness of adding an expert-moderated, peer-to-peer online support group (OSG) to an information website for people with clinically diagnosed knee osteoarthritis (OA). This study will investigate the feasibility of conducting the RCT by exploring fidelity (to trial and intervention protocols), satisfaction and engagement with the planned interventions, outcomes and costs. The primary objective will be to determine the feasibility of delivering the intervention in a trial setting and of recruiting and retaining participants. In terms of outcome measures, we will explore the impact of the intervention on psychological determinants that can explain self-management and lifestyle behaviour change. We will also measure behaviour and health outcomes as part of the feasibility assessment. The study will include two nested qualitative studies that will explore the type and content of posts, and the perceptions and experiences of participants in the OSG.
We will conduct a two-arm, pragmatic parallel-design randomised controlled pilot trial (RCT) in 60 volunteers (20 in control group, 40 in intervention group) from around Australia who have clinical knee OA. The study will be run from the Centre for Health, Exercise and Sports Medicine at the University of Melbourne.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94890 0
Dr Thorlene Egerton
Address 94890 0
Department of Physiotherapy | Centre for Health Exercise & Sports Medicine
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 94890 0
Australia
Phone 94890 0
+61 03 8344 1233
Fax 94890 0
Email 94890 0
[email protected]
Contact person for public queries
Name 94891 0
Dr Thorlene Egerton
Address 94891 0
Department of Physiotherapy | Centre for Health Exercise & Sports Medicine
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 94891 0
Australia
Phone 94891 0
+61 03 8344 1233
Fax 94891 0
Email 94891 0
[email protected]
Contact person for scientific queries
Name 94892 0
Dr Thorlene Egerton
Address 94892 0
Department of Physiotherapy | Centre for Health Exercise & Sports Medicine
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 94892 0
Australia
Phone 94892 0
+61 03 8344 1233
Fax 94892 0
Email 94892 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
Due to the very small number of participants and the semi-public nature of the forum posts for those allocated to the intervention group in this pilot study it will be difficult to ensure anonymity of the participants.


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.