m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study.

BACKGROUND: In the European Union, around 5 million people are affected by psychotic disorders, and approximately 30%-50% of people with schizophrenia have treatment-resistant schizophrenia (TRS). Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. People with schizophrenia seem willing and able to use smartphones to monitor their symptoms and engage in therapeutic interventions. mHealth studies have been performed with other clinical populations but not in populations with TRS. OBJECTIVE: The purpose of this study was to present the 3-month prospective results of the m-RESIST intervention. This study aims to assess the feasibility, acceptability, and usability of the m-RESIST intervention and the satisfaction among patients with TRS after using this intervention. METHODS: A prospective multicenter feasibility study without a control group was undertaken with patients with TRS. This study was performed at 3 sites: Sant Pau Hospital (Barcelona, Spain), Semmelweis University (Budapest, Hungary), and Sheba Medical Center and Gertner Institute of Epidemiology and Health Policy Research (Ramat-Gan, Israel). The m-RESIST intervention consisted of a smartwatch, a mobile app, a web-based platform, and a tailored therapeutic program. The m-RESIST intervention was delivered to patients with TRS and assisted by mental health care providers (psychiatrists and psychologists). Feasibility, usability, acceptability, and user satisfaction were measured. RESULTS: This study was performed with 39 patients with TRS. The dropout rate was 18% (7/39), the main reasons being as follows: loss to follow-up, clinical worsening, physical discomfort of the smartwatch, and social stigma. Patients' acceptance of m-RESIST ranged from moderate to high. The m-RESIST intervention could provide better control of the illness and appropriate care, together with offering user-friendly and easy-to-use technology. In terms of user experience, patients indicated that m-RESIST enabled easier and quicker communication with clinicians and made them feel more protected and safer. Patients' satisfaction was generally good: 78% (25/32) considered the quality of service as good or excellent, 84% (27/32) reported that they would use it again, and 94% (30/32) reported that they were mostly satisfied. CONCLUSIONS: The m-RESIST project has provided the basis for a new modular program based on novel technology: the m-RESIST intervention. This program was well-accepted by patients in terms of acceptability, usability, and satisfaction. Our results offer an encouraging starting point regarding mHealth technologies for patients with TRS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-021346.

A Method to Compare the Delivery of Psychiatric Care for People with Treatment-Resistant Schizophrenia.

INTRODUCTION: Community services are gaining ground when it comes to attention to patients with psychiatric diseases. Regarding patients with treatment-resistant schizophrenia (TRS), the use of information and communication technology (ICT) could help to shift the focus from hospital-centered attention to community services. This study compares the differences in mental health services provided for patients with TRS in Budapest (Hungary), Tel-Aviv (Israel) and Catalonia (Spain) by means of a method for the quick appraisal of gaps among the three places, for a potential implementation of the same ICT tool in these regions. METHODS: An adapted version of the Description and Standardised Evaluation of Services and Directories in Europe for Long Term Care (DESDE-LTC) instrument was made by researchers in Semmelweis University (Budapest, Hungary), Gertner Institute (Tel-Aviv, Israel) and Hospital de la Santa Creu I Sant Pau and Parc Sanitari Sant Joan de Déu (Catalonia, Spain). RESULTS: Two types of outpatient care services were available in the three regions. Only one type of day-care facility was common in the whole study area. Two residential care services, one for acute and the other for non-acute patients were available in every region. Finally, two self-care and volunteer-care facilities were available in the three places. CONCLUSION: Although the availability of services was different in each region, most of the services provided were sufficiently similar to allow the implementation of the same ICT solution in the three places.

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

BACKGROUND: Mobile Therapeutic Attention for Patients with Treatment-Resistant Schizophrenia (m-RESIST) is an EU Horizon 2020-funded project aimed at designing and validating an innovative therapeutic program for treatment-resistant schizophrenia. The program exploits information from mobile phones and wearable sensors for behavioral tracking to support intervention administration. OBJECTIVE: To systematically review original studies on sensor-based mHealth apps aimed at uncovering associations between sensor data and symptoms of psychiatric disorders in order to support the m-RESIST approach to assess effectiveness of behavioral monitoring in therapy. METHODS: A systematic review of the English-language literature, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, was performed through Scopus, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials databases. Studies published between September 1, 2009, and September 30, 2018, were selected. Boolean search operators with an iterative combination of search terms were applied. RESULTS: Studies reporting quantitative information on data collected from mobile use and/or wearable sensors, and where that information was associated with clinical outcomes, were included. A total of 35 studies were identified; most of them investigated bipolar disorders, depression, depression symptoms, stress, and symptoms of stress, while only a few studies addressed persons with schizophrenia. The data from sensors were associated with symptoms of schizophrenia, bipolar disorders, and depression. CONCLUSIONS: Although the data from sensors demonstrated an association with the symptoms of schizophrenia, bipolar disorders, and depression, their usability in clinical settings to support therapeutic intervention is not yet fully assessed and needs to be scrutinized more thoroughly.

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

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.

m-RESIST, a complete m-Health solution for patients with treatmentresistant schizophrenia: a qualitative study of user needs and acceptability in the Barcelona metropolitan area.

