Study protocol of EMPOWER: A cluster randomised trial of a multimodal eHealth intervention for promoting mental health in the workplace following a stepped wedge trial design

Beatriz Olaya, Christina Van Der Feltz-Cornelis, Leona Hakkaart-Van Roijen, Dorota Merecz-Kot, Marjo Sinokki, Päivi Naumanen, Jessie Shepherd, Fréderique van Krugten, Marleen de Mul, Kaja Staszewska, Ellen Vorstenbosch, Carlota de Miquel, Rodrigo Antunes Lima, José Luis Ayuso-Mateos, Luis Salvador-Carulla, Oriol Borrega, Carla Sabariego, Renaldo M. Bernard, Christophe Vanroelen, Jessie GevaertKaren Van Aerden, Alberto Raggi, Francesco Seghezzi, Josep Maria Haro

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Objective: This article describes the EMPOWER study, a controlled trial aiming to determine the effectiveness and cost-effectiveness of an eHealth intervention to prevent common health problems and reduce presenteeism and absenteeism in the workplace.
Intervention: The EMPOWER intervention spans universal, secondary and tertiary prevention and consists of an eHealth platform delivered via a website and smartphone app designed to guide employees throughout different modules according to their specific profiles.
Design: A stepped-wedge cluster randomized trial will be implemented in four countries (Finland, Poland, Spain and UK) with employees from small and medium enterprises (SMEs) and public agencies. Companies will be randomly allocated in one of three groups with different times at which the intervention is implemented. The intervention will last 7weeks. Employees will answer several questionnaires at baseline, pre- and post-intervention and follow-up.
Outcome measures: The main outcome is presenteeism. Secondary outcomes include depression, anxiety, insomnia, stress levels, wellbeing and absenteeism. Analyses will be conducted at the individual level using the intention-to-treat approach and mixed models. Additional analyses will evaluate the intervention effects according to gender, country or type of company. Cost-effectiveness and cost-utility analyses [based on the use of quality-adjusted life-years (QALYS)] will consider a societal, employers’ and employees’ perspective.
Originele taal-2English
Pagina's (van-tot)1-16
Aantal pagina's16
TijdschriftDigital health legal (Online)
Volume8
DOI's
StatusPublished - okt 2022

Bibliografische nota

Funding Information:
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. CFC declares honoraries received for lectures from Lloyds Register Foundation and Janssen UK and holds grants from the British Medical Association, NIHR, and the European Union Horizon Program.

Funding Information:
To address these demands, we developed the EMPOWER platform, a multi-modal and integrative eHealth intervention aimed at reducing mental health problems in the workplace and improving employees’ wellbeing. EMPOWER was funded by the European Commission (EC), has been especially designed for SMEs and will undergo a rigorous evaluation of its effectiveness and cost-effectiveness in an RCT using stepped-wedge trial design (SWTD). The objective of this study protocol is to describe the RCT, which will be conducted in SMEs and public sector organizations in four countries: Finland, Poland, Spain and the United Kingdom (UK). These countries represent different European welfare and health service models: the Scandinavian model (Finland), characterized by protective and universal regimes in terms of welfare provision; the Mediterranean model (Spain), with a fragmented system of welfare provision, and strong reliance on family and charitable sector; the Eastern European model (Poland), with an underdeveloped welfare system but strong labour market institutions and solid industrial economy; and the Anglo–Saxon model (UK), based on a National Health Service (NHS) providing medical treatments to all at no cost, and a welfare system with high social stratification.

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Health and Medical Research Council of Australia (APP1195937) and the European Union Horizon 2020 Research and Innovation Programme Health (grant number APP1195937, 848180). BO is supported by the Miguel Servet (CP20/00040) contract, funded by the Instituto de Salud Carlos III (Spain) and co-funded by the European Union (ERDF/ESF, “Investing in your future”). C.M. has received funding in form of a pre-doctoral grant from the Generalitat de Catalunya (PIF-Salut grant, code SLT017/20/000138).

Publisher Copyright:
© The Author(s) 2022.

Copyright:
Copyright 2022 Elsevier B.V., All rights reserved.

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