ANZCTR - Registration

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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]

None

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

Physical Medicine / Rehabilitation

Physiotherapy

Mental Health

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]

Behaviour

Intervention code [2]

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]

Perceived self-efficacy to complete exercises despite pain

Assessment method [1]

Assessed by clinician, who will ask participants “At the moment, how confident do you feel that you can complete your exercises at home despite pain? Please indicate your level of confidence from 0-100%”.

Timepoint [1]

The first and second appointment of week 3 post-surgery, the first and second appointment of week 4 post-surgery.

Secondary outcome [1]

Exercise adherence

Assessment method [1]

Adherence to prescribed physiotherapy knee exercises will be assessed using a daily exercise diary given by the clinician to participants after each appointment .

Timepoint [1]

Daily, throughout week 3 and 4 post-surgery

Secondary outcome [2]

Perceived self-efficacy to participate in daily living activities despite pain

Assessment method [2]

Assessed by clinician, who will ask participants clinicians will ask participants “At the moment, how confident do you feel that you can participate in social roles and activities of daily living despite the pain? Please indicate your level of confidence from 0-100%”

Timepoint [2]

The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.

Secondary outcome [3]

Pain intensity

Assessment method [3]

Numerical Rating Scale (NRS; verbal - during appointments), Visual Analog Scale (VAS; written - in exercise diary)

Timepoint [3]

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]

Knee range of motion (active and passive)

Assessment method [4]

Measured by physiotherapists, using a goniometer to record angle in degrees for both active and passive knee range of motion

Timepoint [4]

The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.

Secondary outcome [5]

Medication use

Assessment method [5]

Clinicians will ask participants if they are currently taking any medication for the pain, and if so, what and how often.

Timepoint [5]

The first and second appointment of week 3 post-surgery, and the first and second appointment of week 4 post-surgery.

Secondary outcome [6]

Patient feedback on the intervention

Assessment method [6]

Online qualitative survey designed specifically for the study, consisting of 5 questions

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Hospital Geelong - Waurn Ponds

Recruitment postcode(s) [1]

3216 - Waurn Ponds

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/04/2024

Approval date [1]

23/05/2024

Ethics approval number [1]

2024/ETH00887

Summary

Brief summary

The study aims to examine the short-term effectiveness of a brief reminiscence (mastery experience) intervention on self-efficacy to do prescribed exercises despite pain and adherence to prescribed exercises for patients recovering from total knee replacement (TKR). Participants who receive the intervention are expected to have higher self-efficacy to complete exercises despite pain, higher self-reported exercise adherence, and greater reduction in pain intensity than those in the waitlist control group.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Claire Ashton-James

Address

Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 410 365 816

claire.ashton-james@sydney.edu.au

Contact person for public queries

Name

Claire Ashton-James

Address

Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 410 365 816

claire.ashton-james@sydney.edu.au

Contact person for scientific queries

Name

Claire Ashton-James

Address

Pain Management Research Centre, Lvl 2 Douglas building, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065

Country

Australia

Phone

+61 410 365 816

claire.ashton-james@sydney.edu.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Anyone upon reasonable request to the primary investigator

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified outcome data

What types of analyses could be done with individual participant data?

• For meta-analyses and sub-analyses

When can requests for individual participant data be made (start and end dates)?

From:
Upon publication of the data, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Principal Investigator Claire Ashton-James: claire.ashton-james@sydney.edu.au

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22425	Study protocol			claire.ashton-james@sydney.edu.au		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

No additional documents have been identified.

Trial Review

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