BACKGROUND: Despite the theoretical potential of m-health solutions in the treatment of patients with schizophrenia, there remains a lack of technological solutions in daily practice. The aim of this study was to measure the receptivity of patients, informal carers, and clinicians to an integral intervention model focused on patients with persistent positive symptoms: Mobile Therapeutic Attention for Patients with Treatment Resistant Schizophrenia (m-RESIST). METHODS: A qualitative study of the needs and acceptability of outpatients with treatment-resistant schizophrenia was carried out in Parc Sanitari Sant Joan de Déu (Barcelona). We analyzed the opinions of patients, informal carers, and clinicians concerning the services initially thought to be part of the solution. Five focus groups and eight interviews were carried out, using discourse analysis as the analytical approach. RESULTS: A webpage and a virtual forum were perceived as suitable to get reliable information on both the disease and support. Data transmission service, online visits, and instant messages were evaluated as ways to improve contact with clinicians. Alerts were appreciated as reminders of daily tasks and medical appointments. Avoiding stressful situations for outpatients, promoting an active role in the management of the disease, and maintaining human contact with clinicians were the main suggestions for improving the effectiveness of the solution. CONCLUSIONS: Positive acceptance of m-RESIST services is related to its usefulness in meeting user needs, its capacity to empower them, and the possibility of maintaining human contact.

m-RESIST, una solución m-Health integral para personas con Esquizofrenia Resistente: estudio cualitativo de necesidades y aceptabilidad de usuarios en el área de Barcelona / m-RESIST, a complete m-Health solution for patients with treatment-resistant schizophrenia: a qualitative study of user needs and acceptability in the Barcelona metropolitan area

Introducción. A pesar del creciente potencial teórico de las soluciones m-Health en el tratamiento de pacientes con esquizofrenia, siguen faltando soluciones tecnológicas a nivel práctico. El objetivo de este estudio fue medir las necesidades y aceptabilidad de pacientes, familiares y profesionales hacia un modelo m-Health de intervención integral: Salud Móvil para pacientes con esquizofrenia resistente al tratamiento (m-RESIST). Métodos. Se llevó a cabo un estudio cualitativo en el Parc Sanitari Sant Joan de Déu (Barcelona) de las necesidades y aceptabilidad de pacientes con esquizofrenia resistente. Se analizaron sus opiniones, junto con las de familiares y profesionales, relativas a los servicios inicialmente pensados para formar parte del m-RESIST. Se realizaron cinco grupos focales y ocho entrevistas, usando el análisis del discurso como aproximación analítica. Resultados. Se consideró adecuada la creación de una página web y un foro virtual para obtener información fiable sobre la enfermedad y como apoyo entre usuarios. Para mejorar el contacto con los profesionales, se valoró positivamente el servicio de transmisión de datos, visitas "online" y mensajes instantáneos. Las alertas fueron consideradas útiles como recordatorios de tareas diarias y citas médicas. Las principales sugerencias para mejorar la eficacia fueron: evitar el exceso de alertas para no generar estrés, promover un papel activo del paciente en el manejo de la enfermedad y mantener contacto personal con los profesionales. Conclusiones. La buena aceptabilidad hacia el m-RESIST se relaciona con su utilidad para satisfacer las necesidades del usuario, su capacidad para empoderarles y la posibilidad de mantener contacto humano (AU)

Background. Despite the theoretical potential of m-health solutions in the treatment of patients with schizophrenia, there remains a lack of technological solutions in daily practice. The aim of this study was to measure the receptivity of patients, informal carers, and clinicians to an integral intervention model focused on patients with persistent positive symptoms: Mobile Therapeutic Attention for Patients with Treatment Resistant Schizophrenia (m-RESIST). Methods. A qualitative study of the needs and acceptability of outpatients with treatment-resistant schizophrenia was carried out in Parc Sanitari Sant Joan de Déu (Barcelona). We analyzed the opinions of patients, informal carers, and clinicians concerning the services initially thought to be part of the solution. Five focus groups and eight interviews were carried out, using discourse analysis as the analytical approach. Results. A webpage and a virtual forum were perceived as suitable to get reliable information on both the disease and support. Data transmission service, online visits, and instant messages were evaluated as ways to improve contact with clinicians. Alerts were appreciated as reminders of daily tasks and medical appointments. Avoiding stressful situations for outpatients, promoting an active role in the management of the disease, and maintaining human contact with clinicians were the main suggestions for improving the effectiveness of the solution. Conclusions. Positive acceptance of m-RESIST services is related to its usefulness in meeting user needs, its capacity to empower them, and the possibility of maintaining human contact (AU)

Measuring Users' Receptivity Toward an Integral Intervention Model Based on mHealth Solutions for Patients With Treatment-Resistant Schizophrenia (m-RESIST): A Qualitative Study.

BACKGROUND: Despite the theoretical potential of mHealth solutions in the treatment of patients with schizophrenia, there remains a lack of technological tools in clinical practice. OBJECTIVE: The aim of this study was to measure the receptivity of patients, informal carers, and clinicians to a European integral intervention model focused on patients with persistent positive symptoms: Mobile Therapeutic Attention for Patients with Treatment-Resistant Schizophrenia (m-RESIST). METHODS: Before defining the system requirements, a qualitative study of the needs of outpatients with treatment-resistant schizophrenia was carried out in Spain, Israel, and Hungary. We analyzed the opinions of patients, informal carers, and clinicians concerning the services originally intended to be part of the solution. A total of 9 focus groups (72 people) and 35 individual interviews were carried out in the 3 countries, using discourse analysis as the framework. RESULTS: A webpage and an online forum were perceived as suitable to get both reliable information on the disease and support. Data transmission by a smart watch (monitoring), Web-based visits, and instant messages (clinical treatment) were valued as ways to improve contact with clinicians. Alerts were appreciated as reminders of daily tasks and appointments. Avoiding stressful situations for outpatients, promoting an active role in the management of the disease, and maintaining human contact with clinicians were the main suggestions provided for improving the effectiveness of the solution. CONCLUSIONS: Positive receptivity toward m-RESIST services is related to its usefulness in meeting user needs, its capacity to empower them, and the possibility of maintaining human contact.