Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000907347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/06/2026
Date registered
Help: Date registered
23/07/2026
Date last updated
Help: Date last updated
23/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/07/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Comparing Digitally Delivered Interactive Patient Education to Standard Education for Surgical Prehabilitation on Health Information Comprehension
Scientific title
A Randomised Controlled Trial Comparing Digitally Delivered Interactive Patient Education to Standard Education for Surgical Prehabilitation on Health Information Comprehension
Additional trial identifiers [1] 316337 0
[email protected]
Universal Trial Number (UTN)
U1111-1334-3533
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Pre-operative care for major surgery 340400 0
Condition category
Condition code
Surgery 336608 336608 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
AI-Driven Interactive Digital Pre-Surgery Education

Materials: Standard written patient-education content (covering pre-operative home exercises, diet and nutrition, recovery in hospital, pain control, medications, and recovery at home) is converted into short interactive digital modules using a locally-run AI algorithm. Each module includes tailored multiple-choice questions with immediate feedback, optional voice narration, and stock imagery, delivered via the RedCap platform.

Individualisation: Content topics are standardised across major surgery types (i.e. not tailored to the specific procedure).

Procedures: participants are first sent with the email link to the pre-education knowledge assessment survey, they need to complete it before they can access all educational modules. Participants then complete the modules via smartphone, tablet, or computer, individually and remotely.

Frequency and duration: 12 modules are all unlocked immediately after patients complete the pre-education baseline knowledge assessment. Then they are informed that they have exactly 5 days to review all modules. After 5 days, patients are given the survey link to complete the post-education knowledge assessment survey which takes approximately 20 minutes.

Location: Participant's home or location of choice, via personal or study-loaned device.

Adherence assessment: Automatically tracked via RedCap — module completion rate, time spent per module, and total session duration.
Intervention code [1] 332999 0
Behaviour
Intervention code [2] 334721 0
Other interventions
Description of the comparator or control
Standard Physical Materials-Based Education (Active Control)

Materials: A 24-page printed booklet (covering the same topics as the intervention) plus a USB drive with corresponding instructional videos. Content is general, standardised across surgery types — not individualised to the specific procedure.

Procedures: All materials handed to the patient in a single session at enrolment; patients read/watch at their own pace and self-report completion via checkbox sections in the booklet, returned at hospital admission. A separate pre-education knowledge assessment survey is sent to patient's email address. Patient can complete it during the enrolment or later at they own discretion.

Provider: Clinical staff/research coordinators.

Mode of delivery: Face-to-face handover; self-directed consumption.

Frequency and duration: Single handover at enrolment; Patients are informed that after complete the pre-education knowledge assessment, they have exactly 5 days to review the booklet. Then a survey link for post-education knowledge assessment is sent to patient's email address.

Location: Provided at Nepean Hospital; consumed at the patient's home.

Adherence assessment: Self-reported checkbox completion, collected at hospital admission.
Control group
Active

Outcomes
Primary outcome [1] 344118 0
Outcome Name: Knowledge comprehension score
Timepoint [1] 344118 0
Baseline (at study recruitment when patients complete the pre-intervention survey, then patients have exactly 5 days to complete the intervention so that the it does not conflict with the surgery that is scheduled 1-8 weeks after recruitment), and post-intervention occurs exactly 5 days after patients complete the pre-intervention knowledge assessment survey.
Secondary outcome [1] 456802 0
Pre-surgery anxiety levels
Timepoint [1] 456802 0
Baseline (at recruitment) and 3-5 workdays before surgery admission (standardized timepoint).
Secondary outcome [2] 456803 0
Post-discharge healthcare utilization
Timepoint [2] 456803 0
2 weeks post-discharge.
Secondary outcome [3] 456804 0
Patient acceptance of the digital intervention (Digital Group)
Timepoint [3] 456804 0
exactly 5 days after patients complete the pre-intervention knowledge assessment survey which begins the intervention.
Secondary outcome [4] 456805 0
Patient satisfaction with materials (Physical Group)
Timepoint [4] 456805 0
exactly 5 days after patients complete the pre-education knowledge assessment survey which we reminds patient to complete before start reading the booklet.
Secondary outcome [5] 456806 0
Adherence to educational materials (Digital Group)
Timepoint [5] 456806 0
Measured continuously during the intervention period and assessed immediately post-intervention (collected upon hospital admission).
Secondary outcome [6] 464868 0
Adherence to educational materials (self-reported, control group)
Timepoint [6] 464868 0
The self-reported completion diary is collected upon hospital admission.

