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Trial registered on ANZCTR


Registration number
ACTRN12621000910808p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2021
Date registered
14/07/2021
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an infographic increase knowledge of physical activity after knee joint replacement?
Scientific title
Does a consumer co-designed infographic increase knowledge of physical activity after elective total knee joint replacement? A randomised controlled trial
Secondary ID [1] 304415 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge of physical activity after elective total knee joint replacement 322218 0
Self efficacy for exercise after elective total knee joint replacement 322219 0
Health literacy 322579 0
Condition category
Condition code
Public Health 319913 319913 0 0
Health promotion/education
Musculoskeletal 320191 320191 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Co-designed infographic 6 weeks to 6 months after total knee replacement
Intervention aim: Increase knowledge of physical activity and self-efficacy for exercise
Materials used: Co-designed infographic that provides health information specific to increasing knowledge of key physical activity constructs
Procedures: The infographic will be designed with the aid of consumers and will consist of two stages. Stage 1 - Consumers co-design a draft infographic. 5-10 consumers will be recruited in the stage 1 co-design phase. Consumers will meet with the researcher for a single 1 hour workshop to provide their ideas on the layout and design (e.g. graphics, the layout, the wording, which aspects of physical activity to emphasise) of an infographic. Participants will be given the choice as to whether they meet the researcher via a video link (e.g. Zoom) or in person at a location of their choice. Participants who choose to meet with the researcher via video link may meet with the researcher and 2-3 other participants or individually - this depends on the times that participants are available to participate in the video link workshop. Participants who prefer to meet face to face with the researcher will do so individually. 5-10 participants will initially provide their perspective on the layout and design of an infographic that provides physical activity information to people after total knee replacement. The final numbers of participants who are involved in the initial co-design phase will ultimately be determined by data saturation i.e. no new ideas about infographic design are being presented by the participants. When meeting with the consumers, the researcher will present infographics on other topics as examples to help guide the participants. The researcher will then collate the infographic design ideas from the participants and, with the aid of a graphic designer, produce a draft infographic. Stage 2 - Consumers provide feedback on draft infographic. The draft infographic will then be shown to 5 more participants who will be invited to provide feedback on the layout, design and content of the draft infographic. Consumers will again be given the option to meet with the researcher via video link or face to face. The feedback session will be conducted once with each consumer and last for an hour. The researcher will again collate the feedback on the draft infographic and, with the aid of a graphic designer, produce the final infographic. The final version of the infographic will then be used in the randomised controlled trial. During both phases of infographic design, co-design principles will be used to maximise the ability of the infographic to resonate with people after knee joint replacement and increase their knowledge of physical activity.
Randomised controlled trial phase. The infographic intervention will be provided to participants 6 weeks to 6 months after their knee joint replacement surgery. The infographic is likely to provide information on the following aspects of physical activity: how much physical activity the World Health Organisation recommends for health, the type of physical activity that benefits health, how to distinguish between low and moderate-intensity physical activity, examples of the different types of physical activities that people could engage in after recovering from knee joint replacement e.g. brisk walking or hydrotherapy. The intervention will be applied once only.
Who provides intervention: Consumers who have had a total knee replacement will co-design the intervention (infographic). Researcher (background of physiotherapist) to provide infographic to participants
How intervention provided: Infographic either emailed or mailed to participants (participants preference). The study researcher will contact each participant in the intervention arm by phone or email to confirm that they have received the infographic.
Intervention code [1] 320773 0
Treatment: Other
Comparator / control treatment
Control group will not receive the co-designed infographic until after the 6-week study period and they have completed their involvement in the study.
Control group
Active

Outcomes
Primary outcome [1] 327785 0
Knowledge of physical activity questionnaire. This questionnaire is a section (Part 1) of a validated physical activity questionnaire conducted by Deans et al, 2020 (reference below). The sections of the original questionnaire that we are not using have to do with how clinicians view physical activity and are not relevant to our study.

(Deans S, Kirk A, McGarry A, Rowe D. Physical activity guidelines and promotion: an online survey of United Kingdom’s prosthetic rehabilitation healthcare professionals. Prosthet Orthot Int 2020;44:192-201.).

