A Study Protocol for Development and Validation of a Clinical Prediction Model for Frailty (ModulEn): a new European Commitment to Tackling Frailty

Abstract

There is a growing need to implement and evaluate the technological solutions that allow the early detection of age-related frailty and enable assessment of the predictive values of frailty components. The broad use of these solutions may ensure an efficient and sustainable response of health and social care systems to the challenges related to demographic aging. In this paper, we present the protocol of the ModulEn study that aims to develop and validate a predictive model for frailty. For this purpose, the sample composed by older adults aged 65-80 years and recruited from the community will be invited to use an electronic device ACM Kronowise® 2.0. This device allows proactive and continuous monitoring of circadian health, physical activity, and sleep and eating habits. It will be used during a period of seven to ten days. The participants will also be given the questionnaires evaluating the variables of interest, including frailty level, as well as their experience and satisfaction with the device use. Data provided from these two sources will be combined and the relevant associations will be identified. In our view, the implications of this study' findings for clinical practice include the possibility to develop and validate tools for timely prevention of frailty progress. In the long term, the ModulEn may contribute to the critical reduction of frailty burden in Europe.