Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000702213
Ethics application status
Approved
Date submitted
21/04/2018
Date registered
30/04/2018
Date last updated
7/07/2020
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological Coaching for Patients Undergoing Total Knee Replacements
Scientific title
The Efficacy of Psychological Coaching in Improving Patient Outcomes in Total Knee Arthroplasty
Secondary ID [1] 294553 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee arthroplasty 307331 0
Condition category
Condition code
Musculoskeletal 306440 306440 0 0
Osteoarthritis
Mental Health 306441 306441 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Psychological Coaching for Total Knee Replacement
This intervention will be with a 6-session manualised program with a psychologist, and will include components of psychoeducation, motivational interviewing, cognitive behaviour therapy, and relaxation therapy. The manualised program has been developed specifically for this study by the investigating team, which consists of an orthopaedic surgeon, clinical psychologists, and a provisional psychologist.
The intervention will be delivered individually, face-to-face. Each session will be approximately 1 hour and will occur weekly, except 1 week after surgery where there will be no sessions. The program will begin 2 weeks before surgery, and conclude 4 weeks after surgery. All patients will be followed up at 3, 6 and 12 months post-surgery. Psychologists delivering the program will be Provisional Psychologists under close supervision of Clinical Psychologists who are approved AHPRA supervisors. Provisional Psychologists delivering the intervention will attend regular meetings with a supervisor to review their sessions and troubleshoot problems. Sessions will be delivered at a combination of sites: either at a university clinic, or in hospitals.
Patients will be provided with information sheets (about their surgery process, pain, and mood), audio recordings (for relaxation exercises), and weekly monitoring worksheets.
Psychologists will be provided with a treatment manual, training workshops (face-to-face) and training videos.
Sessions will be video-recorded for supervision and clinical training purposes, and a random sample of recordings for each psychologist will be reviewed by investigators to ensure treatment fidelity. Feedback will be given to psychologists about treatment fidelity during regular supervision sessions.
Psychologists may revisit content from previous sessions, if patients needed more explanations or wanted clarification about concepts.
Intervention code [1] 300849 0
Rehabilitation
Comparator / control treatment
Patients will be randomly allocated to either the intervention group or control group. All patients participating in this study will be scheduled to undergo a total knee replacement.
Patients in the control group, who will not participate in intervention sessions. Patients in the control group will complete the same questionnaires as those in the intervention group, at the same time points as those in the intervention group: at 2 weeks pre-surgery, 4 weeks post-surgery, 3 months, 6 months, and 12 months post-surgery.
Patients in the control group will receive standard care from the hospitals. This will include standard consultations with surgeons, nurses, occupational therapists, physiotherapists, and other health professionals as part of standard procedure in hospitals before, during and after hospital admission.
Control group
Active

Outcomes
Primary outcome [1] 305450 0
The Forgotten Joint Score (FJS-12)
Timepoint [1] 305450 0
2 weeks pre-surgery, 4 weeks, 3 months, 6 months and 12 months post-surgery
Primary outcome [2] 305451 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 305451 0
2 weeks pre-suregery, 4 weeks, 3 months, 6 months and 12 months post-surgery
Secondary outcome [1] 345282 0
Pain Catastrophizing Scale (PCS) score
Timepoint [1] 345282 0
2 weeks pre-surgery, 4 weeks, 3 months, 6 months and 12 months post-surgery
Secondary outcome [2] 345283 0
Depression and Anxiety Stress Scale (DASS-21) scores:Depression subscale score
Timepoint [2] 345283 0
2 weeks pre-surgery, 4 weeks, 3 months, 6 months and 12 months post-surgery
Secondary outcome [3] 346153 0
Depression and Anxiety Stress Scale (DASS-21) scores: Anxiety subscale score
Timepoint [3] 346153 0
2 weeks pre-surgery, 4 weeks, 3 months, 6 months and 12 months post-surgery
Secondary outcome [4] 346154 0
Depression and Anxiety Stress Scale (DASS-21) scores: Stress subscale score
Timepoint [4] 346154 0
2 weeks pre-surgery, 4 weeks, 3 months, 6 months and 12 months post-surgery

Eligibility
Key inclusion criteria
Patients on a waitlist to undergo a total knee arthroplasty will be eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have the following will be excluded from this study:
• Delusional or psychotic thinking
• Ongoing psychiatric disorder (e.g. Schizophrenia)
• Substance abuse
• Traumatic head injury
• Difficulties reading/writing/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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization- Blocks of 15.
Each block was randomized using a software to produce random permutations (1s and 0s), where there would be five 1s and ten 0s.
The number 1 would indicate that a patient would be allocated to the intervention group, and 0 would indicate that a patient would be allocated to the control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A prospective power analysis was conducted to determine the number of participants required in each group. The primary outcome of the analysis was scores on the Forgotten Joint Score, based on a clinically relevant difference of 10 points. A one-tailed analysis with 50 participants in each group yielded a power of 0.80 with alpha level 0.05 and effect size of 0.5 (we expect the mean of psychological coaching group to be larger than treatment group). In a two-tailed analysis, 48 participants were required in the psychological coaching group and 96 participants were required in the standard treatment group, to yield a power of 0.80, effect size of 0.5 and alpha level of 0.05 with a 2:1 ratio (i.e. for every 2 participants in standard treatment group, there will be 1 participant in the psychological coaching group).
It is anticipated that we will use multi-level modelling for statistical analysis, as we will be dealing with longitudinal data.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
11/06/2018
Actual
19/07/2018
Date of last participant enrolment
Anticipated
Actual
12/07/2019
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
150
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 299176 0
University
Name [1] 299176 0
University of Western Australia
Country [1] 299176 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley 6009, Western Australia
Country
Australia
Secondary sponsor category [1] 298434 0
None
Name [1] 298434 0
Address [1] 298434 0
Country [1] 298434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300100 0
Sir Charles Gairdner and Osborne Park Health Care Group
Ethics committee address [1] 300100 0
Ethics committee country [1] 300100 0
Australia
Date submitted for ethics approval [1] 300100 0
Approval date [1] 300100 0
04/08/2016
Ethics approval number [1] 300100 0
Ethics committee name [2] 300198 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [2] 300198 0
Ethics committee country [2] 300198 0
Australia
Date submitted for ethics approval [2] 300198 0
Approval date [2] 300198 0
13/06/2017
Ethics approval number [2] 300198 0

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

Contacts
Principal investigator
Name 82566 0
Prof Markus Kuster
Address 82566 0
Perth Orthopaedics and Sports Medicine Centre
31 Outram Street
West Perth,
Western Australia 6005
Country 82566 0
Australia
Phone 82566 0
+61892124200
Fax 82566 0
Email 82566 0
[email protected]
Contact person for public queries
Name 82567 0
Samantha Bay
Address 82567 0
School of Psychological Science,
University of Western Australia, M304,
35 Stirling Highway,
Crawley 6009 Western Australia
Country 82567 0
Australia
Phone 82567 0
+61864883277
Fax 82567 0
Email 82567 0
[email protected]
Contact person for scientific queries
Name 82568 0
Samantha Bay
Address 82568 0
School of Psychological Science,
University of Western Australia, M304,
35 Stirling Highway,
Crawley 6009 Western Australia
Country 82568 0
Australia
Phone 82568 0
+61864883277
Fax 82568 0
Email 82568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants were told that only group data will be published; no individual data will be made public. Data collected is considered to be sensitive in nature to some participants; e.g. their level of anxiety and depression symptoms experienced.


What supporting documents are/will be available?

No Supporting Document Provided



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.