ErgonomicsSujuKENCT03573674
Improving Work Flow Through Cognitive Ergonomics. An Intervention Study
A study testing CE - Cognitive Ergonomics (KERGO) and RS - Recovery Support (KUORMA) in people with Ergonomics, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial summary
The main aim of the SujuKE study is to test the effectiveness of workplace cognitive ergonomics development program designed to decrease cognitively disrupting work conditions and work-related cognitive stress, and to improve work flow. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ergonomics
- What is being tested?
- CE - Cognitive Ergonomics (KERGO) and RS - Recovery Support (KUORMA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 927 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participating organization offers several comparable teams (regarding type of tasks and demands) for study
- The participating units (in organizations) include knowledge workers, such as office workers and experts
- Whose
- work tasks are cognitively rather than physically demanding
- work requires learning and updating knowledge and skills
- information and communication technology is the main tool at work.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Institute of Occupational Health
Helsinki, Etelä-Suomi, 00250
About this study
Official title: SujuKE - Improving Work Flow Through Cognitive Ergonomics. An Intervention Study
The main aim of the SujuKE study is to test the effectiveness of workplace cognitive ergonomics development program designed to decrease cognitively disrupting work conditions and work-related cognitive stress, and to improve work flow. The cognitive ergonomics workplace intervention includes cognitive ergonomics workshop, work experiments, and intervention task questionnaires. Its effect on changes in subjective measures of work conditions, work flow, stress, and work productivity will be studied. The hypothesis is that cognitive ergonomics intervention decreases the level of cognitive strain related to work conditions, and this change is associated with higher level in work flow, well-being, and productivity at work.
Read the detailed description
In the modern work life, performing work tasks rely on cognitive function, i.e. mental processes that are involved in processing information, such as attention, working memory, decision making and learning. Furthermore, the conditions at work include situations that require cognitive capacity. Information overload, multitasking and interruptions are typical features in any work. Thus, in the modern work life, work is knowledge work or information work by nature, and cognitive strain is a notable psychosocial risk factor. Not only task demands per se can exceed natural limitations of human cognitive capacities, but also the conditions at work can make it demanding for a human to perform.
Research shows that psychosocial stress, including cognitive stress, challenges wellbeing, safety and productivity at work. Cognitively straining conditions, such as disruptions, interruptions and information overload are related to higher levels of work stress, occupational accidents, and cognitive failures at work. It is essential to decrease harmful consequences to individual workers, organizations, and the society by managing psychosocial risks typical to cognitively demanding work tasks and conditions.
SujuKE study focuses on ergonomics (or human factors) practices that aim to ensure 'appropriate interaction between work, product and environment, and human needs, capabilities and limitations'. In cognitive ergonomics, the focus is on making human-system interaction compatible with human cognitive abilities and limitations, particularly at work. The aim is to apply general principles and good practices of cognitive ergonomics that help to avoid unnecessary cognitive load at work and that improve human performance.
The aim of the SujuKE study is to improve the conditions of knowledge work and promote the flow of work and reduce work strain. There are studies which show that decreasing disruptions, providing uninterrupted working time, and reducing information may lead to improved work flow and productivity. In the SujuKE-study, several sources of cognitive strain are restricted and concrete methods to help improve cognitive ergonomics will be worked on and implemented at workplace. The objective of the project is to obtain research evidence of the effects of cognitive ergonomics development programme on working conditions, the flow of work, well-being at work, and the productivity at work.
During the SujuKE project, the investigators will implement measures at the workplace that aim to facilitate work and reduce strain. The objective of the project is to obtain research evidence of the effects of these measures on working conditions, the flow of work, well-being at work, and the productivity at work. The study is carried out by the Finnish Institute of Occupational Health (FIOH) and funded by the Finnish Work Environment Fund.
- Conditions
- Ergonomics
- Being tested
- CE - Cognitive Ergonomics (KERGO), RS - Recovery Support (KUORMA)
- Keywords
- Working conditions,, cognitive load, disruptions, interruptions, information overload, Mental contrasting with implementation intentions MCII, Cognitive ergonomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE - Cognitive Ergonomics (KERGO)Behavioural
CE "Cognitive ergonomics Intervention" deals with themes such as disruptions, interruptions, information overload.
