- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05274529
Effects of Personal Technology Driven Workplace Wellbeing Intervention Programme on Wellbeing, Productivity (Presenteeism) and Absenteeism - an Intervention Study (Coachbeat)
Study Overview
Status
Conditions
Detailed Description
The objectives of this study are:
- To study the effects of a data driven adaptive workplace wellbeing intervention programme on productivity (presenteeism) and absenteeism of the employees.
- To study the effects of data driven adaptive workplace wellbeing interventions on employees' physical health measures and wellbeing. The secondary objective also includes studying whether the programme generates measurable financial savings.
This study is an intervention study where eligible participants will be offered a technologically delivered health promotion intervention which is personalized to their needs both in terms of content and timing within the 12-month intervention period. The outcomes are compared against their pre-intervention levels at both individual and group level. The study has no control group as it is not acceptable for the participating companies to offer participation only to part of their employees based on randomization due to expected positive impact of the intervention. The lack of the control group will be taken into account while analyzing and interpreting the study results.
The 12-month intervention period consists of access to Firstbeat Life (HRV & movement measurement based wellbeing service), Aava Medical's Aisti wellbeing assessment and four types of online coaching programmes plus option of no coaching. Every participant has continuous access to Firstbeat Life and Aisti during the entire intervention programme and may use them at any time they so desire. In addition, participants will use the Coachbeat mobile app which is used to instruct and communicate with the participants, to fill in all the study questionnaires at given times, and to promote use of Firstbeat Life and Aisti at given points of the study. Baseline measurements and measurements after 4 and 8 months give recommendations for participation to the online coaching based on Firstbeat Life and Aisti wellbeing assessment. The participants can choose the coaching program based on the recommendation or their own interest. They can participate several coaching programmes during the study. Each coaching programme lasts approximately 3 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland, 00100
- Aisti Health Oy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
The initial target population consists of generally healthy employees of selected employer companies from information intensive industries and jobs.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
All the participants will be in the same group and have the same intervention programmes options to choose from.
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A remote coaching programme concentrating on psychological health and flexibility
A remote coaching programme concentrating on work ability
A remote coaching programme concentrating on sleep and recovery
A remote coaching programme concentrating on healthy lifestyle
Participants also have the option to choose no coaching for the coming 3 month period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in work productivity loss (presenteeism) by WLQ
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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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)
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0, 4, 8, 12, 24 and 36 months from start
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The change in work productivity loss (presenteeism) by HPQ
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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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.
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0, 4, 8, 12, 24 and 36 months from start
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The change in work ability
Time Frame: 0, 12, 24 and 36 months from start
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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.
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0, 12, 24 and 36 months from start
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The change in sick-leaves (absenteeism) by absenteeism records
Time Frame: 0, 12, 24 and 36 months from start
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The change in sick-leaves (absenteeism) are assessed via employer absenteeism records
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0, 12, 24 and 36 months from start
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The change in sick-leaves (absenteeism) by HPQ
Time Frame: 0, 12, 24 and 36 months from start
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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.
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0, 12, 24 and 36 months from start
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The change in sick-leaves (absenteeism) by WAI
Time Frame: 0, 12, 24 and 36 months from start
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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.
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0, 12, 24 and 36 months from start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in autonomic nervous system function and health behaviors based on HRV
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors is assessed by HRV (heart rate variability)
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0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors based on measured stress/recovery
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors is assessed by measured stress/recovery.
Stress & recovery balance is scored on a scale from 0 to 100 in Firstbeat Life service (100 is the best score)
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0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors based on measured sleep
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors is assessed by measured sleep.
Sleep is scored on a scale from 0 to 100 in Firstbeat Life service (100 is the best score)
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0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors based on measured physical activity
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors is assessed by measured physical activity.
Physical activity is scored on a scale from 0 to 100 in Firstbeat Life service (100 is the best score)
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0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors based on measured physical fitness
Time Frame: 0, 4, 8, 12, 24 and 36 months from start
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The change in autonomic nervous system function and health behaviors is assessed by measured physical fitness as assessed by VO2Max
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0, 4, 8, 12, 24 and 36 months from start
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The change in depression and mood by BBI-15
Time Frame: 0 and 12 months from start
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The change in depression and mood are assessed by Bergen Burnout Indicator (BBI-15).
BBI-15 result is on a scale from 0 to 100 where scores from 0 to 74 mean "no burnout" and scores from 95 to 100 mean "severe burnout".
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0 and 12 months from start
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The change in self-reported questionnaire measures
Time Frame: 0, 12, 24 and 36 months from start
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Self-reported questionnaire measures are mental wellbeing, physical health, sleep and recovery, financial situation, social relationships, work-related information etc. in the Aisti Index wellbeing assessment.
Aisti assessment gives results on a scale from 0 to 100 (100 is best) for each area of life.
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0, 12, 24 and 36 months from start
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The change in blood pressure
Time Frame: 0 and 12 months from start
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The change in blood pressure is measured between the start and the end of the 12 month intervention period.
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0 and 12 months from start
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The change in weight
Time Frame: 0 and 12 months from start
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The change in weight is measured between the start and the end of the 12 month intervention period.
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0 and 12 months from start
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The change in waist circumference
Time Frame: 0 and 12 months from start
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The change in waist circumference is measured between the start and the end of the 12 month intervention period.
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0 and 12 months from start
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The change in neck circumference
Time Frame: 0 and 12 months from start
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The change in neck circumference is measured between the start and the end of the 12 month intervention period.
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0 and 12 months from start
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Return of investment (ROI)
Time Frame: 0, 12, 24 and 36 months from start
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Return of investment (ROI) is calculated through absenteeism statistics and self-reported presenteeism.
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0, 12, 24 and 36 months from start
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Company's financial performance
Time Frame: 0, 12, 24 and 36 months from start
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Company's financial performance is evaluation is based on reported revenue and profit.
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0, 12, 24 and 36 months from start
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jari Parkkari, Dr, Professor at University of Jyväskylä
- Principal Investigator: Tero Myllymäki, M.Sc., Head of Physiology Research at Firstbeat Technologies
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Coachbeat
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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