Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000188932
Ethics application status
Approved
Date submitted
3/12/2019
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Date results information initially provided
19/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Current management of patients with knee osteoarthritis in community physiotherapy practice: an observational study
Scientific title
Current management of patients with knee osteoarthritis in community physiotherapy practice: an observational study
Secondary ID [1] 297414 0
Nil known
Universal Trial Number (UTN)
U1111-1228-5999
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 311581 0
Condition category
Condition code
Musculoskeletal 310212 310212 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 313877 313877 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study that will examine current practice for the management of knee OA. Nine metropolitan-based, community physiotherapy practices and 30 patients with knee OA will be recruited. Patients will be included if they have activity-related joint pain, morning stiffness lasting <30 minutes and are aged over 45 years. All patients who who consent will have their physiotherapy notes audited using a proforma and participate in an interview with the researcher at 6 weeks taking approximately 30 minutes. Patients will also complete three patient reported outcome measures at baseline and 12 weeks taking up to 1 hr. All physiotherapists who consent will be interviewed by the researcher at 6 weeks after the final patient is recruited, each taking approximately 20 minutes.
Intervention code [1] 313663 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319097 0
Primary outcome 1 - Proportion of patients who are recorded as receiving care according to guidelines, as assessed by audit of patient treatment notes.
Timepoint [1] 319097 0
Timepoint. at 6 weeks post enrolment.
Primary outcome [2] 320498 0
Primary outcome 2 - Proportion of patients who have patient-reported outcomes incorporated into their assessment and management plan, as assessed by audit of patient treatment notes.
Timepoint [2] 320498 0
Timepoint. at 6 weeks post enrolment.
Secondary outcome [1] 366970 0
Secondary outcome 1 – knee stiffness, as assessed by patient reported outcome (Knee injury and Osteoarthritis Outcome Score)
Timepoint [1] 366970 0
Timepoint. Baseline and 12 weeks post enrolment.
Secondary outcome [2] 371817 0
Secondary outcome 2 – knee pain, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)
Timepoint [2] 371817 0
Timepoint. Baseline and 12 weeks post enrolment.
Secondary outcome [3] 377534 0
Secondary outcome 3 – knee function, as assessed by patient reported outcomes (Knee injury and Osteoarthritis Outcome Score and Multidimensional Health Assessment Questionnaire)
Timepoint [3] 377534 0
Timepoint. Baseline and 12 weeks post enrolment.
Secondary outcome [4] 377535 0
Secondary outcome 3 – Polysymptomatic distress, as assessed by patient reported outcomes (2011 Fibromyalgia criteria questionnaire)
Timepoint [4] 377535 0
Timepoint. Baseline and 12 weeks post enrolment.

Eligibility
Key inclusion criteria
People who present with knee OA defined as
• activity related joint pain
• morning stiffness<30 mins
• over 45 years old
These participants may also have
. bony enlargement
• crepitus on active motion
• deformity fixed flexion
• +/-varus/valgus
• knee instability
• peri-articular or joint tenderness
• pain on patellar femoral compression
• swelling

All physiotherapists working in the practices, who have given consent, will be included in the study.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded from participation if they have
• inflammatory arthritis
• rheumatoid arthritis
• gout
• history of/or current infection in the joint
• cognitive impairment
• significant trauma
• hemi or total knee replacement of affected joint
• have had knee surgery in the last 12 months
• or are being treated under workers compensation

Physiotherapists will be excluded from participation if they choose to opt out and do not consent, or withdraw consent at any time during the project.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
We are aiming for an opportunistic sample size of 30 participants, ideally achieving 3-4 patients per practice. Whilst 12 people typically provide sufficient information for theme saturation in qualitative studies, we aim to enrol participants from each clinic in order to get a mix of socioeconomic backgrounds. Further, the relatively large sample will provide evidence of a trend in efficacy (if there is one), that will inform sample size calculations for future studies.
We are aiming to recruit a minimum of 25 physiotherapists across nine community physiotherapy practices in the Sydney area.

Analysis
Audit of Treatment Notes
Data collected through the auditing of treatment notes will be recorded in Microsoft excel spreadsheets and analysed using descriptive statistics (mean, standard deviation, and proportion) as follows: The percent of patients who received each of the core guideline treatments and the percent of patients who were referred to another healthcare professional for each of the core guideline treatments.
Audited treatment notes will be compared against care that is recommended in guidelines for the conservative management of knee OA. However, descriptive statistics of the patient will determine if all core guideline treatments need to be address. For example, if the patient is obese, weight-management should be discussed, and a referral to a dietician made. But, if they had a BMI < 25, this treatment would be made null.

