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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
Scientific title
Evaluating the implementation and effectiveness of a digital intervention on pain and reliance on opioids after total knee replacement surgery
Secondary ID [1] 312177 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 333831 0
Condition category
Condition code
Musculoskeletal 330506 330506 0 0
Osteoarthritis
Surgery 331427 331427 0 0
Other surgery
Anaesthesiology 331428 331428 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328619 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 338273 0
Pain intensity
Timepoint [1] 338273 0
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.
Secondary outcome [1] 435239 0
Pain-related distress
Timepoint [1] 435239 0
Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [2] 438660 0
Self-reported adherence to behavioural pain management strategies
Timepoint [2] 438660 0
3 days, 3 weeks, 6 weeks, 3 months, and 6 months after surgery
Secondary outcome [3] 438661 0
Perceived social isolation
Timepoint [3] 438661 0
Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [4] 438662 0
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.
Timepoint [4] 438662 0
3 days, 3 weeks, and 6 weeks after surgery
Secondary outcome [5] 438663 0
Knee pain and function (total score of the Oxford Knee Score questionnaire). Note: Knee pain and function will be assessed as a composite outcome.
Timepoint [5] 438663 0
Baseline, 3 months and 6 months after surgery
Secondary outcome [6] 438664 0
Health-related quality of life
Timepoint [6] 438664 0
Baseline, and 6 weeks, 3 months, and 6 months after surgery
Secondary outcome [7] 438665 0
Pain self-efficacy
Timepoint [7] 438665 0
Baseline, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [8] 438666 0
Opioid dose
Timepoint [8] 438666 0
Baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
The person who is involved in recruitment phase cannot access the randomisation table (concealed allocation) as defined in REDCap user rights.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26956 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43028 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 316544 0
Charities/Societies/Foundations
Name [1] 316544 0
HCF (The Hospitals Contribution Fund of Australia)
Country [1] 316544 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 318726 0
None
Name [1] 318726 0
Address [1] 318726 0
Country [1] 318726 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315337 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315337 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 315337 0
Australia
Date submitted for ethics approval [1] 315337 0
15/07/2024
Approval date [1] 315337 0
Ethics approval number [1] 315337 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134382 0
A/Prof CLAIRE ASHTON-JAMES
Address 134382 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 134382 0
Australia
Phone 134382 0
+61410365816
Fax 134382 0
Email 134382 0
[email protected]
Contact person for public queries
Name 134383 0
Dr Ali Gholamrezaei
Address 134383 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 134383 0
Australia
Phone 134383 0
+61480490896
Fax 134383 0
Email 134383 0
[email protected]
Contact person for scientific queries
Name 134384 0
Dr Ali Gholamrezaei
Address 134384 0
Ground Floor Douglas Building, Royal North Shore Hospital, St Leonards, NSW, AUSTRALIA, 2065
Country 134384 0
Australia
Phone 134384 0
+61480490896
Fax 134384 0
Email 134384 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


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.