Timepoint [1] 327785 0
The questionnaire will be administered at three time points:
Baseline (week 0)
One week after study commencement
Six weeks after study commencement
Secondary outcome [1] 396594 0
Self-efficacy for Exercise (SEE) Scale - a validated scale. We have modified the language of the scale slightly to ensure it reflects the updated physical activity guidelines published by the World Health Organisation in 2020.
Timepoint [1] 396594 0
The Self-efficacy for Exercise Scale will be administered at three time points:
At baseline (week 0)
One week after study commencement
Six weeks after study commencement
Secondary outcome [2] 396596 0
Semi-structured interviews will be conducted with the intervention arm (people who received the infographic) evaluating the infographic's acceptability.

The semi-structured interviews will be conducted one-on-one using a questionnaire as a guide, however the researcher may ask follow up questions to explore further lines of enquiry. Questions will be open-ended. The interview will take 10-15 minutes to conduct and participants will be given the option to take part in the interview over a video link, over the phone or face-to-face The interview will be audiotaped, transcribed and analysed for themes. An example of a question to determine infographic acceptability is: what did you think about the infographic? An example of a follow up question is: how easy to understand was the information in the infographic?
Timepoint [2] 396596 0
Six weeks after study commencement (intervention arm only)
Secondary outcome [3] 397444 0
During the semi-structured interview, the implementation of the infographic will also be evaluated. An example of a question to determine infographic implementation is: how did you use the infographic? Examples of follow-up questions are: where did you put the infographic? how often did you look at the infographic?
Timepoint [3] 397444 0
Six weeks after study commencement (intervention arm only)
Secondary outcome [4] 397445 0
During the semi-structured interview, the limited efficacy of the infographic will also be evaluated. An example of a question to determine infographic limited efficacy is: how did the infographic change the way you felt about physical activity? An example of a follow-up question is: tell me about anything different you are doing as a result of the infographic?
Timepoint [4] 397445 0
Six weeks after study commencement (intervention arm only)

Eligibility
Key inclusion criteria
Adults who have undergone elective primary total knee joint replacement surgery secondary to osteoarthritis 3-12 months previously will be eligible to participate in the co-design of the infographic.

Adults who have undergone elective primary total knee joint replacement surgery secondary to osteoarthritis 6 weeks to 6 months previously will be eligible to participate in the randomised controlled trial to evaluate the effectiveness of the co-designed infographic in increasing knowledge of physical activity and self-efficacy for exercise.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded from the infographic co-design process and randomised controlled trial if their knee surgery is not a primary total joint replacement (e.g. revision of joint replacement, hemiarthroplasty) or not secondary to osteoarthritis (e.g. rheumatoid arthritis or trauma), if the person has significant cognitive issues (e.g. has a reported medical history of dementia), has hearing loss that would affect communication or is not confident communicating in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation process will be prepared and coordinated by an independent, off-site person. A computer-generated randomisation sequence will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block randomisation will be used to allocate participants 1:1 to the experimental (receive the infographic) or control (will not receive the infographic) groups, with stratification based on health service funding (i.e. private vs public patients). A block size of four will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Infographic Co-design phase - Sample size and statistical analysis
The infographic co-design phase consists of two sections: a) designing and producing a draft infographic, b) analysing, interpreting and providing feedback on the draft infographic prior to the production of the final infographic. The sample size of both infographic co-design sections will be informed by a recent study that investigated the effectiveness of an infographic to increase knowledge of physical activity in women with gestational diabetes mellitus (Harrison et al, 2020). Consequently, it is anticipated 5-10 participants will be recruited to participate in co-designing the draft infographic, and 5 participants will be recruited to provide feedback on the draft infographic prior to the production of the final infographic. However, the final numbers of consumers involved in both sections of the infographic co-design phase will be guided by the concept of having achieved consensus (when no new ideas about infographic design are being generated). In line with co-design protocol, participant sampling for both infographic co-design sections will be purposive and endeavour to represent genders, ages, ethnic backgrounds and physical activity levels

Consumer data recorded from the infographic co-design phase (Stage 1: creation of the draft infographic; Stage 2: feedback provided about draft infographic) will be analysed for content. Attention will be paid to how consumers feel the infographic should be designed (e.g. type of graphics, font sizes and colours used, layout of the infographic), which physical activity messages should be included in the infographic and how these messages are worded.