Primary outcomes of the study include identifying the proportion of patients who are recorded as receiving care according to guidelines, and proportion of patients who have patient-reported outcomes incorporated into their assessment and management plan.
Secondary outcomes of the study include changes in knee pain, knee stiffness, knee function, and polysymptomatic distress at 12 weeks compared to baseline as assessed by Patient Reported outcome Measures (PROMs).

Demographic and clinical characteristics will be collected through the use of PROMs at initial recruitment and 12 weeks. The baseline characteristics of the two cohorts will be presented to demonstrate comparability. The change in PROMS across time for each cohort will also be presented.
Patients experience and perspectives of how their knee OA was managed will be gathered using a semi-structured face to face interview at 6 weeks post recruitment.
Physiotherapists experience and perspectives of how they manage knee OA will be gathered using a semi -structured face to face interview 6 weeks after recruitment is completed.
Semi-structured interviews will be conducted, audio-recorded and transcribed. Data collected from interviews will be recorded in nVivo were it will be categorised and classified. This will reflect both the patients and physiotherapists experiences and perceptions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/03/2019
Date of last participant enrolment
Anticipated
Actual
7/08/2019
Date of last data collection
Anticipated
Actual
8/01/2020
Sample size
Target
55
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25699 0
2000 - Haymarket
Recruitment postcode(s) [2] 25700 0
2560 - Campbelltown
Recruitment postcode(s) [3] 25701 0
2068 - Willoughby
Recruitment postcode(s) [4] 25702 0
2063 - Northbridge
Recruitment postcode(s) [5] 25703 0
2170 - Mount Pritchard
Recruitment postcode(s) [6] 25704 0
2170 - Liverpool
Recruitment postcode(s) [7] 25705 0
2154 - Castle Hill
Recruitment postcode(s) [8] 25706 0
2000 - Sydney
Recruitment postcode(s) [9] 25707 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 301981 0
Other Collaborative groups
Name [1] 301981 0
Sydney Translational Research and Education Alliance for Musculoskeletal (STREAM) Health
Country [1] 301981 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 301766 0
Other
Name [1] 301766 0
Neuroscience Research Australia (NeuRA)
Address [1] 301766 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street
Randwick, Sydney,
NSW 2031
Country [1] 301766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302660 0
The University of New South Wales Human Research Ethics Advisory Panel D
Ethics committee address [1] 302660 0
High St
Kensington, NSW 2052
Ethics committee country [1] 302660 0
Australia
Date submitted for ethics approval [1] 302660 0
05/11/2018
Approval date [1] 302660 0
05/02/2019
Ethics approval number [1] 302660 0
HC180864

Summary
Brief summary
Historically, the management of knee OA has been variable, and often limited to pharmaceutical management and total joint replacement. Recently, evidence-based recommendations for the management of knee OA have been developed by scientific societies and health organisations. Best-practice guidelines for the treatment of knee OA focus on conservative (non-operative) multidisciplinary management that encompasses education, exercise, lifestyle modification and weight-loss where relevant, while promoting self-management. This body of evidence demonstrates that multidisciplinary conservative management of knee OA is efficacious. This observational study aims to discover how knee osteoarthritis patients are currently been managed by community physiotherapists, and if this aligns with recommended guidelines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90970 0
Mrs Rebecca Livings
Address 90970 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 90970 0
Australia
Phone 90970 0
+61 0428071588
Fax 90970 0
Email 90970 0
[email protected]
Contact person for public queries
Name 90971 0
Mrs Rebecca Livings
Address 90971 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 90971 0
Australia
Phone 90971 0
+61 0428071588
Fax 90971 0
Email 90971 0
[email protected]
Contact person for scientific queries
Name 90972 0
Mrs Rebecca Livings
Address 90972 0
Neuroscience Research Australia
Margarete Ainsworth Building
Baker Street, Randwick, Sydney, NSW 2031
Country 90972 0
Australia
Phone 90972 0
+61 0428071588
Fax 90972 0
Email 90972 0
[email protected]

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 data collected during the study, after de-identification
When will data be available (start and end dates)?
Beginning 3 months following main results publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6734Study protocol  [email protected]
6735Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementation of a community-based, physiotherapy-led, multidisciplinary model of care for the management of knee osteoarthritis: Protocol for a feasibility study.2020https://dx.doi.org/10.1136/bmjopen-2020-039152
N.B. These documents automatically identified may not have been verified by the study sponsor.