Siiri-Liisi Kraav , Eric Schoenmakers , Ismo Linnosmaa , Samu Sorola , Tommi Tolmunen
{"title":"评估Frendie PRO移动应用程序在减少员工孤独感和社会隔离方面有效性的聚类随机试验研究方案。","authors":"Siiri-Liisi Kraav , Eric Schoenmakers , Ismo Linnosmaa , Samu Sorola , Tommi Tolmunen","doi":"10.1016/j.cct.2025.108060","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Dissatisfaction with interpersonal relationships in the workplace negatively impacts well-being and work performance. Almost 30 % of people of working age in Finland experience loneliness all or most of the time. Cost-effective methods are needed to improve the social well-being of the general working-age population. This cluster randomized trial aims to investigate whether a mobile application can improve employees' well-being and work-life relationships and reduce their experience of loneliness.</div></div><div><h3>Methods</h3><div>The current study aims to evaluate the effectiveness of the Frendie PRO mobile application on employees' social well-being measured by loneliness, workplace loneliness, work belongingness, and depressive symptoms as primary outcomes. A cluster randomized trial will be performed in workplaces. The intervention group will be given access to and is encouraged to use the Frendie PRO mobile application. The control group will have access to the application after the follow-up period. Data will be collected at three timepoints: baseline (before using the application), 3-month, and 6-month follow-up. The effectiveness and cost-effectiveness of the application will be analyzed.</div></div><div><h3>Discussion</h3><div>The intervention is hypothesized to reduce loneliness and workplace loneliness and increase the sense of work belongingness among employees. The study results may be used to develop the Frendie PRO mobile application further and develop other similar digital loneliness interventions for adults in the general population.</div><div><strong>Trial registration:</strong> The trial has been registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, registration number NCT06495801, date of registration 11. July 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108060"},"PeriodicalIF":1.9000,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation\",\"authors\":\"Siiri-Liisi Kraav , Eric Schoenmakers , Ismo Linnosmaa , Samu Sorola , Tommi Tolmunen\",\"doi\":\"10.1016/j.cct.2025.108060\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Dissatisfaction with interpersonal relationships in the workplace negatively impacts well-being and work performance. Almost 30 % of people of working age in Finland experience loneliness all or most of the time. Cost-effective methods are needed to improve the social well-being of the general working-age population. This cluster randomized trial aims to investigate whether a mobile application can improve employees' well-being and work-life relationships and reduce their experience of loneliness.</div></div><div><h3>Methods</h3><div>The current study aims to evaluate the effectiveness of the Frendie PRO mobile application on employees' social well-being measured by loneliness, workplace loneliness, work belongingness, and depressive symptoms as primary outcomes. A cluster randomized trial will be performed in workplaces. The intervention group will be given access to and is encouraged to use the Frendie PRO mobile application. The control group will have access to the application after the follow-up period. Data will be collected at three timepoints: baseline (before using the application), 3-month, and 6-month follow-up. The effectiveness and cost-effectiveness of the application will be analyzed.</div></div><div><h3>Discussion</h3><div>The intervention is hypothesized to reduce loneliness and workplace loneliness and increase the sense of work belongingness among employees. The study results may be used to develop the Frendie PRO mobile application further and develop other similar digital loneliness interventions for adults in the general population.</div><div><strong>Trial registration:</strong> The trial has been registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, registration number NCT06495801, date of registration 11. July 2024.</div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"157 \",\"pages\":\"Article 108060\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-08-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S155171442500254X\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S155171442500254X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation
Background
Dissatisfaction with interpersonal relationships in the workplace negatively impacts well-being and work performance. Almost 30 % of people of working age in Finland experience loneliness all or most of the time. Cost-effective methods are needed to improve the social well-being of the general working-age population. This cluster randomized trial aims to investigate whether a mobile application can improve employees' well-being and work-life relationships and reduce their experience of loneliness.
Methods
The current study aims to evaluate the effectiveness of the Frendie PRO mobile application on employees' social well-being measured by loneliness, workplace loneliness, work belongingness, and depressive symptoms as primary outcomes. A cluster randomized trial will be performed in workplaces. The intervention group will be given access to and is encouraged to use the Frendie PRO mobile application. The control group will have access to the application after the follow-up period. Data will be collected at three timepoints: baseline (before using the application), 3-month, and 6-month follow-up. The effectiveness and cost-effectiveness of the application will be analyzed.
Discussion
The intervention is hypothesized to reduce loneliness and workplace loneliness and increase the sense of work belongingness among employees. The study results may be used to develop the Frendie PRO mobile application further and develop other similar digital loneliness interventions for adults in the general population.
Trial registration: The trial has been registered at ClinicalTrials.gov, registration number NCT06495801, date of registration 11. July 2024.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.