ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625001354471

Ethics application status

Approved

Date submitted

18/02/2025

Date registered

3/12/2025

Date last updated

3/12/2025

Date data sharing statement initially provided

3/12/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Wearable-Enhanced Care to Assist stress Regulation and Empowerment in emergency care settings (The WeCare Study).

Scientific title

Optimising stress regulation and resilience with wearable devices in emergency care settings: a single-case experimental study with replication.

Additional trial identifiers [1]

N/A

Universal Trial Number (UTN)

U1111-1318-9082

Trial acronym

The WeCare Study

Related trial records

Health condition

Health condition(s) studied:

Psycho-physiological distress in emergency department patients and healthcare professionals.

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is a 6-week wearable-based stress regulation and resilience program (WeCare program), using a smart ring to track real-time biometric information, including heart rate, sleep and stress patterns, and breathing activity. The program guides individuals through a personalised, stepped process of self-awareness and lifestyle behaviour changes, including an initial education session, weekly telephone check-ins, and optional activities aimed at enhancing stress management and resilience via the smartphone app. Participants use the app to access real-time biometric insights, track progress with activity logbooks, and engage in self-reflection journaling, while weekly email updates provide insights and recommendations to encourage lifestyle modifications. Self-regulation techniques, such as breathwork and meditation, are also available through the app.

The initial education session introduces participants to the multidimensional nature of stress and wellbeing, including its physiological manifestations. Participants are introduced to the smart ring, instructed on installation of the app, and begin continuous data and daily activity tracking. They also receive an overview of the WeCare program and guidance on how to use the smart ring and app effectively, with the goal of building foundational awareness and context-specific understanding of stress and wellbeing. This session is conducted by a research assistant or research fellow with a psychology and/or medical background.

Weekly telephone check-ins are conducted by the same research assistant/research fellow and are designed to monitor progress, address participant questions, and provide personalised support. Participants may choose to share their biometric data from the smart ring in advance to guide the discussion and tailor feedback, supporting engagement with the program and encouraging lifestyle modifications. Participants are also encouraged to explore optional self-regulation strategies through the app, such as breathwork and mindfulness modules, and integrate healthy habits and reflection practices into their daily routines.

Participants are asked to check the app at least upon waking each day to review their health metrics and on some days in the evening or during the day to complete reflection activities. Engagement beyond these minimum touchpoints is encouraged but not mandated, allowing flexibility to explore additional features as suited to individual routines. Biometric data can be viewed directly through the app linked to the smart ring. Adherence and engagement are monitored via smart ring wear time, app usage analytics from the digital health platform, and participant feedback, which inform assessment of program fidelity and adherence to intervention components.

Following the main 6-week program, participants can opt for a 2-week extension phase to experience the intervention delivered via a smartwatch instead of a smart ring, providing an alternative delivery method. This phase is an integral part of the “acceptability” evaluation conducted during the co-design component and is not intended to test effectiveness. Therefore, there are no weekly telephone check-ins or specific optional activities for this period. Participants will, however, have access to in-built breathwork and mindfulness modules within the smartwatch to support stress management and resilience.
There are some differences in device use between the smart ring and the smartwatch. Participants using the smart ring can view their biometric data (e.g., sleep, heart rate, recovery indicators) through the associated smartphone app, which also integrates reflection and wellbeing tracking features. In contrast, participants using the smartwatch can view basic real-time metrics (e.g., heart rate, activity) directly on the device, with more detailed summaries accessible via the paired smartphone app.

Intervention code [1]

Treatment: Devices

Description of the comparator or control

The study employs an N-of-1, single-case, randomised, concurrent multiple-baseline design with replications. This method consists of a series of single-case experiments, with at least three tiers, where each participant acts as their own control. In this design, the baseline phase serves as the control period and begins simultaneously for all participants. During this phase, participants continue their usual care with no imposed restrictions on lifestyle or activities. Usual care may include self-care or stress management practices such as exercise, mindfulness, counselling, or peer support. The baseline duration varies from a minimum of 1 weeks to a maximum of 3 weeks, ensuring at least five primary outcome observations per participant to maintain methodological rigor. To meet single-case study design standards, participants are assigned to one of three baseline tiers: (i) Tier I: ~7 days (week 1); (ii) Tier II: ~11 days (week 2); or (iii) Tier III: ~15 days (week 3).

