Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): m-RESIST Patients; m-RESIST Caregivers
Intervention type(s): Device; Device
Intervention description(s): A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers; A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: telemedicine