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

Abstract

IntroductionTreatment-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 analysisThis 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 disseminationThis 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 numberNCT03064776; Pre-results.

Mobile Phone and Wearable Sensor-Based mHealth Approaches for Psychiatric Disorders and Symptoms: Systematic Review

“…The functionality of the CDSS is based on the workflows developed by expert clinicians, reflecting the process of interaction between the system and its users in order to establish novel health care pathways. The CDSS activation is triggered by an event (ie, change in the baseline value) that is interpreted in a context of additional information that exists regarding a specific patient (ie, records in the patient’s file and information regarding attendance of scheduled visits) and a series of predefined conditions and actions [83].…”

“…The features supplied by sensor data that are used to trigger the CDSS are as follows: app number and duration of incoming, outgoing, and missed calls; number of incoming and outgoing SMS text messages by mobile phone; amount of time spent at home and in other places, measured by GPS data; and amount of time sleeping measured by physiological heart rate [83].…”

Wearables in Schizophrenia: Update on Current and Future Clinical Applications

“…Other platforms are being studied as well, such as Mobile Therapeutic Attention for Treatment-Resistant Schizophrenia (m-RESIST)-a project that is currently testing the feasibility of its platform, wearable, and smartphone app combination [12,30]. Likewise, the Sleepsight platform was used with wearable sleep and activity data from 15 people with schizophrenia living in their homes.…”

Pencegahan Kekambuhan Klien Skizofrenia Berbasis Mobile Apps dan Mobile Web: Systematic Review

“…(27) M-Resist menggunakan web based platform sebagai alat untuk mengumpulkan data klien, dan melakukan komunikasi dan koordinasi dengan klien dan petugas kesehatan lainnya. (30)…”