Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001043426p
Ethics application status
Submitted, not yet approved
Date submitted
18/08/2025
Date registered
22/09/2025
Date last updated
22/09/2025
Date data sharing statement initially provided
22/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
SMS Text Message Support for Motor Vehicle Related Injury
Scientific title
Evaluating the Effect of an SMS Text Message Information and Support Program on Pain Self-Efficacy in People Who Have Experienced a Motor Vehicle Related Injury.
Secondary ID [1] 315158 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road traffic related injury 338589 0
Condition category
Condition code
Injuries and Accidents 334888 334888 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive two short video resources and a program of supportive text messages, in addition to usual customer support. On Day 0, participants will be sent a video (via SMS link) providing targeted information about the Allianz claims process, co-designed with former claimants and Allianz claims staff (approx 6 minutes). On Day 1, participants will receive a second video (via SMS link) containing brief, evidence-based pain self-management education (approx. 5 minutes), including strategies such as relaxation techniques, thought management, distraction, and seeking social support.
From Day 2 onwards, participants will receive one supportive text message per day for 28 consecutive days. These messages are brief (160–320 characters), written in simple language, and are designed to reinforce the information provided in the videos, encourage proactive engagement with the claims process, remind participants of behavioural pain self-management strategies, and provide reassurance, validation, and encouragement during recovery.
Messages are standardised by day, personalised with participants’ first names in some cases, and delivered at no cost to participants between 9 AM and 5 PM (local time). Adherence to the intervention (watching the videos, reading text messages) will be self-reported by participants in a survey at the end of the trial.
Intervention code [1] 331777 0
Behaviour
Comparator / control treatment
Participants will receive usual customer support plus the same two videos provided to the intervention group, but no supportive text messages. Specifically, on Day 0 they will be sent (via SMS link) the co-designed Allianz claims information video, and on Day 1 they will be sent (via SMS link) the brief (~5-minute) pain self-management video. From Day 2 onward, participants in the control group will not receive the 28-day program of daily supportive SMS messages. This comparator controls for exposure to core information while isolating the effect of ongoing text messaging.
Control group
Active

Outcomes
Primary outcome [1] 342512 0
Pain Self-Efficacy
Timepoint [1] 342512 0
Day 0 (Enrolment and first text message with video sent), Day 30 (30 days post enrolment and the day of last SMS message for intervention group) and 4 months (4 months post-enrolment)
Secondary outcome [1] 451116 0
Pain, Enjoyment of life and General activity will be assessed as a composite outcome using the PEG Pain Screening Tool
Timepoint [1] 451116 0
Day 0, Day 30 and four months post-enrolment
Secondary outcome [2] 451117 0
Anxiety and depression - this will be assessed as a composite outcome via Patient Health Questionnaire-4 (PHQ-4)
Timepoint [2] 451117 0
Day 0, day 30 and four months post-enrolment
Secondary outcome [3] 451118 0
Claims satisfaction
Timepoint [3] 451118 0
Day 30 post-enrolment
Secondary outcome [4] 451119 0
Healthcare costs
Timepoint [4] 451119 0
4 months post-enrolment
Secondary outcome [5] 451120 0
Adoption, engagement and reach will be assessed as a composite outcome via questionnaire
Timepoint [5] 451120 0
Day 30 post-enrolment
Secondary outcome [6] 451121 0
Concerns about pain
Timepoint [6] 451121 0
Day 0, 30 days and 4 months post-enrolment
Secondary outcome [7] 451123 0
Acceptability and Feasibility will be measured as a composite outcome
Timepoint [7] 451123 0
Day 30 post enrolment
Secondary outcome [8] 451701 0
Return to Work status
Timepoint [8] 451701 0
4 months post enrolment

Eligibility
Key inclusion criteria
Inclusion:
- Lodged Compulsory Third Party (CTP) claim with Allianz
- Owns smartphone and can receive SMS
- Able to read English or supported by a translator
- Willing to complete digital surveys
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cognitive impairment or language limitations preventing survey completion
- Inability to engage with digital content due to medical/mental health status

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
Primary outcome: Between-group difference in pain self-efficacy at 30 days using independent samples t-test or ANCOVA if there was imbalance at baseline.
Secondary outcomes: Claims satisfaction, anxiety and depression, concerns about pain, pain, healthcare costs and return to work. Analysed using t-tests or Mann-Whitney U tests for continuous variables and chi-square or Fisher’s exact tests for categorical outcomes.
Missing data: Intention-to-treat and per-protocol analyses will be conducted. Multiple imputation will be considered for missing data.
Statistical software: SPSS v29
We will run an interim analysis at 25% of the estimated sample size to re-estimate the sample size based on the variance and dropout rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
254
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319734 0
Commercial sector/Industry
Name [1] 319734 0
Allianz Insurance
Country [1] 319734 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322241 0
None
Name [1] 322241 0
Address [1] 322241 0
Country [1] 322241 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318284 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 318284 0
Ethics committee country [1] 318284 0
Australia
Date submitted for ethics approval [1] 318284 0
08/08/2025
Approval date [1] 318284 0
Ethics approval number [1] 318284 0

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

Contacts
Principal investigator
Name 143702 0
A/Prof Claire Ashton-James
Address 143702 0
Ground floor, Douglas Building Royal North Shore Hospital, St. Leonards 2065, NSW, Australia
Country 143702 0
Australia
Phone 143702 0
+61 410365816
Fax 143702 0
Email 143702 0
[email protected]
Contact person for public queries
Name 143703 0
Alison Sim
Address 143703 0
Ground floor, Douglas Building Royal North Shore Hospital, St. Leonards 2065, NSW, Australia
Country 143703 0
Australia
Phone 143703 0
+61 2 9463 1528
Fax 143703 0
Email 143703 0
[email protected]
Contact person for scientific queries
Name 143704 0
Alison Sim
Address 143704 0
Ground floor, Douglas Building Royal North Shore Hospital, St. Leonards 2065, NSW, Australia
Country 143704 0
Australia
Phone 143704 0
+61 2 9463 1528
Fax 143704 0
Email 143704 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 review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• 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:
• Published results
• Primary outcome(s)
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
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.