We hypothesise that mHealthINX will help lower stress in 50+ workers, as assessed both through pulse wave analysis & electrocardiogram analysis (i.e. biosignals captured through the hand-held SmartPWA3 developed by AIT) and self-reported…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
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.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
There is an EU subsidy program within the framework of the AAL, whereby
innovations in (elderly) care are stimulated. It concerns a collaboration
between 9 parties in 3 different countries and runs from March 2020 to February
2023. TanteLouise is a partner in this project and is involved as an end user
with knowledge of the elderly, elderly care and the employees who work in it.
Within the project, a prevention program is being developed for employees with
the aim of better managing their (work) stress. This involves measuring,
assessing and understanding one's own stress level. During the study,
participants can use the interventions that are offered via a smartphone and VR
glasses.
The project has completed a development phase; experiences have been gathered
from end users in, among other things, surveys and workshops. This feedback has
been processed into a final prototype, which is used in the study.
Study objective
We hypothesise that mHealthINX will help lower stress in 50+ workers, as
assessed both through pulse wave analysis & electrocardiogram analysis (i.e.
biosignals captured through the hand-held SmartPWA3 developed by AIT) and
self-reported measures (i.e. questionnaires of somatic, cognitive and general
stress).
Study design
In the period January to November 2022, research will be conducted among 128
participants, spread over the Netherlands and Switzerland. Research partners in
the project are Medical University of Vienna (MUW) and Zurich University of
Applied Sciences (ZHAW).
In the Netherlands, 64 participants are recruited from the population of
employees of 50 years and older, who work for tanteLouise. Participants are
asked to participate in the study for 12 weeks. As described in the study
protocol, this group is divided into intervention and control groups by means
of randomisation.
The participants in the intervention group are asked to use the 3 components of
mHealthINX for 12 weeks:
- PWA (pulse wave analysis) > non-intrusive measure of heart rate variability
- App on smartphone > Developed within the project
- VR glasses > Software developed within the project
The stress level can be measured by using the PWA device, but also by answering
questions in the app on the smartphone and filling the logbook function in the
app.
The app then gives advice based on these results; for example, the advice to do
a mindfulness exercise, play a relaxing game or view an image in the VR
environment.
By using the system at various times during the week during the test period,
the participant gets to know his/her own stress factors and moments, and at the
same time the participant learns which interventions are effective for him/her.
Both the intervention group and the control group are asked to complete an
online questionnaire 3 times, namely in weeks 0, 6 and 12. The questionnaires
are described in detail in the study protocol and have been added as an
appendix.
Intervention
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 by the project > Developed within the project
- VR glasses > Software developed within the project
The stress level can be measured by using the PWA device, but also by answering
questions in the app on the smartphone and filling the logbook function in the
app.
The app then gives advice based on these results; for example, the advice to do
a mindfulness exercise, play a relaxing game or view an image in the VR
environment.
Study burden and risks
VR headsets can sometimes lead to headache or dizziness. Participants are
debriefed of this potential risk in the informed consent and prompted to stop
using the headset if headaches persist.
In addition, participants can become more aware of their own stress level
(more/ less and whether or not related to work) than before participating in
the study. There is a support system (manager, HR advisor and social advisor)
available for employees if they need it.
Boerenverdriet 18
Bergen op Zoom 4613AK
NL
Boerenverdriet 18
Bergen op Zoom 4613AK
NL
Listed location countries
Age
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
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
Recruitment
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In other registers
| Register | ID |
|---|---|
| CCMO | NL79919.028.21 |