Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001867280
Ethics application status
Approved
Date submitted
23/10/2018
Date registered
16/11/2018
Date last updated
5/03/2019
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of a psychologically informed physiotherapy for people awaiting knee replacement surgery.
Scientific title
The KOMPACT-P study: Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy- Pilot study.
Secondary ID [1] 296363 0
Nil known
Universal Trial Number (UTN)
U1111-1222-5248
Trial acronym
The KOMPACT-P study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 310094 0
Total knee arthroplasty 310096 0
Condition category
Condition code
Musculoskeletal 308838 308838 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 308839 308839 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PACT group: Participants will attend 3 additional one-to-one sessions at their local physiotherapy outpatient department pre-operatively of 60 mins, 30 mins and 30 mins duration respectively over a 3 month period, with appointments 6 weeks apart.
The fourth session of 20 mins duration will occur during their inpatient stay when the physiotherapist will attend to them in the ward setting. All physiotherapists conducting the intervention will have more than 3 years experience in musculoskeletal physiotherapy. They will also receive 16 hours training in the ACT method generally through an accredited ACT training provider. In addition, they will engage in 1 day of trial specific training in PACT, which will be provided by psychologists and physiotherapists experienced in developing and using the PACT method, and will be supported with a therapist training manual. All participants will be supplied with a patient manual, which supports the approach taken during the individual sessions. 'The initial session will include a thorough clinical assessment, and ongoing discussion between the therapist and participant to identify key values of the participant, linking these to behaviour goals around physical activity, action planning, identification of barriers and facilitators and prescription of one specific strength exercise. The strength exercise will target knee extensor and hip abductor strength, and the exact exercise and resistance will be personalised by the therapist based on an 8-10RM prescription.
Review sessions will explore progress made with regards to behavioural goals, exploring barriers/facilitators, goal review, and progression of exercises. All sessions will be conducted with a therapeutic stance aligned with Acceptance and Commitment Therapy principles as equal, respectful, empathetic and positive. Participants in this group will also receive the usual care treatment. All sessions will be recorded and assessed by the supervising clinical psychologist for intervention fidelity, including adherence and competence, using a standardised checklist developed a priori. Participating therapists will undergo monthly supervision sessions with the supervising psychologists in person or via videoconferencing.
Intervention code [1] 312692 0
Behaviour
Intervention code [2] 312693 0
Rehabilitation
Intervention code [3] 312694 0
Lifestyle
Comparator / control treatment
All participants will receive usual care, which is attending a face-to-face one hour education class for patients and carers regarding the joint replacement pathway 3 months before surgery. It describes the surgical procedure, health professionals involved at all stages of the knee replacement surgery pathway, information regarding 1-2 relevant exercises used post-operatively, and expectations for recovery in the inpatient and outpatient stages. They will also receive a usual care patient handbook which provides the same information in a written format which is the resource used in standard care at Blacktown Mt Druitt Hospitals. This will be conducted by a physiotherapist with 2 or more years experience who is familiar with local joint replacement pathway procedures, in the local physiotherapy department.
Control group
Active