A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method
RS - Recovery Support (KUORMA)Behavioural
RS "Recovery Support / Stress Management Intervention" deals with themes such as workload management, recovery, work-family balance.
A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method
| Study group | Role | What they receive |
|---|---|---|
| Cognitive ergonomics Intervention | Experimental | Not described Receives: Behavioral: CE - Cognitive Ergonomics (KERGO) |
| Stress management Intervention | Active comparator | Not described Receives: Behavioral: RS - Recovery Support (KUORMA) |
| Passive control | No intervention | "Passive Control" groups receive no intervention at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive strain prevalence
Cognitive strain prevalence measures prevalence of disruptions, interruptions, and information overload.
There are two items on disruptions, three items on interruptions, and seven items on information overload including memory load, multitasking, and problems with instructions (Brain@Work survey by FIOH).
Response scale is from 1 to 5, higher number indicating higher prevalence (Scale: More rarely; Monthly; Weekly; Daily, or almost daily; Many times a day) Total score is a factor score including all 12 items.
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Secondary outcomes (8)
Change in subjective Cognitive load
Measured a) for the main themes of the intervention study. There are two items on disruptions, three items on interruptions, and seven items on information overload including memory load, multitasking, and problems with instructions (Brain@Work survey by FIOH).
Furthermore, measured b) with all 39 items from FIOH Brain@Work Index questionnaire including 13 subscales.
Response scale is from -3 to 3 (seven-point), negative values reflecting motivation-energization, positive values reflecting strain, zero reflecting neither. Higher number indicates higher load (Scale: Motivate-Energize Very much; Quite a lot; Somewhat; Cause strain Somewhat; Quite a lot; Very much).
Total scores are averaged a) over the 12 items (disruptions, interruptions, information overload) and b) over the 39 items (all 13 subscales) weighted with their estimated prevalence (5 point scale, higher values reflecting higher prevalence).
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Recovery
Includes 1 item recovery measure. Measured with question: "How well do you usually feel that you recover from the strain caused by your work (both mental and physical) after your working day/work shift?". Scale from 0 (very poorly) to 10 (very well).
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in stress
Includes 1 item stress measure. Measured with question "By stress we mean a situation in which a person feels tense, restless, nervous, or anxious, or they find it difficult to sleep because they cannot switch off their thoughts. Do you currently feel this kind of stress? (Choose the option that best suits you)". Scale from 0 (not at all) to 10 (very much).
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Burnout index
Burnout is measured with The Copenhagen Psychosocial Questionnaire II (COPSOQ-II) Burnout Index (Pejtersen, Kristensen, Borg, \& Bjorner, 2010). The index includes four items. Scale: Not at all; A small part of the time; Part of the time; A large part of the time; All the time). Each item is scored 0-100 (0, 25, 50, 75, and 100), higher values indicating higher level of burnout. Total score is averaged over the four items.
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in General health
Includes 1 item general health measure. Measured with question: "In general: would you say that your health is:" Scale: from 1 to 5, higher number indicating better health (Poor, Fairly poor, Average, Fairly good, Good).
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in subjective presenteeism
Presenteeism / Subjective productivity Health at Work (HPQ) survey (World Health Organization, WHO 2001) questions B14: how would you rate your usual job performance over the past year or two? (Scale 0-10 with 10 being top performance) and B15: how would you rate your overall job performance on the days you worked during the past 4 weeks (28 days)? (Scale 0-10 with 10 being top performance)
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Cognitive stress symptoms
Cognitive stress symptoms are measured with COPSOPQ-II Cognitive Stress Index (Pejtersen, Kristensen, Borg, \& Bjorner, 2010). The index includes four items (scale: Not at all; A small part of the time; Part of the time; A large part of the time; All the time). Each item is scored 0-100 (0, 25, 50, 75, and 100), higher values indicating higher level of stress symptoms.
Total score is averaged over the four items.
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End of treatment measures: 18-28 weeks after baseline.
Change in Work flow
Work flow is measured as cognitive failure at work with three subscales. a) Workplace Cognitive Failure Scale (WCFS) memory sub-scale includes five items, b) WCFS attention sub-scale includes five items (Wallace \& Chen 2005), and c) FIOH Cognitive failure: Multitasking subscale includes three items.
