- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06495801
Effectiveness of a Mobile Application in Improving Employees' Social Well-being.
Työntekijöiden Sosiaalisen Hyvinvoinnin lisääminen Mobiilisovelluksen Avulla (Effectiveness of a Mobile Application in Improving Employees' Social Well-being)
The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are:
Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees?
Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms).
Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.
Study Overview
Status
Intervention / Treatment
Detailed Description
Participants will be recruited from workplaces that use the Frendie PRO mobile application. After collecting baseline data, each workplace will be randomly assigned to treatment or control conditions. The unit of randomization is a workplace (or a team or department in bigger organizations).
The intervention group will be encouraged to download and start using the Frendie PRO mobile application. The control group will be informed of the date when they will have access to it (six months after the baseline).
Both groups are asked to participate in two follow-ups - a 3-month follow-up and a 6-month follow-up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Savonia
-
Kuopio, North Savonia, Finland, 70110
- University of Eastern Finland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All employees working at the company/team/department participating in the study and starting to use the Frendie PRO mobile application within the study period.
- Ability to fill the questionnaires online in Finnish
Exclusion Criteria:
- incapable of using questionnaire online
- does not know Finnish well enough to answer the questions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
Frendie PRO mobile application offers employees an environment to manage their social relationships, organize leisure activities, and discuss personal or work-related matters.
|
|
No Intervention: Wait-list controls
The group will have access to the mobile application after the six-month follow-up period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
University of California, Los Angeles (UCLA) Loneliness Scale
|
Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
|
Social Isolation
Time Frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
The Social Isolation scale was modified from an index used by Christiansen et al. (2021). Christiansen and colleagues, in turn, created it inspired by the detailed Social Network Index created by Berkman and Syme (1979). Communication frequency with the following groups is measured:
|
Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social support
Time Frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
Oslo Social Support Scale
|
Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
|
Depressive symptoms
Time Frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
Patient Health Questionnaire-9 (PHQ9)
|
Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
|
Workplace loneliness
Time Frame: Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
Specific scale regarding loneliness experienced at workplaces. Includes 5 items that are modified from the UCLA loneliness scale. It was validated in Finnish adult population. Please see Kemppinen and Tanskanen (2023) for full description: Kemppinen, S., Tanskanen, J., 2023. Suomenkielisen työyksinäisyysmittarin validointi etä- ja hybridityöläisillä (Eng title: Validation of Finnish loneliness at work scale with remote and hybrid worker sample). Psykologia 58, 198-219. |
Will be measured three times: baseline, 3-month follow-up and 6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity and behavior on the application
Time Frame: 6 months
|
Each individual user's activity on the mobile application will be measured.
The data will be used for additional analyses.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Siiri-Liisi Kraav, PhD, University of Eastern Finland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 240128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
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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