Clinical trial NCT06977464: 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
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Injury
Return to Work
Mental Health
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Return to work
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: