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Enrolling by Invitation

NCT Number: 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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 10093

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearable Technology and Information Software-Based Psychological Stress Monitoring

Device

The intervention group will additionally use a smartwatch for physiological monitoring and a mobile app for daily to weekly psychological assessments.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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