‘Value-based methodology for person-centred, integrated care supported by Information and Communication Technologies’ (ValueCare) for older people in Europe: study protocol for a pre-post controlled trial
Authors: Bally E. L. S. , van Grieken A. , Ye L. , Ferrando M. , Fernández-Salido M. , Dix R. , Zanutto O. , Gallucci M. , Vasiljev V. , Carroll A. , Darley A. , Gil-Salmerón A. , Ortet S. , Rentoumis T. , Kavoulis N. , Mayora-Ibarra O. , Karanasiou N. , Koutalieris G. , Hazelzet J. A. , Roozenbeek B. , Dippel D. W. J. , Raat H. ,   on behalf of the ValueCare consortium, Brouwer Dorien , Mattace-Raso Francesco , Cheng Demi , Ferri Mireia , Alhambra-Borrás Tamara , Garcés-Ferrer Jorge , Acha Beatriz Vallina , Rocher Elena , Macchione Stefania , Procaccini Elena , Rukavina Tomislav , Harnett Patrick , Machado Natália , Guardado Diana , Leandro Ana Filipa , Marchesoni Michele , Eccher Claudio , Testa Sara , Arkoumanis Ioannis , Koumparos Athanasios , Tram Nhu , Lewis Leo , Peiró Pilar Gangas , Allegretti Natalia , Mackiewicz Karolina 
Published: August 2022

Abstract
Background
Older people receive care from multiple providers which often results in a lack of coordination. The Information and Communication Technology (ICT) enabled value-based methodology for integrated care (ValueCare) project aims to develop and implement efficient outcome-based, integrated health and social care for older people with multimorbidity, and/or frailty, and/or mild to moderate cognitive impairment in seven sites (Athens, Greece; Coimbra, Portugal; Cork/Kerry, Ireland; Rijeka, Croatia; Rotterdam, the Netherlands; Treviso, Italy; and Valencia, Spain). We will evaluate the implementation and the outcomes of the ValueCare approach. This paper presents the study protocol of the ValueCare project; a protocol for a pre-post controlled study in seven large-scale sites in Europe over the period between 2021 and 2023.

Methods
A pre-post controlled study design including three time points (baseline, post-intervention after 12 months, and follow-up after 18 months) and two groups (intervention and control group) will be utilised. In each site, (net) 240 older people (120 in the intervention group and 120 in the control group), 50–70 informal caregivers (e.g. relatives, friends), and 30–40 health and social care practitioners will be invited to participate and provide informed consent. Self-reported outcomes will be measured in multiple domains; for older people: health, wellbeing, quality of life, lifestyle behaviour, and health and social care use; for informal caregivers and health and social care practitioners: wellbeing, perceived burden and (job) satisfaction. In addition, implementation outcomes will be measured in terms of acceptability, appropriateness, feasibility, fidelity, and costs. To evaluate differences in outcomes between the intervention and control group (multilevel) logistic and linear regression analyses will be used. Qualitative analysis will be performed on the focus group data.

Discussion
This study will provide new insights into the feasibility and effectiveness of a value-based methodology for integrated care supported by ICT for older people, their informal caregivers, and health and social care practitioners in seven different European settings.

Trial registration
ISRCTN registry number is 25089186. Date of trial registration is 16/11/2021.