The scale is from one to five (More rarely; Monthly; Weekly; Daily, or almost daily; Many times a day), higher number indicating higher prevalence of cognitive failure and lower work flow.
Total scores are averaged for each subscale: WCFS memory, WCFS attention, and FIOH multitasking.
Measured: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End of treatment measures: 18-28 weeks after baseline. .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ErgonomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization with stratification allocated groups selected by participating organizations to treatment and control groups. Primary stratification was by the organization. Within-organization stratification took into account the size, the type of work tasks and the response rate in the first survey of cluster. Participating organizations entered all together to 36 clusters, each with individuals for the intervention and active control groups (N=638 individuals). The intervention (and active control) receive different types of workshops, individual tasks and team tasks. Additional information is available from non-randomized passive control group (N=289 individuals). Participating organizations were recruited by informing about the study. Participating units included knowledge workers, whose work tasks are cognitively rather than physically demanding.
- Masking
- None (open label)
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Work Environment Fund
- Responsible party
- Sponsor
- Investigators
- Virpi SS Kalakoski, Dr, Principal investigator, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573674
- Sponsor's protocol ID
- 117155
- Other IDs
- 117155
- Acronym
- SujuKE
- Status last verified
- Apr 2020
- First submitted
- 24 May 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalakoski V, Selinheimo S, Valtonen T, Turunen J, Kapykangas S, Ylisassi H, Toivio P, Jarnefelt H, Hannonen H, Paajanen T. Effects of a cognitive ergonomics workplace intervention (CogErg) on cognitive strain and well-being: a cluster-randomized controlled trial. A study protocol. BMC Psychol. 2020 Jan 2;8(1):1. doi: 10.1186/s40359-019-0349-1.
PubMed 31898551
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SujuKE - Improving Work Flow Through Cognitive Ergonomics. An Intervention Study
- ClinicalTrials.gov ID
- NCT03573674
- Acronym / sponsor ID
- SujuKE / 117155
- Conditions
- Ergonomics
- Keywords
- Working conditions,, cognitive load, disruptions, interruptions, information overload, Mental contrasting with implementation intentions MCII, Cognitive ergonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- Finnish Work Environment Fund
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the SujuKE study is to test the effectiveness of workplace cognitive ergonomics development program designed to decrease cognitively disrupting work conditions and work-related cognitive stress, and to improve work flow. The cognitive ergonomics workplace intervention includes cognitive ergonomics workshop, work experiments, and intervention task questionnaires. Its effect on changes in subjective measures of work conditions, work flow, stress, and work productivity will be studied. The hypothesis is that cognitive ergonomics intervention decreases the level of cognitive strain related to work conditions, and this change is associated with higher level in work flow, well-being, and productivity at work.
Detailed description
In the modern work life, performing work tasks rely on cognitive function, i.e. mental processes that are involved in processing information, such as attention, working memory, decision making and learning. Furthermore, the conditions at work include situations that require cognitive capacity. Information overload, multitasking and interruptions are typical features in any work. Thus, in the modern work life, work is knowledge work or information work by nature, and cognitive strain is a notable psychosocial risk factor. Not only task demands per se can exceed natural limitations of human cognitive capacities, but also the conditions at work can make it demanding for a human to perform.
Research shows that psychosocial stress, including cognitive stress, challenges wellbeing, safety and productivity at work. Cognitively straining conditions, such as disruptions, interruptions and information overload are related to higher levels of work stress, occupational accidents, and cognitive failures at work. It is essential to decrease harmful consequences to individual workers, organizations, and the society by managing psychosocial risks typical to cognitively demanding work tasks and conditions.
SujuKE study focuses on ergonomics (or human factors) practices that aim to ensure 'appropriate interaction between work, product and environment, and human needs, capabilities and limitations'. In cognitive ergonomics, the focus is on making human-system interaction compatible with human cognitive abilities and limitations, particularly at work. The aim is to apply general principles and good practices of cognitive ergonomics that help to avoid unnecessary cognitive load at work and that improve human performance.
