NCT05274529

Brief Summary

In this study the effects of a technology-driven workplace wellbeing intervention programme on employees' wellbeing, productivity (presenteeism) and absenteeism will be studied with the help of mobile applications and remotely conducted questionnaires, different wellbeing intervention periods and HRV based measurements.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Apr 2022Oct 2026

First Submitted

Initial submission to the registry

January 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 12, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4.5 years

First QC Date

January 26, 2022

Last Update Submit

March 4, 2024

Conditions

Keywords

workplacewellbeinginterventionabsenteeismpresenteeismstressburnout

Outcome Measures

Primary Outcomes (6)

  • The change in work productivity loss (presenteeism) by WLQ

    The change in work productivity loss (presenteeism) is assessed by repeating Work Limitations Questionnaires (WLQ). WLQ results are on a scale from 0 to 100 where 0 means no limitations to work (=best result) and 100 means the most limitations to work (=worst result)

    0, 4, 8, 12, 24 and 36 months from start

  • The change in work productivity loss (presenteeism) by HPQ

    The change in work productivity loss (presenteeism) is assessed by repeating Health and Work Performance Questionnaires (HPQ). HPQ scale goes from 0 to 10 where 10 means the best health and work performance.

    0, 4, 8, 12, 24 and 36 months from start

  • The change in work ability

    The change in work ability is assessed by repeating work ability index (WAI) questionnaires. WAI scores are on a scale from 7 to 49 points where 7 is the poorest and 49 is the best work ability.

    0, 12, 24 and 36 months from start

  • The change in sick-leaves (absenteeism) by absenteeism records

    The change in sick-leaves (absenteeism) are assessed via employer absenteeism records

    0, 12, 24 and 36 months from start

  • The change in sick-leaves (absenteeism) by HPQ

    The change in sick-leaves (absenteeism) are assessed via repeating Health and Work Performance Questionnaires (HPQ). HPQ scale goes from 0 to 10 where 10 means the best health and work performance.

    0, 12, 24 and 36 months from start

  • The change in sick-leaves (absenteeism) by WAI

    The change in sick-leaves (absenteeism) are assessed via repeating work ability index (WAI) questionnaires. WAI scores are on a scale from 7 to 49 points where 7 is the poorest and 49 is the best work ability.

    0, 12, 24 and 36 months from start

Secondary Outcomes (13)

  • The change in autonomic nervous system function and health behaviors based on HRV

    0, 4, 8, 12, 24 and 36 months from start

  • The change in autonomic nervous system function and health behaviors based on measured stress/recovery

    0, 4, 8, 12, 24 and 36 months from start

  • The change in autonomic nervous system function and health behaviors based on measured sleep

    0, 4, 8, 12, 24 and 36 months from start

  • The change in autonomic nervous system function and health behaviors based on measured physical activity

    0, 4, 8, 12, 24 and 36 months from start

  • The change in autonomic nervous system function and health behaviors based on measured physical fitness

    0, 4, 8, 12, 24 and 36 months from start

  • +8 more secondary outcomes

Study Arms (1)

Study group

EXPERIMENTAL

All the participants will be in the same group and have the same intervention programmes options to choose from.

Behavioral: Psychological health and flexibilityBehavioral: Work abilityBehavioral: Sleep and recoveryBehavioral: Healthy lifestyleOther: No coaching

Interventions

A remote coaching programme concentrating on psychological health and flexibility

Study group
Work abilityBEHAVIORAL

A remote coaching programme concentrating on work ability

Study group

A remote coaching programme concentrating on sleep and recovery

Study group

A remote coaching programme concentrating on healthy lifestyle

Study group

Participants also have the option to choose no coaching for the coming 3 month period.

Study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Adequate Finnish or English1 language skills to comprehend study-related instructions and questionnaires. The services and contents are available only in Finnish and English.

You may not qualify if:

  • Planned absenteeism from work during the study with \>3mth duration
  • Use of cardiac pacemaker or history of atrial fibrillation
  • No access to compatible mobile phone
  • History of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aisti Health Oy

Helsinki, 00100, Finland

Location

MeSH Terms

Conditions

Occupational StressBurnout, ProfessionalBurnout, Psychological

Interventions

Mental HealthPliabilitySleepSalvage Therapy

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HealthPopulation CharacteristicsMechanical PhenomenaPhysical PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeutics

Study Officials

  • Jari Parkkari, Dr

    Professor at University of Jyväskylä

    STUDY CHAIR
  • Tero Myllymäki, M.Sc.

    Head of Physiology Research at Firstbeat Technologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a pre-post type intervention study where baseline measurements are made at 0 months from the study start and follow up measurements are made at 4, 8 ,12, 24 and 36 months.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

March 10, 2022

Study Start

April 12, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations