Skip to content

A randomised controlled trial complemented with biosignal diary data to evaluate a newly developed system for work-related stress management and prevention for older adults (mHealthINX)

A randomised controlled trial complemented with biosignal diary data to evaluate a newly developed system for work-related stress management and prevention for older adults (mHealthINX) - mHealthINX

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51412
Enrollment
64
Registered
2022-04-13
Start date
2022-05-18
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the research does not aim at a particular mental health disorder. We aim to study healthy individuals with varying degrees of work-related stress and then see if that stress has been reduced through the intervention. stress wellbeing

Interventions

The participants in the intervention group are asked to use the 3 components of mHealthINX for 12 weeks: - PWA (pulse wave analysis) > Measure heart rate and heart rate - App on smartphone provided b
for example, the advice to do a mindfulness exercise, play a relaxing game or view an image in the VR environment.

Sponsors

Stichting tanteLouise
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: To be included in the study, participants need to i) be 50 years of age or older ii) currently holding a paid work for at least 24 hours per week (iii) have no record of repeated seizures or loss of balance, (iv) have enough language skills in German or Dutch to participate, v) give written and oral informed consent.

Exclusion criteria

Exclusion criteria: Participants that i)are younger than 50 years ii) work less than 24 hours a week iii) have a record of repeated seizures or loss of balance iv) do not have enough language skills in German or Dutch to participate v) do not give written and oral consent

Design outcomes

Primary

MeasureTime frame
The primary outcome is self-reported stress, including cognitive, somatic and general stress. We will use items from the Copenhagen Psychosocial Questionnaire6 (COPSOQIII). For the assessment of pre-post interventions stress we will use the SmartPWA to measure pulse waves and electrocardiogram.

Secondary

MeasureTime frame
In addition, several secondary outcomes will be assessed, also derived from the COPSOQIII: - Self-rated health - Burnout symptoms - Depressive symptoms - Sleep quality Because occupational well-being is contingent to psychosocial factors at work, we will also assess job demands and resources as well as work-person interface parameters. These assessments will help the system to improve the suggestions for interventions. Within the trial, this data could also unearth potential mediating effects of these variables between the experimental group (control vs. intervention group) and the aforementioned health-related outcomes. For the assessment of job demands and resources and work-person interface we have used items from COPSOQIII and the Work Design Questionnaire7 (WDQ). Assessed variables are: Job demands: Quantitative demands, emotional demands, physical demands, work pace, job insecurity, cognitive demands Job resources: role clarity, support from supervisor, support from colleagues, sense of community at work, meaning of work, autonomy, task variety, possibilities for development, feedback from others. Work-person interface: Work engagement, job satisfaction, work-life conflict, self-efficacy. Finally, participants in the intervention group will fill out the System Usability Scale (SUS)8 and additional questions about technology acceptance, usability and user-experience regarding the mHealthINX system in order to receive additional information and feedback from their perspective. Communication and user involvement will be assessed based on the log files of the mHealthINX system.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 27, 2026