The aim of the SujuKE study is to improve the conditions of knowledge work and promote the flow of work and reduce work strain. There are studies which show that decreasing disruptions, providing uninterrupted working time, and reducing information may lead to improved work flow and productivity. In the SujuKE-study, several sources of cognitive strain are restricted and concrete methods to help improve cognitive ergonomics will be worked on and implemented at workplace. The objective of the project is to obtain research evidence of the effects of cognitive ergonomics development programme on working conditions, the flow of work, well-being at work, and the productivity at work.
During the SujuKE project, the investigators will implement measures at the workplace that aim to facilitate work and reduce strain. The objective of the project is to obtain research evidence of the effects of these measures on working conditions, the flow of work, well-being at work, and the productivity at work. The study is carried out by the Finnish Institute of Occupational Health (FIOH) and funded by the Finnish Work Environment Fund.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomization with stratification allocated groups selected by participating organizations to treatment and control groups. Primary stratification was by the organization. Within-organization stratification took into account the size, the type of work tasks and the response rate in the first survey of cluster. Participating organizations entered all together to 36 clusters, each with individuals for the intervention and active control groups (N=638 individuals). The intervention (and active control) receive different types of workshops, individual tasks and team tasks. Additional information is available from non-randomized passive control group (N=289 individuals). Participating organizations were recruited by informing about the study. Participating units included knowledge workers, whose work tasks are cognitively rather than physically demanding.
| Arm | Type | Receives |
|---|---|---|
| Cognitive ergonomics Intervention | Experimental | Behavioral: CE - Cognitive Ergonomics (KERGO) |
| Stress management Intervention | Active comparator | Behavioral: RS - Recovery Support (KUORMA) |
| Passive control | No intervention | –"Passive Control" groups receive no intervention at all. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participating organization offers several comparable teams (regarding type of tasks and demands) for study
- The participating units (in organizations) include knowledge workers, such as office workers and experts
- Whose
- work tasks are cognitively rather than physically demanding
- work requires learning and updating knowledge and skills
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CE - Cognitive Ergonomics (KERGO)CE "Cognitive ergonomics Intervention" deals with themes such as disruptions, interruptions, information overload. A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method | Behavioural | Cognitive ergonomics Intervention |
| RS - Recovery Support (KUORMA)RS "Recovery Support / Stress Management Intervention" deals with themes such as workload management, recovery, work-family balance. A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method | Behavioural | Stress management Intervention |
Primary outcome
Change in cognitive strain prevalence
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Cognitive strain prevalence measures prevalence of disruptions, interruptions, and information overload. There are two items on disruptions, three items on interruptions, and seven items on information overload including memory load, multitasking, and problems with instructions (Brain@Work survey by FIOH). Response scale is from 1 to 5, higher number indicating higher prevalence (Scale: More rarely; Monthly; Weekly; Daily, or almost daily; Many times a day) Total score is a factor score including all 12 items.
8 secondary outcomes
Change in subjective Cognitive load
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Recovery
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in stress
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Burnout index
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in General health
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in subjective presenteeism
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment
Change in Cognitive stress symptoms
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End of treatment measures: 18-28 weeks after baseline.
Change in Work flow
Time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End of treatment measures: 18-28 weeks after baseline. .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 31898551Kalakoski V, Selinheimo S, Valtonen T, Turunen J, Kapykangas S, Ylisassi H, Toivio P, Jarnefelt H, Hannonen H, Paajanen T. Effects of a cognitive ergonomics workplace intervention (CogErg) on cognitive strain and well-being: a cluster-randomized controlled trial. A study protocol. BMC Psychol. 2020 Jan 2;8(1):1. doi: 10.1186/s40359-019-0349-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virpi SS Kalakoski, Dr principal investigator
Finnish Institute of Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE - Cognitive Ergonomics (KERGO) and RS - Recovery Support (KUORMA) in people with Ergonomics, run by Finnish Institute of Occupational Health at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive strain prevalence (time frame: 1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End-of-treatment measurements: 18-28 weeks after the baseline measurements. 3: Follow-up 4m: 16 weeks after the end-of-treatment. 4: Follow-up 10m: 40 weeks after end-of-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.