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Trial registered on ANZCTR
Registration number
ACTRN12624001060538p
Ethics application status
Submitted, not yet approved
Date submitted
16/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of a digital intervention on pain and reliance on opioids after total knee replacement surgery
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Scientific title
Evaluating the implementation and effectiveness of a digital intervention on pain and reliance on opioids after total knee replacement surgery
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Secondary ID [1]
312177
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement
333831
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Condition category
Condition code
Musculoskeletal
330506
330506
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0
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Osteoarthritis
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Surgery
331427
331427
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0
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Other surgery
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Anaesthesiology
331428
331428
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Up to one week prior to their scheduled surgery date, participants in the intervention group will receive a short (10 minute) psychoeducational video (via text message containing a hyperlink) addressing patients confidence and motivation to use non-pharmacological pain self-management strategies (e.g. physical activity, pacing, social engagement) to manage pain in combination with prescribed medications. Each day after surgery for three weeks, participants will then receive one text message (between 160 to 320 characters) providing them with reassurance (validation, encouragement, support) and reminders about pain and how to effectively manage pain by using pain self-management strategies. The messages serve to reinforce the material in the psychoeducational video. Adherence to the intervention (watching the video, reading text messages) will be self-reported by patients in a survey at the end of the trial.
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Intervention code [1]
328619
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Behaviour
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Comparator / control treatment
The control group will receive the same psychoeducation video (via text message containing a hyperlink) prior to surgery as the intervention group, but they will not receive the daily SMS text messages. Participants in the active control group will ostensibly receive the same information as the intervention group, but they will receive it only via video, and without reminders.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain intensity
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Assessment method [1]
338273
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11-point Visual Analogue Scale
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Timepoint [1]
338273
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Baseline (2 weeks preoperatively), 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery. Measures at 3 days, 3 weeks, and 6 weeks will be used to test the overall effect as the primary hypothesis testing method.
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Secondary outcome [1]
435239
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Pain-related distress
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Assessment method [1]
435239
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Concerns About Pain Scale-2
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Timepoint [1]
435239
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Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [2]
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Self-reported adherence to behavioural pain management strategies
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Assessment method [2]
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6-point Likert scale
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Timepoint [2]
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3 days, 3 weeks, 6 weeks, 3 months, and 6 months after surgery
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Secondary outcome [3]
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Perceived social isolation
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Assessment method [3]
438661
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PROMIS-2a
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Timepoint [3]
438661
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Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [4]
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Changes in knee pain and function (total score of the Oxford Arthroplasty Early Change Score questionnaire). Note: Changes in knee pain and function will be assessed as a composite outcome.
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Assessment method [4]
438662
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Oxford Arthroplasty Early Change Score (OACS)
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Timepoint [4]
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3 days, 3 weeks, and 6 weeks after surgery
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Secondary outcome [5]
438663
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Knee pain and function (total score of the Oxford Knee Score questionnaire). Note: Knee pain and function will be assessed as a composite outcome.
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Assessment method [5]
438663
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Oxford Knee Score (OKS)
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Timepoint [5]
438663
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Baseline, 3 months and 6 months after surgery
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Secondary outcome [6]
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Health-related quality of life
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Assessment method [6]
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EuroQol Group EQ-5D™
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Timepoint [6]
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Baseline, and 6 weeks, 3 months, and 6 months after surgery
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Secondary outcome [7]
438665
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Pain self-efficacy
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Assessment method [7]
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Pain Self-Efficacy Questionnaire
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Timepoint [7]
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Baseline, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [8]
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Opioid dose
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Assessment method [8]
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Opioid use at baseline and during hospitalisation (Day 3) will be retrieved from hospital records and converted to an oral morphine equivalent daily dose (OMEDD) using a validated calculator (www.opioidcalculator.com.au). Opioid use after discharge (3 weeks onwards) will be self-reported and converted to OMEDD using the same procedure.
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Timepoint [8]
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Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery
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Eligibility
Key inclusion criteria
- patients who are scheduled for Total Knee Replacement (TKR) surgery
- own a mobile phone with access to the internet
- capable of watching a 10-minute video with audio and subtitles, receiving, reading, and understanding short SMS text messages
- capable in completing brief online surveys
- able to provide independent consent to participate
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- cognitive impairment, visual impairment, or a mental health condition affecting their ability to provide independent consent or affecting their ability to understand and complete survey measures
- difficulty reading or understanding English
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who is involved in recruitment phase cannot access the randomisation table (concealed allocation) as defined in REDCap user rights.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
REDCap will automatically assign consented participants to either the intervention or active control group using a randomisation table generated by Research Randomiser (https://www.randomizer.org/, with ratio of 1:1) and uploaded to the REDCap.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
To evaluate primary and secondary effectiveness outcomes (pain, functioning, opioid use), a linear mixed-effects model analysis will be used. The main effect of the group will be tested to estimate the overall difference in outcomes between the two groups across all timepoints (Day 3, Week 3, and Week 6 for the study primary hypothesis and other timepoints for secondary and explorative analyses). All analyses will be conducted using SAS software (v 9.4), and according to the intent-to-treat principle (data of all participants who are randomised will be included in the analyses).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/10/2026
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Actual
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Date of last data collection
Anticipated
1/04/2027
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26956
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
43028
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
316544
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Charities/Societies/Foundations
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Name [1]
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HCF (The Hospitals Contribution Fund of Australia)
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Address [1]
316544
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
318726
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None
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Name [1]
318726
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Address [1]
318726
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Country [1]
318726
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315337
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
315337
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
315337
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Australia
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Date submitted for ethics approval [1]
315337
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15/07/2024
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Approval date [1]
315337
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Ethics approval number [1]
315337
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Summary
Brief summary
The efficacy and safety of digitally delivered pain self-management interventions for reducing pain after surgeries, including total knee replacement (TKR), have been demonstrated in several randomised controlled trials. However, little is known about the feasibility and effectiveness of these interventions in Australian hospital settings. The current project evaluates the implementation and effectiveness of an mHealth intervention designed to support patients’ engagement with pain self-management after TKR surgery. Consenting patients (N = 130) who are scheduled to undergo TKR surgery will be randomised to receive either a psychoeducational video prior to surgery, and one SMS text message per day for 3 weeks after surgery, or the pre-surgery psychoeducational video only. Both groups will continue to receive usual care. Outcome measures including pain intensity (primary), opioid dose, pain-related distress, and perceived social isolation will be recorded at baseline, 3 days, 3 weeks, 6 weeks, 3 months, and 6 months after surgery using self-reported surveys. Pain self-efficacy will be measured at 6 week, 3 months and 6 months post-surgery. Implementation outcomes will be evaluated using mixed (quantitative-qualitative) methods. This trial represents a first step towards the translation of digitally delivered non-pharmacological acute pain management in the Australian healthcare system.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof CLAIRE ASHTON-JAMES
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Address
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Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
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Country
134382
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Australia
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Phone
134382
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+61410365816
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Fax
134382
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Email
134382
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[email protected]
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Contact person for public queries
Name
134383
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Dr Ali Gholamrezaei
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Address
134383
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Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
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Country
134383
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Australia
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Phone
134383
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+61480490896
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Fax
134383
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Email
134383
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[email protected]
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Contact person for scientific queries
Name
134384
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Dr Ali Gholamrezaei
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Address
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Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
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Country
134384
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Australia
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Phone
134384
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+61480490896
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Fax
134384
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Email
134384
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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