RISE (Recovery, Information, Support and Empowerment): Feasibility of a clinician-supported SMS intervention for individuals at risk of poor recovery after acute whiplash injury

INTERVENTION: 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. Information CONDITION: Acute whiplash associated disorder;Pain intensity;Psychological distress; ; Acute whiplash associated disorder ; Pain intensity ; Psychological distress Injuries and Accidents ‐ Other injuries and accidents Mental Health ‐ Other mental health disorders Musculoskeletal ‐ Other muscular and skeletal disorders SECONDARY OUTCOME: 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. [Purpose built items to assess the effectiveness of RISE intervention domains, Session Rating Scale administered at the end of the clinician sessions (where applicable), observation of the number of participants who use the ‘snooze’ or ‘stop’ functions, on‐demand messages, and weekly diaries, and participant feedback on message frequency and perceived helpfulness, and he extent of valid data derived from the wearable device. ; ; Multiple methods will be used to collect this data: Snooze/stop functions will be assessed from message analytics, weekly self‐report participant diaries used to assess helpfulness, self‐report items will be used to assess the clinician sessions, two‐way message responses from study records, and data completeness from the wearable devices (once downloaded). Baseline, end of clinician session (where applicable, anytime during the 3‐week intervention), 6 weeks post‐randomisation, and 3 months post‐randomisation.] Depression, anxiety, and stress symptoms[Depression, anxiety, and stress symptoms will be measured at baseline and at all follow ups using the 21‐item Depression Anxiety and Stress Scale (DASS‐21). Participants will be asked to read each statement and indicate how much the statement has applied to them over the past week, from “0 – Did not apply to me” to “3 – Applied to me very much or most of the time.” Example statements include, “I found it hard to wind down”. Baseline, 6 weeks post‐randomisation, and 3 months post randomisation.] Energy expenditure (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] Feasibility of collecting cost data to inform a future economic evaluation. [Participants will be asked to retrospectively report their daily health service use including medical (including radiology/imaging), allied health, and complementary (e.g., massage, acupuncture) care appointments and medication use including over the counter medication (type, dose, frequency) for management of WAD over the preceding two weeks. Participants will also be asked to report their current and prior to the injury work status, gross yearly salary range and percentage of regular work capacity, insurance claim status, any legal involvement, and any finalised claim payout amounts. Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation. ] Health‐related quality of life.[Health‐related quality of life will be assessed using the EQ‐5D‐5L(39). The EQ‐5D‐5L measures current health status across five domains: mobility, self‐care, usual activities, pain/discomfort, and anxiety/depression. For each domain, participants select one of five response options indicating severity of problems, ranging from “no problems” to “extreme problems”. Participants then rate their overall health “today” on a scale from 0 (“the worst health you can imagine”) to 100 (“the best health you can imagine”). Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation. ] Heart Rate Variability (HRV) (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] Neck pain related disability[Neck Disability Inde X(NDI); total score (0–50), higher scores indicate greater disability. Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation. ] Pain intensity level ; [Brief Pain Inventory sub scale Baseline, 6 weeks post‐randomisation and 3 months post‐randomisation.] Patient overall improvement (global impression of change) ; [Global Impression of Change (GIC). Participants are asked to evaluate how their overall condition and specific functional domains have changed since commencing treatment, relative to pre‐treatment. Domains assessed include overall functioning, physical activities, social activities, work‐related activities (including household work), mood, and pain. Each item is rated on a 7‐point Likert scale ranging from “Very much improved” to “Very much worse.” 6 weeks post randomisation and 3 months post‐randomisation.] Post‐traumatic stress symptoms ‐ Screen[Post‐traumatic stress symptoms will be assessed using the Primary Care PTSD Screen for DSM‐5 (PC‐PTSD‐5). The PC‐PTSD‐5 is a 5‐item screening measure assessing core PTSD symptom domains experienced over the past month. Participants respond “Yes” or “No” to items assessing re‐experiencing (e.g., unwanted memories or nightmares), avoidance of trauma‐related thoughts or reminders, hyperarousal (e.g., being on guard or easily startled), emotional numbing or detachment, and trauma‐related guilt or self‐blame. Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation. ] Post‐traumatic stress symptoms[Participants scoring 3 or more on the PC‐PTSD‐5 will subsequently complete the PTSD Checklist for DSM‐5 to assess the severity of PTSD symptoms. The PCL‐5 (37) is a 20‐item self‐report measure assessing DSM‐5 PTSD symptom clusters over the past month, with higher scores indicating greater symptom severity. Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation (if participants screen positive on the PC‐PTSD‐5).] Psychological distress[The K6 is a 6‐item measure of non‐specific psychological distress used to determine presence of acute psychological distress that would preclude their involvement in the study and will be repeated at follow up time points. Items are measured on a 5‐point Likert scale, ranging from 1 (“All of the time”) to 5 (“None of the time”) and ask participants to indicate how they have been feeling during the past 30 days (e.g. how… nervous, hopeless, restless/fidgety, worthless, that everything was an effort). Eligibility screening (pre‐baseline), 6 weeks post‐randomisation, and 3 months post‐randomisation.] Respiration rate (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] Sleep data (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] Step count (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] Stress score (RISE participants only)[A smartwatch (Garmin or Empatica) 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. ] 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. PRIMARY OUTCOME: Feasibility of the intervention in practice including recruitment rates, intervention uptake and acceptability, and retention. This will be assessed as a composite outcome.[Feasibility will be evaluated, including: ; ‐ Recruitment (percentage of eligible participants who consent to participate; average number of participants recruited per month; and percentage who consent to use the wearable device (RISE intervention group only)); ; ‐ Retention (percentage completing the 6‐week post‐intervention and 3‐month follow‐up assessments and % who complete the cost diary at baseline, 6 weeks and 3 months)); ; ‐ RISE Intervention uptake (percentage of RISE participants responding to 3 or more interactive SMSs during the intervention period; and percentage of scheduled psychologist and/or physiotherapist sessions that are attended); ; ‐ Acceptability (Technology Acceptance Model usefulness and ease‐of‐use subscale mean scores of 4 or more out of 5) as reported on the self‐report questionnaires.; ; Recruitment rates will be determined from study logs, retention determined from text message analytics, and sessions attended determined from session attendance logs. ; ; These will be summarised descriptively and interpreted against pre‐defined traffic‐light progression criteria and data from the process evaluation. Baseline, 6 weeks post‐randomisation, and 3 months post‐randomisation (and throughout as required from study/attendance logs) ]