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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03648593
Other study ID # 3522101
Secondary ID 303430
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 18, 2017
Est. completion date March 31, 2019

Study information

Verified date August 2018
Source Finnish Institute of Occupational Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1256
Est. completion date March 31, 2019
Est. primary completion date August 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 68 Years
Eligibility 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 Design


Intervention

Behavioral:
work recovery intervention
Recover! app: one hour weekly for two months
waiting list control
no treatment during 6 months,then Recover! app

Locations

Country Name City State
Finland Finnish Institute of Occupational Health Oulu

Sponsors (5)

Lead Sponsor Collaborator
Finnish Institute of Occupational Health Academy of Finland, University Hospital of Cologne, University of Oulu, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other dose of intervention dose of Recover application (using time in hours and minutes during two months) from baseline until 2 months
Primary 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
Primary 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 change from baseline in perceived work ability at 6 months
Secondary 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
Secondary Change from baseline in Recovery Experiences Questionnaire 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
Secondary World health organization Health and work performance questionnaire World health organization Health and work performance questionnaire change from baseline in work performance at 6 months
Secondary sleep deprivation questions Sleep deprivation is calculated by subtracting hours slept from hours of sleep needed change from baseline in sleep deprivation at 6 months
Secondary 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. change from baseline in insomnia symptoms at 6 months
Secondary nutritional behaviour number of meals and snacks per day change from baseline in nutritional behaviour at 6 months
Secondary Alcohol Use Disorders Identification Test Consumption (Audit-C) the Finnish version of the questionnaire Alcohol Use Disorders Identification Test Consumption 3 questions change from baseline in Audit-C at 6 months
Secondary 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) change from baseline in physical activity at 6 months
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