The intervention is introduced at different time points across these tiers, ensuring a rigorous multiple-baseline structure. The staggered intervention allows participants in the baseline phase to act as controls, preventing any expected improvements before the intervention begins. By varying baseline lengths across tiers, the design minimises the risk of external events influencing transition data, enhancing internal validity.

Control group

Active

Outcomes

Primary outcome [1]

Psychological distress

Timepoint [1]

Every 24 hours (daily diary) for up to 12 weeks, Every 2 hours during waking period (ecological assessment) for up to 4 days (2 during baseline, 2 during intervention), At 3- and 6-month post-intervention (follow-ups).

Primary outcome [2]

Sleep quality

Timepoint [2]

Every 24 hours (daily diary) for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [1]

Heart Rate Variability (HRV) metrics - Root mean square of successive differences (RMSSD) - Primary outcome.

Timepoint [1]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [2]

HRV metrics - Heart rate - Primary outcome.

Timepoint [2]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [3]

HRV metrics - Low frequency - Primary outcome.

Timepoint [3]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [4]

HRV metrics -High frequency - Primary outcome.

Timepoint [4]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [5]

HRV metrics - Total power - Primary outcome.

Timepoint [5]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [6]

HRV metrics - Low and High frequency ratio (LF/HF) - Primary outcome.

Timepoint [6]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [7]

HRV metrics- Standard deviation of all normal RR intervals (SDNN) - Primary outcome.

Timepoint [7]

Daily average monitoring and resting average during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [8]

Sleep metrics - Total sleep length - Primary outcome.

Timepoint [8]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [9]

Sleep metrics - Light sleep duration - Primary outcome.

Timepoint [9]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [10]

Sleep metrics - Rapid eye movement (REM) duration - Primary outcome.

Timepoint [10]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [11]

Sleep metrics - Deep sleep duration - Primary outcome.

Timepoint [11]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [12]

Sleep metrics - Awake time - Primary outcome.

Timepoint [12]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [13]

Sleep metrics - Sleep latency - Primary outcome.

Timepoint [13]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [14]

Sleep Daily Score Summary

Timepoint [14]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [15]

Readiness Daily Score Summary

Timepoint [15]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [16]

Stress Daily Score Summary

Timepoint [16]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [17]

Step count

Timepoint [17]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [18]

Respiration rate

Timepoint [18]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [19]

Oxygen saturation level

Timepoint [19]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [20]

Body temperature

Timepoint [20]

Daily average and temperature deviation during sleep for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [21]

Global life stress

Timepoint [21]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [22]

Depressive mood

Timepoint [22]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [23]

Post-traumatic stress disorder symptoms

Timepoint [23]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [24]

Anxiety

Timepoint [24]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [25]

Sleep

Timepoint [25]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [26]

Adverse events (e.g., temporary skin irritation from wearing the device, or mild discomfort/ fatigue associated with increased self-monitoring or engagement with app-based exercises) - used to assess feasibility (safety)

Timepoint [26]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [27]

Consumer perception

Timepoint [27]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [28]

Quality of life

Timepoint [28]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [29]

Mental wellbeing

Timepoint [29]

Before intervention commencement, at the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [30]

Cognitive functioning

Timepoint [30]

Before intervention commencement, at the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [31]

Pain interference

Timepoint [31]

Before intervention commencement, at the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [32]

Fatigue

Timepoint [32]

Before intervention commencement, at the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [33]

Social participation

Timepoint [33]

Before intervention commencement, at the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [34]

Consumer’s satisfaction

Timepoint [34]

At the end of intervention (within 2 weeks)

Secondary outcome [35]

Continuation of use

Timepoint [35]

At the end of intervention (within 2 weeks), and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [36]

Adherence/time wearing device - used to assess feasibility (adherence)

Timepoint [36]

Daily average monitoring for up to 12 weeks, and optionally up to 6 months (if the smart ring is used beyond the intervention).

Secondary outcome [37]

Life stressors (e.g., interpersonal conflict, financial strain, health concerns)

Timepoint [37]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [38]

Self-reported direct and indirect costs for economic evaluation (e.g., healthcare utilisation, time off work)

Timepoint [38]

Weekly for up to 12 weeks, and at 3- and 6-month post-intervention (follow-ups).

