- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573674
Improving Work Flow Through Cognitive Ergonomics. An Intervention Study (SujuKE)
SujuKE - Improving Work Flow Through Cognitive Ergonomics. An Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Etelä-Suomi
-
Helsinki, Etelä-Suomi, Finland, 00250
- Finnish Institute of Occupational Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The participants in the study work in the participating organizations were recruited through direct contacts and by informing about the study in various events.
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive ergonomics Intervention
|
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 |
|
Active Comparator: Stress management Intervention
|
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 |
|
No Intervention: Passive control
"Passive Control" groups receive no intervention at all.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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). |
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
|
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).
|
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
|
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).
|
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
|
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.
|
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
|
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).
|
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
|
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)
|
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.
|
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. |
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. .
|
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. |
1: Baseline measurements: 10-16 weeks before the intervention phase. 2: End of treatment measures: 18-28 weeks after baseline. .
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Virpi SS Kalakoski, Dr, Finnish Institute of Occupational Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 117155 (The Finnish Work Environment Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Ergonomics
-
Washington University School of MedicineIntuitive Surgical; Southern Illinois University; Society of American Gastrointestinal...Terminated
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaNot yet recruiting
-
University of PrimorskaInnorenew CoECompleted
-
Brigham and Women's HospitalRampart ic, LLCRecruitingWellness | Ergonomics | Orthopedic InjuryUnited States
-
Stanford UniversityNot yet recruitingErgonomicsUnited States
-
University of Southern DenmarkRegion of Southern Denmark; Sygekassernes Helsefond; Axel Muusfeldts fondCompleted
-
University of Southern DenmarkRegion of Southern Denmark; Sygekassernes Helsefond; Axel Muusfeldts fondCompleted
-
Meander Medical CenterWilhemina Ziekenhuis AssenUnknownErgonomicsNetherlands
-
Istanbul University - Cerrahpasa (IUC)CompletedHealth Behavior | Ergonomics | Online EducationTurkey
-
Mayo ClinicCompleted
Clinical Trials on CE - Cognitive Ergonomics (KERGO)
-
Erkin Oğuz SARINot yet recruitingPost-Traumatic Stress DisorderTurkey