University of Oulu

Alonso-Solís A, Rubinstein K, Corripio I, et al. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST): a prospective multicentre feasibility study protocol in patients and their caregivers. BMJ Open 2018;8:e021346. doi:10.1136/bmjopen-2017-021346

Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST) : a prospective multicentre feasibility study protocol in patients and their caregivers

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Author: Alonso-Solís, Anna1,2; Rubinstein, Katya3; Corripio, Iluminada1,2;
Organizations: 1Department of Psychiatry, Biomedical Research Institute Sant Pau (IIB-SANT PAU), Hospital Santa Creu i Sant Pau; Universitat Autònoma de Barcelona (UAB)
2Mental Health Networking Biomedical Research Centre, CIBERSAM
3The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center
4Centre for Life Course Health Research, University of Oulu
5Department of Psychiatry, Oulu University Hospital
6Agency for Quality and Health Assessment of Catalonia (AQuAS), Health Ministry
7Department of Psychiatry and Psychotherapy, Semmelweis University
8Imec-SMIT, Vrije Universiteit Brussel
9Teaching, Research and Innovation Unit, Parc Sanitari Sant Joan de Deu (PSSJD)
10Research and Development, Imec vzw
11TicSalut Health Department, Generalitat de Catalunya
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.5 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2018110847666
Language: English
Published: BMJ, 2018
Publish Date: 2018-11-08
Description:

Abstract

Introduction: Treatment-resistant schizophrenia (TRS) is a severe form of schizophrenia. In the European Union, approximately 40% of people with schizophrenia have TRS. Factors such as the persistence of positive symptoms or higher risk of comorbidities leave clinicians with a complex scenario when treating these patients. Intervention strategies based on mHealth have demonstrated their ability to support and promote self-management-based strategies. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST), an innovative mHealth solution based on novel technology and offering high modular and flexible functioning, has been developed specifically for patients with TRS and their caregivers. As intervention in TRS is a challenge, it is necessary to perform a feasibility study before the cost-effectiveness testing stage.

Methods and analysis: This manuscript describes the protocol for a prospective multicentre feasibility study in 45 patients with TRS and their caregivers who will be attended in the public health system of three localities: Hospital Santa Creu Sant Pau (Spain), Semmelweis University (Hungary) and Gertner Institute & Sheba Medical Center (Israel). The primary aim is to investigate the feasibility and acceptability of the m-RESIST solution, configured by three mHealth tools: an app, wearable and a web-based platform. The solution collects data about acceptability, usability and satisfaction, together with preliminary data on perceived quality of life, symptoms and economic variables. The secondary aim is to collect preliminary data on perceived quality of life, symptoms and economic variables.

Ethics and dissemination: This study protocol, funded by the Horizon 2020 Programme of the European Union, has the approval of the ethics committees of the participating institutions. Participants will be fully informed of the purpose and procedures of the study, and signed inform consents will be obtained. The results will be published in peer-reviewed journals and presented in scientific conferences to ensure widespread dissemination.

Trial registration number: NCT03064776; Pre-results.

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Series: BMJ open
ISSN: 2044-6055
ISSN-E: 2044-6055
ISSN-L: 2044-6055
Volume: 8
Issue: 7
Article number: e021346
DOI: 10.1136/bmjopen-2017-021346
OADOI: https://oadoi.org/10.1136/bmjopen-2017-021346
Type of Publication: A1 Journal article – refereed
Field of Science: 3124 Neurology and psychiatry
Subjects:
Funding: This work has been supported by the Horizon 2020 Framework Programme of the European Union (grant number 643552) and partly funded by FEDER funds of the EU and CERCA Programme/Generalitat de Catalunya. Trial Sponsor: Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau–IIB Sant Pau, Spain.
Copyright information: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
  https://creativecommons.org/licenses/by-nc/4.0/