Secondary outcome [39]

Participants’ perceptions of the acceptability and usability of the program across domains such as affective attitude, burden, ethicality, coherence, opportunity costs, perceived effectiveness, and self-efficacy

Timepoint [39]

Assessed once post-intervention (occurring within 2 weeks of the final intervention session)

Secondary outcome [40]

Participant's engagement with the program and program fidelity - used to assess feasibility (engagement)

Timepoint [40]

Weekly for up to 12 weeks

Eligibility

Key inclusion criteria

The study include four samples of participants, comprising individuals exposed to severe stress in emergency care settings. This involves 3-8 eligible participants per sample (at least 3 participants per experiment), resulting in a total of up to 32 participants. These samples include:
(1) Sample 1: those seeking emergency care for mild-to-moderate acute injuries;
(2) Sample 2: those seeking emergency care for severe acute injuries;
(3) Sample 3: those seeking emergency care for mild-to-moderate acute medical complaints; and
(4) Sample 4: healthcare professionals working in Emergency care settings.

Participants will be included if:
All participants
• Aged 18-70 years
• Sufficient English proficiency
• Willing to wear a smart watch and/or a smart ring device for at least 22 hours for the next 3 months

Sample 1: Mild-to moderate injured participants
• Sustained in last 2 weeks, a minor-to-moderate traumatic injury due to non-violent cause (e.g., traffic crash, fall, work-related), such as a whiplash injury, minor fractures, limb fractures, joint sprains or strains.
• Presented to RNSH emergency department (ED), Sydney, Australia
• Injury Severity Score less than 15

Sample 2: Severe injured participants
• Sustained in last 4 weeks, a severe traumatic injury due to non-violent cause (e.g., traffic crash, fall, work-related), such as multi-trauma or severe injuries requiring aggressive therapy and/or admission to Intensive Care Unit (ICU)
• Presented to RNSH emergency department, Sydney, Australia
• Injury Severity Score greater than or equal to 15

Sample 3: Medical participants
• Acute onset of medical symptoms of minor-to-moderate severity, such as musculoskeletal symptoms (e.g., back pain, neck pain), gastrointestinal symptoms (e.g., abdominal pain, nausea), urinary symptoms (e.g., urinary tract infections); respiratory symptoms (e.g., mild shortness of breath, persistent cough) or migraine, prompting a visit to the Emergency Department (ED) for evaluation and care.
• Presented to RNSH emergency department (ED), Sydney, Australia.
• Received an Australasian Triage Scale (ATS) category 3–5= less urgent, requiring standard treatment home or inpatient non-ICU.

Sample 4: ED health workers participants
• Being a healthcare worker at the Emergency Department of Royal North Shore Hospital (RNSH), Sydney, Australia, including including clinical and non-clinical staff

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

Participants will be excluded if:
All participants
• History or evidence of substance abuse (e.g., alcohol, illicit drugs) at the time of admission.
• History of severe mental health disorders, e.g. bipolar disorder or psychoses or chronic depression disorder, determined by medical history or psychiatric interview.
• History of unstable or poorly controlled cardiovascular, neurological, or other serious systemic disease that is likely to interfere with study evaluation or participant safety (e.g., uncontrolled blood pressure, unstable arrhythmia, decompensated heart failure, recent myocardial infarction or stroke, new or uncontrolled metabolic or inflammatory conditions).
• Evidence of any conditions (e.g., cognitive disorder, dementia) that interfere with the patient’s ability to understand the requirements of the study and their ability to consent
• Taking cardioactive medication (e.g., antihypertensive, antidepressants, antipsychotics, antihistamines, ß-agonists) that affects cardiovascular system and study outcome (e.g., HRV)
• Undergoing, or planning to undergo, surgery or inpatient admission/ hospitalisation during the next three months.

Sample 1: Mild-to moderate injured participants
• Injuries due to violent causes, such as assaults or self-arm
• Injuries involving the brain
• Very minor, localised, superficial soft-tissue injuries, such as small cuts, abrasions, minor bruises, or localised swelling

Sample 2: Severe injured participants
• Injuries due to violent causes, such as assaults or self-harm
• Injuries involving the brain
• Catastrophic injuries as defined by NSW lifetime care, that is, a very severe traumatic brain injury, a spinal cord injury, extensive burns to the body (>60%), major amputation or blindness

Sample 3: Medical participants
• Requiring aggressive or palliative treatment, intubation or ICU admission.

Sample 4: ED healthcare workers participants
• History of injury requiring ED presentation or exposure to a traumatic event (i.e., perceived threat of injury to self or others) in the past year.
• Presented to the ED or admitted to hospital in the past year.