Outcomes
Primary outcome [1] 307811 0
Safety: composite primary outcome
-Length of stay measured in calendar days from day of admission to day of discharge from the medical record (quantitative outcome).
-Complications after surgery: incidence of documented and unexpected changes in health resulting in alterations to health care provision eg venous thromboembolism resulting in extra ultrasound and changes to anticoagulant medication (quantitative outcome), wound infection requiring increased antibiotics and increased access to nursing care.
Timepoint [1] 307811 0
6 weeks and 6 months after total knee arthroplasty surgery
Primary outcome [2] 307812 0
Feasibility: composite primary outcome (quantitative)
• Recruitment rate as a percentage of all eligible potential participants.
• Time to recruit all participants (calendar months elapsed from recruitment of first participant to last participant).
• Retention of participants at 6 months after surgery as a percentage of all participants recruited.
• Attendance rates at treatment group appointments as a percentage of all scheduled appointments
• Intervention fidelity adherence and competence as a percentage of all checklist items after the 30th participant recruited in the treatment group.
Timepoint [2] 307812 0
1 month before surgery
6 months after surgery for the last participant
Primary outcome [3] 307814 0
Acceptability: composite primary outcome (qualitative and quantitative)
•Patient reported treatment credibility using five questions based on those hypothesised by Borkovec and Nau (quantitative)
•Comparison of patient reported outcomes between the treatment and control groups including: Oxford Knee Score; International Physical Activity Questionnaire for the Elderly; EQ-5D-5L; Numerical Pain Rating Scale; Depression Anxiety and Stress Scale-21; Chronic Pain Acceptance Questionnaire-8; Committed Action Questionnaire-8; Brief Resilience Scale; Pain Self-Efficacy Questionnaire-2; Life Satisfaction Scale (quantitative)
•Comparison of physical performance measures between the treatment and control groups including: 30 second chair stand test; 6 minute walk test
Timepoint [3] 307814 0
1 month before surgery
6 months after surgery
Secondary outcome [1] 353006 0
Hospital length of stay: number of calendar days from date of admission to date of discharge as per clinical documentation in the medical record.
Timepoint [1] 353006 0
On discharge from hospital
Secondary outcome [2] 353007 0
Incidence of post-operative complications requiring changed clinical care as per the clinical documentation
Timepoint [2] 353007 0
6 weeks and 6 months after surgery
Secondary outcome [3] 353009 0
mean Brief Resilience Scale score
Timepoint [3] 353009 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [4] 353010 0
Committed Action Questionnaire-8 (CAQ-8) total score
Timepoint [4] 353010 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [5] 353011 0
Chronic Pain Acceptance Questionnaire-8 (CAQ-8) total score
Timepoint [5] 353011 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [6] 353013 0
Pain Self-Efficacy Questionnaire-2 (PSEQ-2) total score
Timepoint [6] 353013 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [7] 353014 0
Depression, Anxiety and Stress Score-21 (DASS-21) total score in each domain
Timepoint [7] 353014 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [8] 353015 0
Treatment credibility questions based on Borkovec and Nau (1972)
Timepoint [8] 353015 0
1 month before surgery
Secondary outcome [9] 353016 0
Self reported knee function using Oxford Knee Score total score
Timepoint [9] 353016 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [10] 353017 0
Worst pain in the past 24 hours measured using the Numerical pain rating scale (NPRS) total score
Timepoint [10] 353017 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [11] 353019 0
Self-reported physical activity using the International Physical Activity Questionnaire for the Elderly (IPAQ-E) for total activity levels.
Timepoint [11] 353019 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [12] 353021 0
Quality of life using the EQ-5D-5L using both coded score and VAS responses
Timepoint [12] 353021 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [13] 353023 0
Life satisfaction score using a numerical rating scale from zero to ten.
Timepoint [13] 353023 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [14] 353025 0
Total metres walked during the 6 minute walk test.
Timepoint [14] 353025 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [15] 353026 0
Number of repetitions during the 30 second chair stand test.
Timepoint [15] 353026 0
Baseline, 1 month before surgery, 6 weeks after surgery, 6 months after surgery
Secondary outcome [16] 353027 0
Total number of physiotherapy occasions of service during the inpatient period measured using the statistical record routinely collected by NSW Health clinicians through Cerner Powerchart.
Timepoint [16] 353027 0
6 weeks after surgery
Secondary outcome [17] 353028 0
Utilisation of inpatient rehabilitation as a binary outcome (yes/no)
Timepoint [17] 353028 0
6 weeks after surgery
Secondary outcome [18] 353029 0
Satisfaction with knee replacement surgery as a binary outcome (yes/no)
Timepoint [18] 353029 0
6 weeks and 6 months after surgery

Eligibility
Key inclusion criteria
Subjects will be considered eligible for inclusion in this study if they are:
• Over 18 years old.
• Accepted on to the surgical waiting list for an elective primary unilateral total knee arthroplasty for osteoarthritis at Blacktown Mt Druitt hospital during the period of recruitment.
• Attending pre-admission appointments at the same site as their surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they
• Have moderate or severe cognitive impairment pre-operatively on testing.
• Reside outside of the local government areas covered by WSLHD.
• Are having a revision TKA.
• Are having a bilateral TKA.
• Do not attend pre-admission assessment and education appointments.
• Have plans to reside outside the WSLHD local government area on discharge from hospital.
• Have further orthopaedic surgery planned in the next six months.
• Report symptoms indicative of acute psychological risk, suicidal ideation or psychosis.
• Report any current use of illicit substances, or alcohol intake greater than 14 units per week.

