Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000506392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/03/2026
Date registered
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23/04/2026
Date last updated
Help: Date last updated
23/04/2026
Date data sharing statement initially provided
Help: Data sharing statement date
23/04/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
RISE (Recovery, Information, Support and Empowerment): Feasibility of a clinician-supported SMS intervention for individuals at risk of poor recovery after acute whiplash injury
Scientific title
Protocol for a Randomised Feasibility Trial of a Clinician-Supported SMS-based Behavioural Intervention to Support Recovery after Acute Whiplash Injury
Additional trial identifiers [1] 316670 0
NIl
Universal Trial Number (UTN)
Trial acronym
RISE (Recovery, Information, Support and Empowerment)
Related trial records

Health condition
Health condition(s) studied:
Acute whiplash associated disorder 340912 0
Pain intensity 340913 0
Psychological distress 340914 0
Condition category
Condition code
Musculoskeletal 337064 337064 0 0
Other muscular and skeletal disorders
Injuries and Accidents 337065 337065 0 0
Other injuries and accidents
Mental Health 337066 337066 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
RISE SMS intervention

RISE is a clinician-supported, tailored text message–based intervention designed to support recovery in people with acute whiplash-associated disorder following a road traffic crash. The intervention is delivered over approximately 3 weeks + optional 3 days.

All text scheduling and storage (in both treatment and comparator conditions) occurs within The University of Queensland’s research infrastructure; text messages (both sent and received) will briefly held on CellCast’s infrastructure using a dedicated study telephone number.

Onboarding phase (7 days):
Participants receive welcome text messages (approximately 3 separate messages due to text limits) and are then contacted by telephone to nominate their preferred message delivery times and, where applicable, arrange delivery of a wearable device (Garmin or Empatica EmbracePlus). Participants will also have the option to receive two 30-minute clinician support sessions (telephone or email) with a psychologist and physiotherapist if they wish; this session will be delivered at the participant's preferred time anytime during the 3-week intervention period. Participants will then receive onboarding messages ( (approximately 5 separate messages due to text limits) to inform them about the intervention process, two-way messaging and other features.

RISE text message delivery (3 weeks, with optional 3-day extension):
Participants receive approximately one text message per day for 3 weeks. Messages are written in simple language and target stress symptom management and pain coping. Content is based on prior co-design work and organised into four RISE domains:
1. Recovery focused messages that provide reassurance, encouragement, and emotion support.
2. Informational support providing education on whiplash injury and pain, and what to expect during recovery.
3. Support targeted to foster behaviour change, including cognitive-behavioural psychological techniques.
4. Empowering and motivational messages to enhance patient confidence in managing their pain and recovery.

Participants may opt to receive additional messages for a further 3 days; they will be notified of this option at the end of week 3.

All participants receive access via text message link to evidence-based advice and physiotherapy exercises on the My Whiplash Navigator website (https://mywhiplash.com.au/node/77).

The exercises include:
Range of motion/movement
Front of neck (neck flexors)
Back of neck (neck extensors)
Shoulder area (shoulder girdle).
Neck and shoulder exercises are grouped into beginner, intermediate and advanced exercises, indicated by the different icons.

RISE intervention personalisation
The intervention includes features to tailor message content and delivery over the intervention period. These include the following.
Preferred message timing: Participants nominate their preferred time of message delivery during onboarding.
Optional clinician sessions: Participants may receive one 30-minute session with a psychologist and one 30-minute session with a physiotherapist during the intervention period. This is discussed during onboarding and scheduled if requested.
On-demand messages: Participants can request messages at any time by texting a keyword (e.g., CALM, ACTIVATE).
Message frequency options: At the end of week 1, participants receive a prompt to review message frequency and may choose to reduce frequency for a 24-hour period. Participants can also reduce message frequency at any time by texting SNOOZE.
Baseline-triggered messages: Messages are delivered during weeks 1–3 based on baseline survey responses (e.g., sleep disturbance, concentration difficulties).
Two-way SMS check-ins: During weeks 1–3, participants receive two-way messages to rate pain, stress, and perceived support.
Weekly diary: Participants are invited to complete a weekly diary to reflect on their experiences.
Short extension option: At the end of week 3, participants may choose to receive messages for an additional 3 days.

