Work AbilityPromo@WorkNCT03648593
Promo@Work Entrepreneurs
A study testing work recovery intervention in people with Work Ability and Work-Related Condition, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Ability, Work-Related Condition, Health Behavior
- What is being tested?
- work recovery intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,256 participants
- Where
- 1 siteFinland
- Study dates
- 18 Oct 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not full-time entrepreneurs
- on sick leave
- absent from work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Work Ability, Work-Related Condition, Health Behavior, Intervention
- Being tested
- work recovery intervention, waiting list control
- Keywords
- microenterpreneur, work ability, work recovery, native mobile app, health behaviour, work, stress, work performance
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
work recovery interventionBehavioural
Recover! app: one hour weekly for two months
waiting list controlBehavioural
no treatment during 6 months,then Recover! app
| Study group | Role | What they receive |
|---|---|---|
| behavioral | Experimental | work recovery intervention Receives: Behavioral: work recovery intervention |
| waiting list control | Experimental | work recovery intervention after 6 months Receives: Behavioral: waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in need for recovery scale at 6 months
need for recovery scale measures early symptoms of fatigue
Measured: 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
to rate their work ability on a scale of 0 to 10, ten being their lifetime best work ability
Measured: change from baseline in perceived work ability at 6 months
Secondary outcomes (8)
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)
Measured: 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
The Recovery Experience Questionnaire - a Measure for assessing recuperation and unwinding from work
Measured: change from baseline in Recovery Experiences at 6 months
World health organization Health and work performance questionnaire
World health organization Health and work performance questionnaire
Measured: change from baseline in work performance at 6 months
sleep deprivation questions
Sleep deprivation is calculated by subtracting hours slept from hours of sleep needed
Measured: change from baseline in sleep deprivation at 6 months
Frequency of insomnia symptoms
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.
Measured: change from baseline in insomnia symptoms at 6 months
nutritional behaviour
number of meals and snacks per day
Measured: change from baseline in nutritional behaviour at 6 months
Alcohol Use Disorders Identification Test Consumption (Audit-C)
the Finnish version of the questionnaire Alcohol Use Disorders Identification Test Consumption 3 questions
Measured: change from baseline in Audit-C at 6 months
physical activity questionnaire
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)
Measured: change from baseline in physical activity at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start18 Oct 2017
- Primary completion30 Aug 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work AbilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- randomized intervention trial with waiting list control
- Masking
- None (open label)
- Enrolment
- 1,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Tampere University, University Hospital of Cologne, Academy of Finland
- Responsible party
- Principal investigator, Jaana Laitinen, Finnish Institute of Occupational Health
- Investigators
- Jaana Laitinen, PhD, Docent, Principal investigator, Chief Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648593
- Sponsor's protocol ID
- 3522101
- Other IDs
- 303430
- Acronym
- Promo@Work
- Status last verified
- Aug 2018
- First submitted
- 24 May 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kekkonen M, Korkiakangas E, Laitinen J, Oinas-Kukkonen H. Factors Reducing the Use of a Persuasive mHealth App and How to Mitigate Them: Thematic Analysis. JMIR Hum Factors. 2023 Jun 26;10:e40579. doi: 10.2196/40579.
PubMed 37358883
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Counselling Delivered Through Native Mobile Application on Work Ability and Work Recovery Among Micro-entrepreneurs
- ClinicalTrials.gov ID
- NCT03648593
- Acronym / sponsor ID
- Promo@Work / 3522101
- Conditions
- Work Ability, Work-Related Condition, Health Behavior, Intervention
- Keywords
- microenterpreneur, work ability, work recovery, native mobile app, health behaviour, work, stress, work performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,256 participants (actual)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- University of Oulu, Tampere University, University Hospital of Cologne, Academy of Finland
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized intervention trial with waiting list control
| Arm | Type | Receives |
|---|---|---|
| behavioral | Experimental | Behavioral: work recovery interventionwork recovery intervention |
| waiting list control | Experimental | Behavioral: waiting list controlwork recovery intervention after 6 months |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- not full-time entrepreneurs
- on sick leave
- absent from work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| work recovery interventionRecover! app: one hour weekly for two months | Behavioural | behavioral |
| waiting list controlno treatment during 6 months,then Recover! app | Behavioural | waiting list control |
Primary outcome
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 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
8 secondary outcomes
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
Change from baseline in Recovery Experiences Questionnaire at 6 months
Time frame: 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
sleep deprivation questions
Time frame: change from baseline in sleep deprivation at 6 months
Frequency of insomnia symptoms
Time frame: change from baseline in insomnia symptoms at 6 months
nutritional behaviour
Time frame: 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
physical activity questionnaire
Time frame: change from baseline in physical activity at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Derived from this study: PubMed 37358883Kekkonen M, Korkiakangas E, Laitinen J, Oinas-Kukkonen H. Factors Reducing the Use of a Persuasive mHealth App and How to Mitigate Them: Thematic Analysis. JMIR Hum Factors. 2023 Jun 26;10:e40579. doi: 10.2196/40579.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaana Laitinen, PhD, Docent principal investigator
Chief Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing work recovery intervention in people with Work Ability and Work-Related Condition, run by Finnish Institute of Occupational Health at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in need for recovery scale at 6 months (time frame: change from baseline in need for recovery scale at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.