Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000710527
Ethics application status
Approved
Date submitted
20/05/2024
Date registered
6/06/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
6/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of building self-efficacy on outcomes of total knee replacement surgery (TKR)
Scientific title
Evaluating the effectiveness of a brief self-efficacy intervention to improve outcomes in patients recovering from a Total Knee Replacement (TKR)
Secondary ID [1] 312165 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 333817 0
Condition category
Condition code
Musculoskeletal 330486 330486 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 330487 330487 0 0
Physiotherapy
Mental Health 330611 330611 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates a brief self-efficacy guided reminiscence intervention conducted over the phone. This intervention will involve a 5-minute conversation where a researcher prompts participants to recall a time in their life they have overcome a challenge, and think about the strength they demonstrated during this time before and whilst doing their prescribed physiotherapy knee exercises at home. The participant will not share their challenging experience with the researcher, they will simply personally recall it. This intervention is developed in consultation with clinicians and patients who have undergone TKR surgery, and is designed to elicit self-efficacy through past memory of mastery experiences.

Participants will receive the intervention once in an individual phone call, between their two physio appointments in either week 3 (Group A: intervention arm) or week 4 (Group B: waitlist control arm) after total knee replacement (TKR) surgery.

Adherence to the intervention will be assessed in a feedback survey designed for the purposes of the study, sent to participants at the end of the two-week period. This survey will ask participants if they thought about the hard experience they overcame before or during their exercises. If the answer is yes, they will be asked to state how often, and if no, they will be asked to describe the reasons why they did not.
Intervention code [1] 328609 0
Behaviour
Intervention code [2] 328628 0
Treatment: Other
Comparator / control treatment
All participants will receive the intervention, but at different times according to their randomly allocated group. In week 3 post-surgery, Group A will receive usual care as well as the intervention, whilst Group B will serve as a waitlist control, and receive usual care only. In week 4 post-surgery, Group A who have already received the intervention will receive usual care, whilst Group B will receive usual care and the intervention. Usual care is defined as individually-tailored face to face physical therapy for rehabilitation from TKR surgery at an outpatient clinic.
Control group
Active

Outcomes
Primary outcome [1] 338256 0
Perceived self-efficacy to complete exercises despite pain
Timepoint [1] 338256 0
The first and second appointment of week 3 post-surgery, the first and second appointment of week 4 post-surgery.
Secondary outcome [1] 435172 0
Exercise adherence
Timepoint [1] 435172 0
Daily, throughout week 3 and 4 post-surgery
Secondary outcome [2] 435173 0
Perceived self-efficacy to participate in daily living activities despite pain
Timepoint [2] 435173 0
The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.
Secondary outcome [3] 435175 0
Pain intensity
Timepoint [3] 435175 0
3 times in each appointment: beginning of appointment (overall pain last 24 hours), beginning of appointment (pain whilst doing exercises at home last 24 hours), after doing a session of exercises with the physiotherapist. Measured in the first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.

Pain intensity recorded by participant daily in exercise diary.
Secondary outcome [4] 435176 0
Knee range of motion (active and passive)
Timepoint [4] 435176 0
The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.
Secondary outcome [5] 435177 0
Medication use
Timepoint [5] 435177 0
The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.
Secondary outcome [6] 435178 0
Patient feedback on the intervention
Timepoint [6] 435178 0
The evening after their second physio appointment in week 4

Eligibility
Key inclusion criteria
Able to read and understand the consent form autonomously
Undergone total knee replacement in the past two weeks
Attending Epworth outpatient physiotherapy clinic for post-surgery rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Randomised by computer software (Qualtrics)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software (Qualtrics)
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
A one-way between-subjects analysis of variance (ANOVA) will be conducted with the group (intervention or waitlist control) as the independent variable and the change scores from the first appointment to the second appointment in week 3 post-surgery on perceived self-efficacy to complete exercises despite pain, perceived self-efficacy to participate in daily living activities, pain intensity and range of motion as the dependent variables. Only participants who have received the intervention in week 3 post-surgery (Group A) will be included as the ‘intervention group’.

A between-subjects analysis of covariance (ANCOVA) will be conducted with intervention/waitlist control as the independent variable, adherence to exercise as the dependent variable and opioid medication use as the covariate.

If we do not meet our sample size requirements, a one-sided t-test with an 80% confidence interval will be used to determine the effect of the intervention on these outcomes, as a traditional significance test is not expected to reveal significance.

Analyses will be conducted using SPSS software (version 29). Additionally, patient feedback will be transcribed verbatim and analysed descriptively by two independent coders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
11/06/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
72
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26551 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment postcode(s) [1] 42591 0
3216 - Waurn Ponds

Funding & Sponsors
Funding source category [1] 316530 0
University
Name [1] 316530 0
University of Sydney
Country [1] 316530 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318719 0
None
Name [1] 318719 0
Address [1] 318719 0
Country [1] 318719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315323 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315323 0
Ethics committee country [1] 315323 0
Australia
Date submitted for ethics approval [1] 315323 0
29/04/2024
Approval date [1] 315323 0
23/05/2024
Ethics approval number [1] 315323 0
2024/ETH00887

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

Contacts
Principal investigator
Name 134338 0
A/Prof Claire Ashton-James
Address 134338 0
Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 134338 0
Australia
Phone 134338 0
+61 410 365 816
Fax 134338 0
Email 134338 0
[email protected]
Contact person for public queries
Name 134339 0
Claire Ashton-James
Address 134339 0
Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 134339 0
Australia
Phone 134339 0
+61 410 365 816
Fax 134339 0
Email 134339 0
[email protected]
Contact person for scientific queries
Name 134340 0
Claire Ashton-James
Address 134340 0
Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 134340 0
Australia
Phone 134340 0
+61 410 365 816
Fax 134340 0
Email 134340 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?
De-identified outcome data
When will data be available (start and end dates)?
Upon publication of the data, no end date
Available to whom?
Anyone upon reasonable request to the primary investigator
Available for what types of analyses?
For meta-analyses and sub-analyses
How or where can data be obtained?
Principal Investigator Claire Ashton-James: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22425Study protocol  [email protected] 387820-(Uploaded-29-08-2024-17-10-14)-Protocol v2.0 22 05 24.docx



Results publications and other study-related documents

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

Documents added automatically
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