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

NCT06977464 | Enrolling By Invitation

• 1 other identifier: 202503083RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury; Return to Work; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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.

Device: Wearable Technology and Information Software-Based Psychological Stress Monitoring

Control

NO INTERVENTION

All participants will receive standard outpatient care.

Interventions

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.

Wearable Technology and Information Software-Based Psychological Stress Monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10093, Taiwan

Location

MeSH Terms

Conditions

Wounds and Injuries; Psychological Well-Being

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

TW (1)