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 will be conducted by an offsite investigator according to a pre-determined stratified randomisation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by minimisation with stratification for psychological heath (DASS-21), sex and site.
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
Randomization will be in a 2:1 ratio, favouring the treatment group.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is a mixed methods pilot randomized controlled trial.
Categorical baseline variables will be summarized with percentages. Continuous baseline variables will be summarized dependent on their distribution: normally distributed variables will be summarized using mean, standard deviation and 95% confidence interval, non-normally distributed variables will be summarized using median and interquartile range.
Safety of the PACT intervention will be assessed by three quantitative methods: psychological health outcomes before and after the PACT intervention before TKA surgery is performed, length of stay and complications after TKA surgery for the first 6 months.
Feasibility of the PACT intervention will be assessed by quantitative and qualitative methods. Quantitative methods will examine recruitment rates, time for sufficient participant recruitment, retention rates, attendance at appointments, and intervention fidelity. Qualitative methods will explore feasibility, enablers and barriers to the intervention from a therapist and participant perspective.
Acceptability of the PACT intervention will be assessed by both quantitative and qualitative methods. Qualitative methods will include analysis of treatment credibility scores, patient reported outcome measures and physical performance measures. Qualitative methods will explore acceptability of the intervention and training from a therapist and participant perspective.
We aim to recruit 51 people to our pilot study. This is adequate to test the safety, acceptability and effectiveness of the PACT intervention and of performing a randomised controlled trial at these sites, allow for any learning effects in the therapists administering the novel PACT intervention, and allow adequate randomisation with stratification. This will also provide sufficient data regarding estimate of effect size and variation for the treatment group which will inform a fully powered randomised controlled trial in the future. We are particularly interested in the effect of treatment on the outcomes of hospital length of stay and complications, but consideration of other outcomes will guide their use in a future, fully powered randomised controlled trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12197 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 12198 0
Mount Druitt Hospital - Mount Druitt
Recruitment postcode(s) [1] 24368 0
2148 - Blacktown
Recruitment postcode(s) [2] 24369 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 300965 0
Hospital
Name [1] 300965 0
Western Sydney Local Health District
Country [1] 300965 0
Australia
Funding source category [2] 300966 0
University
Name [2] 300966 0
University of Sydney
Country [2] 300966 0
Australia
Primary sponsor type
Hospital
Name
Western Sydney Local Health District- Blacktown Mt Druitt Hospital
Address
c/o Research and Education Network WSLHD
Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 300540 0
University
Name [1] 300540 0
University of Sydney, Faculty of Health Sciences
Address [1] 300540 0
Faculty of Health Sciences
East St, Lidcombe NSW 2141
Country [1] 300540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301729 0
Western Sydney Local Health District HREC
Ethics committee address [1] 301729 0
c/o Research and Education Network
Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 301729 0
Australia
Date submitted for ethics approval [1] 301729 0
17/10/2018
Approval date [1] 301729 0
13/12/2018
Ethics approval number [1] 301729 0
HREC/18/WMEAD/440

Summary
Brief summary
This study is the first to test a new physiotherapy approach to preparing for knee replacement surgery. This new approach is called PACT- Physiotherapy informed by Acceptance and Commitment Therapy. This is a method often used by psychologists to help people experiencing a range of issues that affect their mental health. This study is a pilot study, testing the new approach in 51 people and assessing results from a patient, therapist and hospital perspective before we use this approach in a larger study or in clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87914 0
Dr Bijoy Thomas
Address 87914 0
Orthopaedic Department
Blacktown Hospital
PO BOX 792, Seven Hills NSW 1830
Country 87914 0
Australia
Phone 87914 0
+61 2 9881 8000
Fax 87914 0
Email 87914 0
bijoy.thomas@health.nsw.gov.au
Contact person for public queries
Name 87915 0
Ms Marie March
Address 87915 0
c/o Physiotherapy Department
Blacktown Hospital
PO BOX 792, Seven Hills NSW 1830
Country 87915 0
Australia
Phone 87915 0
+61 2 9881 8302
Fax 87915 0
Email 87915 0
Marie.March@health.nsw.gov.au
Contact person for scientific queries
Name 87916 0
Ms Marie March
Address 87916 0
c/o Physiotherapy Department
Blacktown Hospital
PO BOX 792, Seven Hills NSW 1830
Country 87916 0
Australia
Phone 87916 0
+61 2 9881 8302
Fax 87916 0
Email 87916 0
Marie.March@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be collected in a the context of an existing health service and is subject to privacy regulations governing medical records. Access to data will be considered on a case by case basis on consultation with local researchers and the local human ethics committee.


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.