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

NCT ID: NCT06977464

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-09

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Injury Return to Work Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Wearable Technology and Information Software-Based Psychological Stress Monitoring

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

Group Type ACTIVE_COMPARATOR

Wearable Technology and Information Software-Based Psychological Stress Monitoring

Intervention Type DEVICE

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

Control

All participants will receive standard outpatient care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wearable Technology and Information Software-Based Psychological Stress Monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202503083RIND

Identifier Type: -

Identifier Source: org_study_id

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