NCT03573674

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
927

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

May 24, 2018

Last Update Submit

April 2, 2020

Conditions

Keywords

Working conditions,cognitive loaddisruptionsinterruptionsinformation overloadMental contrasting with implementation intentions MCIICognitive ergonomics

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    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

  • +3 more secondary outcomes

Study Arms (3)

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.

Interventions

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

Cognitive ergonomics 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

Stress management Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Institute of Occupational Health

Helsinki, Etelä-Suomi, 00250, Finland

Location

Related Publications (1)

  • 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.

Study Officials

  • Virpi SS Kalakoski, Dr

    Finnish Institute of Occupational Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 29, 2018

Study Start

November 1, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations