InjuryNCT06977464
Application and Benefit Evaluation of Wearable Technology and Information Software-Based Psychological Stress Monitoring in Return-to-Work Healthcare for Injured Workers: A Longitudinal Study
A study testing Wearable Technology and Information Software-Based Psychological Stress Monitoring in people with Injury and Return to Work, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Objective This study aims to develop and evaluate a multidisciplinary service model that integrates wearable devices and mobile health applications to monitor the physical and mental health of workers with occupational injuries during their return-to-work process. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injury, Return to Work, Mental Health
- What is being tested?
- Wearable Technology and Information Software-Based Psychological Stress Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Injured workers aged 18 to 65 years.
- (2) Currently receiving follow-up care at the occupational medicine outpatient clinic of this hospital.
- (3) Expressed willingness to return to work.
- (4) Ability to access the internet and operate the mobile application using a smartphone.
Who cannot join
- (1) Individuals not expected to regain work capacity of at least 3 hours per day within six months.
- (2) Individuals who have resigned and do not intend to return to work within six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Objective This study aims to develop and evaluate a multidisciplinary service model that integrates wearable devices and mobile health applications to monitor the physical and mental health of workers with occupational injuries during their return-to-work process.
Background With advances in digital health, smartwatches and mobile applications are increasingly used in healthcare to support personalized monitoring and intervention. This project targets injured workers attending occupational medicine clinics, using smartwatches to monitor physiological data and a mobile application to assess psychological status. The model includes remote mental health support and aims to assess its impact on return-to-work outcomes and psychological well-being.
Read more
Methods A total of 120 eligible injured workers will be randomly assigned to an intervention or control group. All participants will receive standard outpatient care. The intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments. The 6-month follow-up will evaluate return-to-work success rate, time to return, post-return quality of life, and mental health status.
Intervention Tools The NTU Medical Genie, Labfront, and LINE@ platforms will facilitate real-time monitoring and batch downloading of smartwatch data, as well as the distribution of mood and stress-related questionnaires. At least three occupational rehabilitation education modules will be developed, and case managers will deliver individualized health education and psychological support.
Expected Outcomes The study will assess the effectiveness of this technology-supported, cross-disciplinary care model in improving return-to-work outcomes, mental health, and quality of life. It will also explore participant satisfaction and acceptance of the model. The findings are expected to inform future occupational health interventions and enhance care quality for injured workers.
- Conditions
- Injury, Return to Work, Mental Health
- Being tested
- Wearable Technology and Information Software-Based Psychological Stress Monitoring
- Medical subject headings
- Wounds and Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Technology and Information Software-Based Psychological Stress MonitoringDevice
The intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Technology and Information Software-Based Psychological Stress Monitoring | Active comparator | The intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments. Receives: Device: Wearable Technology and Information Software-Based Psychological Stress Monitoring |
| Control | No intervention | All participants will receive standard outpatient care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Successful return to work (defined as resumption of work with fewer than six weeks of subsequent sick leave) and the duration from initial clinic visit to return to work.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start9 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977464
- Sponsor's protocol ID
- 202503083RIND
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Benefit Evaluation of Wearable Technology and Information Software-Based Psychological Stress Monitoring in Return-to-Work Healthcare for Injured Workers: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT06977464
- Acronym / sponsor ID
- 202503083RIND
- Conditions
- Injury, Return to Work, Mental Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective This study aims to develop and evaluate a multidisciplinary service model that integrates wearable devices and mobile health applications to monitor the physical and mental health of workers with occupational injuries during their return-to-work process.
Background With advances in digital health, smartwatches and mobile applications are increasingly used in healthcare to support personalized monitoring and intervention. This project targets injured workers attending occupational medicine clinics, using smartwatches to monitor physiological data and a mobile application to assess psychological status. The model includes remote mental health support and aims to assess its impact on return-to-work outcomes and psychological well-being.
Methods A total of 120 eligible injured workers will be randomly assigned to an intervention or control group. All participants will receive standard outpatient care. The intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments. The 6-month follow-up will evaluate return-to-work success rate, time to return, post-return quality of life, and mental health status.
Intervention Tools The NTU Medical Genie, Labfront, and LINE@ platforms will facilitate real-time monitoring and batch downloading of smartwatch data, as well as the distribution of mood and stress-related questionnaires. At least three occupational rehabilitation education modules will be developed, and case managers will deliver individualized health education and psychological support.
Expected Outcomes The study will assess the effectiveness of this technology-supported, cross-disciplinary care model in improving return-to-work outcomes, mental health, and quality of life. It will also explore participant satisfaction and acceptance of the model. The findings are expected to inform future occupational health interventions and enhance care quality for injured workers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Technology and Information Software-Based Psychological Stress Monitoring | Active comparator | Device: Wearable Technology and Information Software-Based Psychological Stress MonitoringThe intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments. |
| Control | No intervention | –All participants will receive standard outpatient care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Injured workers aged 18 to 65 years.
- (2) Currently receiving follow-up care at the occupational medicine outpatient clinic of this hospital.
- (3) Expressed willingness to return to work.
- (4) Ability to access the internet and operate the mobile application using a smartphone.
Key exclusion criteria (2 listed)
- (1) Individuals not expected to regain work capacity of at least 3 hours per day within six months.
- (2) Individuals who have resigned and do not intend to return to work within six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Technology and Information Software-Based Psychological Stress MonitoringThe intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments. | Device | Wearable Technology and Information Software-Based Psychological Stress Monitoring |
Primary outcome
Return to work
Time frame: 6 months
Successful return to work (defined as resumption of work with fewer than six weeks of subsequent sick leave) and the duration from initial clinic visit to return to work.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Technology and Information Software-Based Psychological Stress Monitoring in people with Injury and Return to Work, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.