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)

A computer-generated random allocation schedule will be formulated prior to the starting of the study by an independent person who is not involved in recruitment. The allocation sequence will be uploaded to a web-based software (e.g., REDCap) system with limited access. After the participant passes the screening process and completes the pre-baseline assessment, allocation will be revealed. The participant will be considered to have enrolled in the study at this point.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation sequence will be generated on excel spreadsheet using a “rand” function and then be uploaded on an online web-based software (e.g., REDcap) by one of the researchers not involved in treatment and assessment.

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

A series of N-of-1 study using a multiple baseline design, nested within a multiple baselines approach. Replication is essential in single-case experimental designs to establish causality and assess the generality of intervention effects, strengthening both internal and external validity. This study includes four participant groups to enable both direct and systematic replication, ensuring the intervention’s reliability and generalisability across diverse emergency care contexts. Direct replication (Sample 1: mild-to-moderate injuries) confirms the intervention’s effectiveness within a comparable injury population. Systematic replication extends its applicability by testing it in three additional groups: individuals with more severe injuries (Sample 2) to assess efficacy across injury severities, non-injured patients experiencing acute medical symptoms (Sample 3) to explore its impact beyond physical trauma, and ED staff/shift workers (Sample 4) to evaluate its relevance for occupational stress. This approach provides a comprehensive understanding of the intervention’s effects across different stressors and populations within high-stress emergency care settings.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

For the primary measures, graphical representation and calculation of a mean and trend line will be used to analyse changes over time and between periods. Level- and slope-change analyses will be used to further analyse change between periods. Secondary analyses will be performed on secondary outcomes. No interim analyses will be performed in this study. Level of significance to be used will be set at 0.05 unless otherwise required. Quality of the dataset will be inspected regularly by outcome assessors for missing data. Additionally, missing, or spurious data will also be inspected by one of the senior researchers. Moreover, linear mixed-effects modelling (LMEM), a multiple regression technique that is flexible and suitable for single-case design studies, will be used to provide standardised effect sizes and measures of statistical significance. A feasibility analysis will be also conducted using prespecified progression criteria to help guide the interpretation of pilot trial findings to decide whether, and how, a definitive RCT is feasible and should be conducted.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/01/2026

Actual

Date of last participant enrolment

Anticipated

30/06/2027

Actual

Date of last data collection

Anticipated

31/12/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Northern Sydney Local Health District

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Kolling Institute L13, 10 Westbourne St, Royal North Shore Hospital, St Leonards, NSW 2065.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/01/2025

Approval date [1]

27/03/2025

Ethics approval number [1]

2025/ETH00118

Summary

Brief summary

Emergency care settings are high-stress environments that affect both patients and healthcare workers, with acute stress responses influencing recovery, morbidity, and long-term mental health. If unmanaged, physiological stress reactions can escalate into chronic conditions such as PTSD, depression, and anxiety. This study evaluates the WeCare program, a wearable-integrated stress management intervention that provides real-time physiological feedback to enhance self-regulation and resilience. Using a single-case experimental design, the WeCare program will be tested for feasibility, effectiveness, and economic impact across four vulnerable groups: (i) mild-to-moderately injured patients, (ii) severely injured patients, (iii) individuals with acute medical symptoms, and (iv) emergency healthcare workers. Findings will inform scalable, early interventions to improve mental well-being and health outcomes in emergency care settings.

Trial website

N/A

Trial related presentations / publications

Public notes

Due to form limitations allowing a maximum of 40 outcomes, pre-baseline measures, collected once at enrolment to establish the baseline profile of each participant, are not listed here. These include: the Psychosocial Index, The Pain Catastrophising scale, the Injustice Experience Questionnaire, the General self-efficacy scale, the Composite Scale of Morningness , Brief Resilience Scale, and EQ-5D prior overall health status.

Contacts

Principal investigator

Name

Dr Ilaria Pozzato

Address

John Walsh Centre for Rehabilitationn Research, Level 12 The Kolling Institute, 10 Westbourne Street, StLeonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4772

Fax

[email protected]

Contact person for public queries

Name

Ilaria Pozzato

Address

John Walsh Centre for Rehabilitationn Research, Level 12 The Kolling Institute, 10 Westbourne Street, StLeonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4772

Fax

[email protected]

Contact person for scientific queries

Name

Ilaria Pozzato

Address

John Walsh Centre for Rehabilitationn Research, Level 12 The Kolling Institute, 10 Westbourne Street, StLeonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4772

Fax

[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 a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• Primary outcome(s)

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Repository of journals where the results of the study will be published and can be accessed subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically