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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05274529
Other study ID # Coachbeat
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 12, 2022
Est. completion date October 2026

Study information

Verified date March 2024
Source Firstbeat Technologies Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The objectives of this study are: 1. To study the effects of a data driven adaptive workplace wellbeing intervention programme on productivity (presenteeism) and absenteeism of the employees. 2. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 571
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Psychological health and flexibility
A remote coaching programme concentrating on psychological health and flexibility
Work ability
A remote coaching programme concentrating on work ability
Sleep and recovery
A remote coaching programme concentrating on sleep and recovery
Healthy lifestyle
A remote coaching programme concentrating on healthy lifestyle
Other:
No coaching
Participants also have the option to choose no coaching for the coming 3 month period.

Locations

Country Name City State
Finland Aisti Health Oy Helsinki

Sponsors (4)

Lead Sponsor Collaborator
Firstbeat Technologies Oy Aisti Health Oy, Tampere University, University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 The change in autonomic nervous system function and health behaviors based on HRV The change in autonomic nervous system function and health behaviors is assessed by HRV (heart rate variability) 0, 4, 8, 12, 24 and 36 months from start
Secondary The change in autonomic nervous system function and health behaviors based on measured stress/recovery 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) 0, 4, 8, 12, 24 and 36 months from start
Secondary The change in autonomic nervous system function and health behaviors based on measured sleep 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) 0, 4, 8, 12, 24 and 36 months from start
Secondary The change in autonomic nervous system function and health behaviors based on measured physical activity 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) 0, 4, 8, 12, 24 and 36 months from start
Secondary The change in autonomic nervous system function and health behaviors based on measured physical fitness The change in autonomic nervous system function and health behaviors is assessed by measured physical fitness as assessed by VO2Max 0, 4, 8, 12, 24 and 36 months from start
Secondary The change in depression and mood by BBI-15 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". 0 and 12 months from start
Secondary The change in self-reported questionnaire measures 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. 0, 12, 24 and 36 months from start
Secondary The change in blood pressure The change in blood pressure is measured between the start and the end of the 12 month intervention period. 0 and 12 months from start
Secondary The change in weight The change in weight is measured between the start and the end of the 12 month intervention period. 0 and 12 months from start
Secondary The change in waist circumference The change in waist circumference is measured between the start and the end of the 12 month intervention period. 0 and 12 months from start
Secondary The change in neck circumference The change in neck circumference is measured between the start and the end of the 12 month intervention period. 0 and 12 months from start
Secondary Return of investment (ROI) Return of investment (ROI) is calculated through absenteeism statistics and self-reported presenteeism. 0, 12, 24 and 36 months from start
Secondary Company's financial performance Company's financial performance is evaluation is based on reported revenue and profit. 0, 12, 24 and 36 months from start
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