Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000745448p
Ethics application status
Submitted, not yet approved
Date submitted
22/05/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Research into a texting service for orthopaedic knee surgery patients
Scientific title
Acceptability and feasibility study of a texting service for orthopaedic knee surgery patients
Secondary ID [1] 314432 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee surgery 337456 0
Condition category
Condition code
Surgery 333829 333829 0 0
Other surgery
Musculoskeletal 334011 334011 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fioshealth Ltd has built a digital assistant that combines texting with artificial intelligence (AI) that allows patients to ask it questions and get trusted answers. This service has been created by surgeons who prepared a list of frequent patient questions along with tailored answers. AI matches the question that the patient asks to a question in its database and provides the surgeon’s answer. This texting service is accessible via SMS text and WhatsApp. They will be sent an introductory message via SMS or WhatsApp to begin using the service.

There is no minimum amount of time or questions that the participants will be asked to spend using the digital assistant. They will be given access to the assistant from enrolment until 3 weeks after their surgery, for a total of about 9-11 weeks.

Examples of questions and answers that may be provided through the digital assistant include:
"Hi [patient name], I am a digital assistant that is trained with clinical knowledge from University of Aucklnad. Feel free to message me anytime, I am here to help you with any questions or concerns you may have. If you'd like, you can also share more about your situation, such as what procedure you're preparing or any pain or symptoms you're experiencing so I can provide more specific answers."

"[patient name], during knee replacement, your damaged knee surfaces are removed and replaced with metal and plastic parts. Surgery takes 1-2 hours. Want to know more about recovery?"

"Recovery starts with walking (with help) soon after surgery. Most return to daily activities in 3 months, full strength 6-12 months. Need tips for home prep?"

"Prep your home by clearing walkways, setting up a comfy chair, and placing essentials within reach. Would you like a full checklist, [patient name]?"

These responses may send a link to a pre-approved video by Healthify about knee surgery.

The research team can log in to the FiosHealth portal to monitor and see whether messages have been delivered and received. WhatsApp also gives a double tick to indicate whether the messages have been received and read.


Intervention code [1] 331047 0
Treatment: Other
Intervention code [2] 331198 0
Treatment: Devices
Comparator / control treatment
There is no control group as this is an initial acceptability and feasibility study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341436 0
Feasability
Timepoint [1] 341436 0
Cumulative data will be assessed at the conclusion of the study.
Primary outcome [2] 341437 0
Acceptability
Timepoint [2] 341437 0
3 weeks after surgery (after 9-11 weeks of using texting service)
Secondary outcome [1] 447503 0
Illness perceptions
Timepoint [1] 447503 0
Change between baseline and 1 week before surgery (5-7 weeks of using texting service)
Secondary outcome [2] 447504 0
Surgical anxiety
Timepoint [2] 447504 0
Change between baseline and 1 week before surgery (5-7 weeks of using texting service)
Secondary outcome [3] 447505 0
Trust
Timepoint [3] 447505 0
1 week before surgery (5-7 days of using texting service) and 3 weeks after surgery (9-11 weeks of using texting service)
Secondary outcome [4] 447580 0
Phone calls, emails and visits to the clinic will be assessed together as a composite secondary outcome.
Timepoint [4] 447580 0
1 week before surgery (5-7 weeks of using texting service) and 3 weeks after surgery (9-11 weeks of using texting service)
Secondary outcome [5] 447581 0
Knee function
Timepoint [5] 447581 0
3 weeks after surgery (after 9-11 weeks of using texting service)
Secondary outcome [6] 449421 0
Satisfaction
Timepoint [6] 449421 0
1 week before surgery (5-7 days of using texting service) and 3 weeks after surgery (9-11 weeks of using texting service)

Eligibility
Key inclusion criteria
Eligible participants must be 18-years-old or older and have a mobile phone. They must be current patients of the surgeon researchers. They must be on the waitlist for knee surgery and give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients who are deemed by the surgeons not suitable for the texting service due to surgery being different to standard procedures.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 27065 0
New Zealand
State/province [1] 27065 0

Funding & Sponsors
Funding source category [1] 318961 0
University
Name [1] 318961 0
University of Auckland
Country [1] 318961 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321445 0
None
Name [1] 321445 0
Address [1] 321445 0
Country [1] 321445 0
Other collaborator category [1] 283524 0
Commercial sector/Industry
Name [1] 283524 0
FiosHealth Ltd
Address [1] 283524 0
Country [1] 283524 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317571 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 317571 0
Ethics committee country [1] 317571 0
New Zealand
Date submitted for ethics approval [1] 317571 0
16/06/2025
Approval date [1] 317571 0
Ethics approval number [1] 317571 0

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

Contacts
Principal investigator
Name 141462 0
Dr Elizabeth Broadbent
Address 141462 0
University of Auckland, MH&S Building 507, 28 Park Avenue, Grafton 1023
Country 141462 0
New Zealand
Phone 141462 0
+64 211227977
Fax 141462 0
Email 141462 0
[email protected]
Contact person for public queries
Name 141463 0
Kaavya Grover
Address 141463 0
University of Auckland, MH&S Building 507, 28 Park Avenue, Grafton 1023
Country 141463 0
New Zealand
Phone 141463 0
+64 211514846
Fax 141463 0
Email 141463 0
[email protected]
Contact person for scientific queries
Name 141464 0
Elizabeth Broadbent
Address 141464 0
University of Auckland, MH&S Building 507, 28 Park Avenue, Grafton 1023
Country 141464 0
New Zealand
Phone 141464 0
+64 211227977
Fax 141464 0
Email 141464 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.