Promo@Work Entrepreneurs (Promo@Work)

August 24, 2018 updated by: Jaana Laitinen, Finnish Institute of Occupational Health

The Effects of Counselling Delivered Through Native Mobile Application on Work Ability and Work Recovery Among Micro-entrepreneurs

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oulu, Finland, 90220
        • Finnish Institute of Occupational Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: behavioral
work recovery intervention
Recover! app: one hour weekly for two months
Experimental: waiting list control
work recovery intervention after 6 months
no treatment during 6 months,then Recover! app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline in need for recovery scale at 6 months
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
change from baseline in perceived work ability at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months
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
change from baseline in Recovery Experiences at 6 months
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
change from baseline in work performance at 6 months
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
change from baseline in sleep deprivation at 6 months
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.
change from baseline in insomnia symptoms at 6 months
nutritional behaviour
Time Frame: change from baseline in nutritional behaviour at 6 months
number of meals and snacks per day
change from baseline in nutritional behaviour at 6 months
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
change from baseline in Audit-C at 6 months
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)
change from baseline in physical activity at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose of intervention
Time Frame: from baseline until 2 months
dose of Recover application (using time in hours and minutes during two months)
from baseline until 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jaana Laitinen, PhD, Docent, Chief Specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Anticipated)

August 30, 2018

Study Completion (Anticipated)

March 31, 2019

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 3522101
  • 303430 (Other Grant/Funding Number: Strategic Research Council at the Academy of Finland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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