Randomised Controlled Trial phase - Sample size and statistical analysis
Based on the effect observed in another trial reporting increased knowledge of physical activity after provision of a co-designed infographic (d=0.92) (Harrison et al, 2020), a sample of n=40 will provide power of 0.80 at an alpha level of 0.05. Assuming attrition of 10% a total sample of n=44 (22 allocated to each group) will be recruited with equal allocation into the experimental and control groups

The difference in mean values of knowledge and self-efficacy between intervention and control groups will be analysed using linear mixed models. Data will be analysed using SPSS.

The intention-to-treat principle will be used when analysing study data with all available data used regardless of compliance. Data analysis will take place without ad hoc imputation of missing data (e.g. last observation carried forward or best value replacement).

Interpretation of the trial results will be informed by the design and aims of the study. This study is a pilot study designed to estimate the effect of the intervention. As such, interpretation of results will take into consideration the sample size and the large effect size used in the sample size calculation. Typically, the effect size used to calculate the trial sample size is considered the smallest worthwhile effect of the intervention, and an intervention may not be considered significant if the mean difference 95%CI does not exceed the smallest worthwhile effect. However, in this pilot study, if a large effect size (in this instance, d=0.93) was used to define the smallest worthwhile effect, estimates of effect of the intervention may not be detected, especially if, as is anticipated, the mean difference 95%CI does not exceed 0.93. As such, the principle of 0.5 of a standard deviation (Norman et al, 2003) will be used to guide the interpretation of the clinical significance of the results, with half the standard deviation of the control group’s knowledge of physical activity score at baseline nominated as the smallest worthwhile effect. The possibility that the trial is underpowered to detect a smallest worthwhile effect that is less than 0.93 will be noted in the limitations section of the study difference.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19651 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 19652 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 34284 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 308782 0
University
Name [1] 308782 0
La Trobe University
Address [1] 308782 0
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country [1] 308782 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
NHMRC Centre for Research Excellence in Total Joint Replacement
The University of Melbourne Department of Surgery, St Vincent's Hospital
Level 2 Clinical Sciences Building
29 Regent Street
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 309691 0
None
Name [1] 309691 0
Address [1] 309691 0
Country [1] 309691 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308695 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 308695 0
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 308695 0
Australia
Date submitted for ethics approval [1] 308695 0
31/05/2021
Approval date [1] 308695 0
Ethics approval number [1] 308695 0

Summary
Brief summary
This study comprises two sections.
o Section 1: Co-design section: The aim of this section is to co-design an infographic with the assistance of consumers (in this instance, people who have had a knee replacement). The aim of the infographic is to increase people’s knowledge of physical activity after knee joint replacement surgery.
o Section 2: Randomised controlled trial: The aim of this section is to measure how effective the infographic is at increasing people’s knowledge of physical activity after total knee joint replacement with a randomised controlled trial. Outcome measures will be based on previously published questionnaires that evaluate knowledge of physical activity, self-efficacy for exercise and the participant's engagement with the infographic. Measures will take place at baseline, 1 and 6 week after study commencement.
Participants for both sections will be recruited from the SMART registry (HREC A 100/14) of total joint replacement surgery maintained by St Vincent’s Hospital, Melbourne, including public and private patients. It is anticipated that 10-15 participants will take part in co-designing the infographic, and 44 participants will take part in the randomised controlled trial.

Study hypothesis: We expect that people who receive the co-designed infographic will demonstrate an increase in knowledge of physical activity and an increase in self-efficacy for exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111586 0
Prof Nicholas Taylor
Address 111586 0
Eastern Health Allied Health Clinical Research Office
Level 2
5 Arnold Street
Box Hill VIC 3128
Country 111586 0
Australia
Phone 111586 0
+61 3 90918874
Fax 111586 0
Email 111586 0
n.taylor@latrobe.edu.au
Contact person for public queries
Name 111587 0
Mr Lyndon Hawke
Address 111587 0
Eastern Health Allied Health Clinical Research Office
Level 2
5 Arnold Street
Box Hill VIC 3128
Country 111587 0
Australia
Phone 111587 0
+61 0420577049
Fax 111587 0
Email 111587 0
l.hawke@latrobe.edu.au
Contact person for scientific queries
Name 111588 0
Mr Lyndon Hawke
Address 111588 0
Eastern Health Allied Health Clinical Research Office
Level 2
5 Arnold Street
Box Hill VIC 3128
Country 111588 0
Australia
Phone 111588 0
+61 0420577049
Fax 111588 0
Email 111588 0
l.hawke@latrobe.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 other documents available
Summary results
No Results