- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648593
Promo@Work Entrepreneurs (Promo@Work)
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oulu, Finland, 90220
- Finnish Institute of Occupational Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Jaana Laitinen, PhD, Docent, Chief Specialist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 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)?
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.
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