Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia

m-RESIST is an m-health intervention program aimed to develop, test and evaluate a tool to allow patients suffering from treatment-resistant schizophrenia to self-manage their condition. This may facilitate acceptance and involvement of patients with their own treatment, as well as of caregivers. Moreover this programme could provide a new tool to the psychiatrist, psychologists working together with other health care professionals, to better monitor patients, through a personalised and optimised therapeutic process. The present document corresponds to the pilot field-trials phase included in a three year European research project, co-funded by the Horizon 2020 Framework Programme of the European Union (grant agreement nº 643552). This document summarises the protocol of the whole therapeutic process, specifying all the procedures included in the program. This protocol will be implemented in three countries: Israel, Hungary and Spain, in order to test acceptability, usability, satisfaction and changes in the quality of life reported by the end-users.

The main goal of the present study is to evaluate the acceptability, usability, and satisfaction to m-RESIST solution among the target groups (patients, caregivers, clinicians), and also to evaluate the effect of m-RESIST solution to empowerment and perceived quality of life of the treatment-resistant Schizophrenia patients (TRS). Interventions targeting key problems in TRS (risk behaviours, persistent symptoms of psychosis, poor medication adherence, unhealthy lifestyle habits) will be administered in a clinical setting, with the long-term goal of creating a widely-available system that can be deployed by users as needed, in their own environments. The study will be conducted in three different regions: Gertner (Israel), Semmelweis (Hungary) and Barcelona (Spain). Consequently, the outcomes obtained in each site and their comparison will allow improving the m-RESIST program in terms of interoperability, integration of components and final implementation of the interactive system in the healthcare pathways. The participants will be selected from Sheba Medical Center - Psychiatric Division (Tel Aviv), Semmelweis University - Department of Psychiatry and Psychotherapy (Budapest), and the adult psychiatric outpatient service of Hospital de la Santa Creu i Sant Pau (Barcelona). A total of 45 patients with TRS (15 per centre), with their caregiver, will be included in the trial. All participants will be fully informed about the nature of the study (aims, methodology) and the system tested (data protection, expected risks/benefits, possible adverse events) and they will sign the informed consent for their participation in this study.