ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000622505

Ethics application status

Approved

Date submitted

26/04/2024

Date registered

14/05/2024

Date last updated

14/07/2024

Date data sharing statement initially provided

14/05/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The influence of a knee osteoarthritis diagnosis on people’s beliefs about the condition

Scientific title

Effects of a radiographic diagnosis and explanation of knee osteoarthritis on consumer beliefs about knee pain management: an online randomised controlled trial in adults aged 45 and over who have and have not experienced activity-related knee joint pain

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The entire trial will be administered in one single online survey.

Eligible participants will be asked to imagine a hypothetical scenario where they have made an appointment with a General Practitioner (GP) to find out what is wrong with their painful knee. Participants will then be automatically randomised into one of three groups, all of which will be asked to watch a pre-recorded video on their screen where they receive a hypothetical knee osteoarthritis (OA) diagnosis from their GP.

The three groups will be:

i) Clinical diagnosis and explanation without being sent for x-ray: the video will show the GP providing a clinical diagnosis of knee OA based on their age and symptoms, including an explanation of why x-rays are not necessary for OA diagnosis. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

ii) Diagnosis and explanation based on x-ray findings (but without showing the x-ray images): the video will show the GP ordering an x-ray for the participant, summarising the x-ray report (but not showing the participant the x-ray images), and providing a diagnosis of knee OA. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

iii) Diagnosis and explanation based on x-ray (and showing the x-ray images): the video will show the GP ordering an x-ray for the participant, then summarising the x-ray report and Showing them the x-ray images, and providing a diagnosis of knee OA. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

The video for all groups will be scripted in a way that intends to reflect what typical language and communication style may look like in a real-world general practice setting. The video in each group is anticipated to last for 2-3 minutes.

With regards to fidelity, we will collect data on whether watched allocated video or not
time spent watching video.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

This is a three arm study, with the three groups described above. The reference comparator will be group 3, which will receive a diagnosis based on xray and will be shown the images.

Control group

Active

Outcomes

Primary outcome [1]

Belief about joint replacement surgery

Timepoint [1]