NCT06495801

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

July 2, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

lonelinesswork well-beingsocial well-being

Outcome Measures

Primary Outcomes (2)

  • Loneliness

    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

    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: * family members who live elsewhere * friends * colleagues or fellow students at the workplace/school and outside of the workplace/school * neighbors and local community * people from social clubs, hobby groups, and religious organisations at and outside the meetings.

    Will be measured three times: baseline, 3-month follow-up and 6-month follow-up

Secondary Outcomes (3)

  • Social support

    Will be measured three times: baseline, 3-month follow-up and 6-month follow-up

  • Depressive symptoms

    Will be measured three times: baseline, 3-month follow-up and 6-month follow-up

  • Workplace loneliness

    Will be measured three times: baseline, 3-month follow-up and 6-month follow-up

Other Outcomes (1)

  • Activity and behavior on the application

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Frendie PRO mobile application

Wait-list controls

NO INTERVENTION

The group will have access to the mobile application after the six-month follow-up period.

Interventions

Frendie PRO mobile application offers employees an environment to manage their social relationships, organize leisure activities, and discuss personal or work-related matters.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • incapable of using questionnaire online
  • does not know Finnish well enough to answer the questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, North Savonia, 70110, Finland

Location

Related Publications (1)

  • Kraav SL, Schoenmakers E, Linnosmaa I, Sorola S, Tolmunen T. Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation. Contemp Clin Trials. 2025 Oct;157:108060. doi: 10.1016/j.cct.2025.108060. Epub 2025 Aug 28.

MeSH Terms

Conditions

Social IsolationDepression

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Siiri-Liisi Kraav, PhD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The baseline data collection is conducted before randomization. No masking will be used after the randomization.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants of the intervention group are given access and encouraged to use Frendie PRO mobile application
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 11, 2024

Study Start

September 20, 2024

Primary Completion

May 20, 2025

Study Completion

August 1, 2025

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

After 10 years, anonymized data will be offered to the Finnish Social Science Data Archive. If the data will not be accepted there, it will be destroyed.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After 10 years.
Access Criteria
Application to the Finnish Social Science Data Archive
More information

Locations