Eligibility
Key inclusion criteria
Age: Adults aged 18 years or older.

Surgical Candidate: Patients scheduled to undergo a major surgical procedure (defined as an elective inpatient surgery requiring a hospital stay of at least 24 hours or more).

Surgery Timing: The planned surgery must be scheduled to take place between 1 and 8 weeks after initial contact/enrollment.

Cognitive Capacity: Patients must have the ability to understand and comprehend general health information related to their upcoming surgery.

Consent Capacity: Patients must be able to provide informed consent, which includes understanding the study aims, procedures, and the intervention allocation (digital vs. physical).

Prehabilitation Participation: Patients must be willing and able to participate in the patient education component of the pre-surgery program, regardless of whether they are assigned to the physical or digital group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Consent: Inability or unwillingness to provide informed consent.

Cognitive Impairment: Significant cognitive impairment that affects the comprehension of health information, the ability to retain pre-surgery instructions, or the reliability of self-reported data (e.g., dementia).

Technology Barriers: Inability or unwillingness to use digital technology for intervention delivery (digital group) and/or completing study assessments (e.g., lack of access to smartphones/tablets, aversion to digital tools).

Surgery Timing: Surgery scheduled outside the defined time window (i.e., less than 1 week or more than 8 weeks post-initial contact).

Prior Exposure: Participants who have already received physical education materials prior to enrollment in this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed using a central, secure, web-based randomisation module within the REDCap data management system. The allocation sequence is hidden from the recruiting investigator and is only revealed after the participant is formally enrolled and their baseline details are locked in the database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the randomisation sequence is computer-generated using a Microsoft Excel random number generator, salted with the time of generation.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/06/2026
Date of last participant enrolment
Anticipated
30/10/2026
Actual
Date of last data collection
Anticipated
20/11/2026
Actual
Sample size
Target
56
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29748 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 46094 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 320940 0
Government body
Name [1] 320940 0
Nepean Blue Mountains Local Health District
Country [1] 320940 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325202 0
Government body
Name [1] 325202 0
Nepean Blue Mountains Local Health District
Address [1] 325202 0
Country [1] 325202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319480 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 319480 0
Ethics committee country [1] 319480 0
Australia
Date submitted for ethics approval [1] 319480 0
21/10/2025
Approval date [1] 319480 0
19/12/2025
Ethics approval number [1] 319480 0
2025/ETH01646

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

Contacts
Principal investigator
Name 147458 0
Dr Anwar Hassan
Address 147458 0
Physiotherapy Department, Nepean Hospital, Nepean Blue Mountains LHD PO Box 63, Penrith, NSW, 2751
Country 147458 0
Australia
Phone 147458 0
+61 2 4734 2140
Fax 147458 0
Email 147458 0
[email protected]
Contact person for public queries
Name 147459 0
Anwar Hassan
Address 147459 0
Physiotherapy Department, Nepean Hospital, Nepean Blue Mountains LHD PO Box 63, Penrith, NSW, 2751
Country 147459 0
Australia
Phone 147459 0
+61 2 4734 2140
Fax 147459 0
Email 147459 0
[email protected]
Contact person for scientific queries
Name 147460 0
Anwar Hassan
Address 147460 0
Physiotherapy Department, Nepean Hospital, Nepean Blue Mountains LHD PO Box 63, Penrith, NSW, 2751
Country 147460 0
Australia
Phone 147460 0
+61 2 4734 2140
Fax 147460 0
Email 147460 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Must seek approval from Research Governance Office at Nepean Blue Mountains Local Health District first.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Appendix 1 - PCIF CTIQ DigiOnboardingV2.0_Clean.docx


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.