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Promo@Work Entrepreneurs (Promo@Work)

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ClinicalTrials.gov Identifier: NCT03648593
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborators:
University of Oulu
Tampere University
University Hospital of Cologne
Academy of Finland
Information provided by (Responsible Party):
Jaana Laitinen, Finnish Institute of Occupational Health

Brief Summary:

A randomized intervention study to promote work recovery and work ability among micro-entrepreneurs. The main aim is to investigate if the use of Recovery! -application results in better work recovery and work ability than no treatment for micro-entrepreneurs.

The plan of action of the study merges: 1) the contents that are based on the needs of the target population and evidence from research on work related and health behaviour enhancing work recovery, 2) theoretical framework for the counselling, 3) counselling methods including behaviour change techniques, and 4) tailoring the content and counselling according to trans theoretical change model and physical work demands. The intervention is delivered through native mobile application designed by using the abovementioned methodology.

Data are collected by repeated internet-based questionnaires (at baseline, 2 and 6 months from the beginning of the intervention) and from the use of mobile application. Furthermore, randomly selected persons in two groups (20-30 persons in each) are interviewed. Process evaluation is conducted to detect the mechanisms of change and to study why the program succeeded or failed.


Condition or disease Intervention/treatment Phase
Work Ability Work-Related Condition Health Behavior Intervention Behavioral: work recovery intervention Behavioral: waiting list control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1256 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: randomized intervention trial with waiting list control
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Counselling Delivered Through Native Mobile Application on Work Ability and Work Recovery Among Micro-entrepreneurs
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
Experimental: behavioral
work recovery intervention
Behavioral: work recovery intervention
Recover! app: one hour weekly for two months

Experimental: waiting list control
work recovery intervention after 6 months
Behavioral: waiting list control
no treatment during 6 months,then Recover! app




Primary Outcome Measures :
  1. change from baseline in need for recovery scale at 6 months [ Time Frame: change from baseline in need for recovery scale at 6 months ]
    need for recovery scale measures early symptoms of fatigue

  2. change from baseline in perceived work ability at 6 months. One item of work ability index [ Time Frame: change from baseline in perceived work ability at 6 months ]
    to rate their work ability on a scale of 0 to 10, ten being their lifetime best work ability


Secondary Outcome Measures :
  1. change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months [ Time Frame: change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months ]
    "At my work, I feel bursting with energy" (vigor); (2) "I am enthusiastic about my job"(dedication);(3)"I am immersed in my work" (absorption)

  2. Change from baseline in Recovery Experiences Questionnaire at 6 months [ Time Frame: change from baseline in Recovery Experiences at 6 months ]
    The Recovery Experience Questionnaire - a Measure for assessing recuperation and unwinding from work

  3. World health organization Health and work performance questionnaire [ Time Frame: change from baseline in work performance at 6 months ]
    World health organization Health and work performance questionnaire

  4. sleep deprivation questions [ Time Frame: change from baseline in sleep deprivation at 6 months ]
    Sleep deprivation is calculated by subtracting hours slept from hours of sleep needed

  5. Frequency of insomnia symptoms [ Time Frame: change from baseline in insomnia symptoms at 6 months ]
    Symptoms of insomnia are difficulties falling asleep, waking up at nights, waking up too early in the morning unable to fall asleep again and feeling of sleep which does not refresh. How often have you had this kind of symptoms during last 3 months?" Answers were given using Likert-scale: 1) Never or less than once a month, 2) less than once a week, 3) 1-2 days a week, 4) 3-5 days a week or 5) daily or almost daily.

  6. nutritional behaviour [ Time Frame: change from baseline in nutritional behaviour at 6 months ]
    number of meals and snacks per day

  7. Alcohol Use Disorders Identification Test Consumption (Audit-C) [ Time Frame: change from baseline in Audit-C at 6 months ]
    the Finnish version of the questionnaire Alcohol Use Disorders Identification Test Consumption 3 questions

  8. physical activity questionnaire [ Time Frame: change from baseline in physical activity at 6 months ]
    frequency in light and brisk physical activities (daily, four to six times a week, two to three times a week, once a week, two to three times a month, and once a month or less often). The duration of one bout of activity was considered separately for light and brisk activities (over 90 minutes, 60 to 90 minutes, 40 to59 minutes, 20 to 39 minutes, less than 20 minutes, and not at all)


Other Outcome Measures:
  1. dose of intervention [ Time Frame: from baseline until 2 months ]
    dose of Recover application (using time in hours and minutes during two months)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Finnish-speaking micro-entrepreneurs (those with enterprise of 1-9 employees),
  • company is located in Finland.
  • work full-time as entrepreneurs,
  • understand Finnish,
  • use an Android phone.

Exclusion Criteria:

  • not full-time entrepreneurs
  • on sick leave
  • absent from work

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648593


Locations
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Finland
Finnish Institute of Occupational Health
Oulu, Finland, 90220
Sponsors and Collaborators
Finnish Institute of Occupational Health
University of Oulu
Tampere University
University Hospital of Cologne
Academy of Finland
Investigators
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Principal Investigator: Jaana Laitinen, PhD, Docent Chief Specialist

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Responsible Party: Jaana Laitinen, Chief Specialist, Principal Investigator, PhD,, Finnish Institute of Occupational Health
ClinicalTrials.gov Identifier: NCT03648593    
Other Study ID Numbers: 3522101
303430 ( Other Grant/Funding Number: Strategic Research Council at the Academy of Finland )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaana Laitinen, Finnish Institute of Occupational Health:
microenterpreneur
work ability
work recovery
native mobile app
health behaviour
work
stress
work performance