Clinician support session/s:
Participants may opt to receive up to two optional clinician support sessions during the intervention period: one 30-minute session with a psychologist and one 30-minute session with a physiotherapist. Uptake of these sessions is at the participant’s discretion. The psychologist session focuses on reviewing progress, providing psychological support, and assisting with goal setting. The physiotherapist session focuses on activity and exercise education, advice, and goal setting.

Responses to two-way messages will be monitored and will be used to assess intervention engagement.

Participants who received a smart watch as part of the study will return them via post once they have completed the 3-week intervention.


Intervention code [1] 333349 0
Treatment: Other
Intervention code [2] 333350 0
Behaviour
Intervention code [3] 333351 0
Prevention
Description of the comparator or control
Active control: general health-related text messages + access to My Whiplash Navigator online resource

Participants allocated to the active control group will receive two general health-related text messages over 3 weeks and prompted access to the My Whiplash Navigator online resource.

Onboarding phase (7 days):
Participants will receive welcome and introductory text messages equivalent in timing and format to those provided to the intervention group. They will not be contacted to nominate preferred message delivery times, and no wearable device or clinician support sessions will be offered.

Text message delivery (3 weeks):
Participants will receive approximately two text messages per week. Messages will provide general health information relevant to recovery after whiplash injury. Participants will also receive a text message link to the publicly available My Whiplash Navigator website, which provides evidence-based advice and physiotherapy exercises for whiplash-associated disorders. Messages will not be tailored and will not include behaviour change strategies, psychological techniques, interactive check-ins, or on-demand keyword functionality. An example text message includes: "Keeping active is important when recovering from a whiplash injury."

Level of support:
No clinician support session, personalisation features, interactive SMS monitoring, or tailored messaging will be provided.
Control group
Active

Outcomes
Primary outcome [1] 344582 0
Feasibility of the intervention in practice including recruitment rates, intervention uptake and acceptability, and retention. This will be assessed as a composite outcome.
Timepoint [1] 344582 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation (and throughout as required from study/attendance logs)
Secondary outcome [1] 458457 0
Pain intensity level
Timepoint [1] 458457 0
Baseline, 6 weeks post-randomisation and 3 months post-randomisation.
Secondary outcome [2] 458459 0
Additional indicators of acceptability will assessed as a composite outcome, and includes intention to use (or continue using) the intervention, and the Session Rating Scale scores for participants who complete the clinician-guided session. In addition, behavioural indicators of acceptability and burden will be examined, as well as time wearing the devices including the extent of valid data derived from the wearable device.
Timepoint [2] 458459 0
Baseline, end of clinician session (where applicable, anytime during the 3-week intervention), 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [3] 458460 0
Patient overall improvement (global impression of change)
Timepoint [3] 458460 0
6 weeks post randomisation and 3 months post-randomisation.
Secondary outcome [4] 458461 0
Feasibility of collecting cost data to inform a future economic evaluation.
Timepoint [4] 458461 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [5] 458463 0
Health-related quality of life.
Timepoint [5] 458463 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [6] 458464 0
Post-traumatic stress symptoms - Screen
Timepoint [6] 458464 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [7] 458466 0
Neck pain related disability
Timepoint [7] 458466 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [8] 459138 0
Post-traumatic stress symptoms
Timepoint [8] 459138 0
Baseline, 6 weeks post-randomisation, and 3 months post-randomisation (if participants screen positive on the PC-PTSD-5).
Secondary outcome [9] 459139 0
Depression, anxiety, and stress symptoms
Timepoint [9] 459139 0
Baseline, 6 weeks post-randomisation, and 3 months post randomisation.
Secondary outcome [10] 459140 0
Psychological distress
Timepoint [10] 459140 0
Eligibility screening (pre-baseline), 6 weeks post-randomisation, and 3 months post-randomisation.
Secondary outcome [11] 459142 0
Heart Rate Variability (HRV) (RISE participants only)
Timepoint [11] 459142 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.
Secondary outcome [12] 460145 0
Sleep data (RISE participants only)
Timepoint [12] 460145 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.
Secondary outcome [13] 460146 0
Step count (RISE participants only)
Timepoint [13] 460146 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.
Secondary outcome [14] 460147 0
Respiration rate (RISE participants only)
Timepoint [14] 460147 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.
Secondary outcome [15] 460149 0
Energy expenditure (RISE participants only)
Timepoint [15] 460149 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.
Secondary outcome [16] 460151 0
Stress score (RISE participants only)
Timepoint [16] 460151 0
A smartwatch (Garmin or Empatica) worn by the participant will continuously record data from when received during the onboarding to over the 3-week intervention period; participants will be encouraged to wear it as much as possible everyday, except when needing to recharge the device.

Eligibility
Key inclusion criteria
Participants who are:
1) aged 18 years or older,
2) diagnosed with whiplash associated disorder (WAD) grade II/III (no fracture/dislocation) within 12 weeks of road traffic injury,
3) identified at risk of poor recovery on the WhipPredict risk screening tool and,
4) have access to a mobile phone and reasonable reception.

For individuals using the wearable device (RISE intervention only), a compatible smartphone for the App (Fitrockr or Care Lab App) will be required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Acute distress (K6 >13) and who are assessed as unable to participate
- Medical co-morbidity (e.g., Whiplash Associated Disorder Grade IV, fracture or injuries to other body areas, or recent spinal surgery in the past 12 months; or chronic pain condition that would potentially confound outcome measurement);
- Non-English speakers
- No mobile phone access

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 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 1:1 to either the intervention or active control group using a randomisation table generated by Research Randomiser (https://www.randomizer.org/) and uploaded to the REDCap.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Statistical methods / analysis
Participant characteristics and baseline measures will be summarised using descriptive statistics to assess the comparability of the intervention and control groups. As this is a feasibility trial, analyses will be primarily descriptive and will focus on estimating feasibility parameters. Feasibility outcomes (recruitment, retention, intervention engagement, wearable uptake, and data completeness) will be descriptively summarised. These estimates will be interpreted against the pre-defined progression criteria. No formal imputation of missing data is planned. The extent and patterns of missing data will be examined as part of the feasibility evaluation of the data collection procedures.

Preliminary changes on patient-reported outcomes will be explored using estimates of between-group differences with 95% confidence intervals at each follow-up time point. These analyses will be conducted on an intention-to-treat basis; however, the study is not powered to detect statistically significant differences, and no formal hypothesis testing will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2026
Actual
Date of last participant enrolment
Anticipated
1/05/2027
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 29207 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 29208 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 45516 0
4575 - Birtinya
Recruitment postcode(s) [2] 45517 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 45587 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 320418 0
Government body
Name [1] 320418 0
Motor Vehicle Accident Insurance Commission
Country [1] 320418 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 324003 0
None
Name [1] 324003 0
Address [1] 324003 0
Country [1] 324003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318966 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 318966 0
Ethics committee country [1] 318966 0
Australia
Date submitted for ethics approval [1] 318966 0
05/11/2025
Approval date [1] 318966 0
04/12/2025
Ethics approval number [1] 318966 0
HREC/2025/QTHS/121935

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

Contacts
Principal investigator
Name 145830 0
Dr Rachel Elphinston
Address 145830 0
Level 7, 288 Herston Rd, Herston, QLD 4029; RECOVER Injury Research Centre, The University of Queensland
Country 145830 0
Australia
Phone 145830 0
+61 7 3346 4763
Fax 145830 0
Email 145830 0
[email protected]
Contact person for public queries
Name 145831 0
Rachel Elphinston
Address 145831 0
Level 7, 288 Herston Rd, Herston, QLD 4029; RECOVER Injury Research Centre, The University of Queensland
Country 145831 0
Australia
Phone 145831 0
+61 7 3346 4763
Fax 145831 0
Email 145831 0
[email protected]
Contact person for scientific queries
Name 145832 0
Rachel Elphinston
Address 145832 0
Level 7, 288 Herston Rd, Herston, QLD 4029; RECOVER Injury Research Centre, The University of Queensland
Country 145832 0
Australia
Phone 145832 0
+61 7 3346 4763
Fax 145832 0
Email 145832 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.