Community Research and Development Information Service - CORDIS


m-RESIST Report Summary

Project ID: 643552
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - m-RESIST (Mobile Therapeutic Attention for Patients with Treatment Resistant Schizophrenia)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

Approximately 5 million people in the European Union suffer from psychotic disorders. The largest group among them is that of schizophrenic patients, of which between 30-50% can be considered resistant to treatment. Standard intervention in patients with treatment resistant schizophrenia (TRS) is complex: i.e. presence of persistent positive symptomatology, extensive periods of hospital care, and greater risk of multi-morbidity. This scenario generates a significant degree of suffering for the patients, family and social environment, as well as significant costs for the healthcare system.
Up to date, standard treatment has not proven to be sufficient to achieve remission in resistant schizophrenic patients. Therefore, an improved understanding of TRS and the development of innovative evidence-based interventions adjunctive to pharmacological and psychosocial treatment are necessary.

Intervention strategies based on m-Health have demonstrated their ability to support and promote self-management-based strategies. In the case of TRS patients, an intervention programme based on m-Health offers a holistic approach that: i) integrates psychiatric and psychological assistance with other medical health-carers; ii) better monitors patients with resistant schizophrenia through a personalised and optimised therapeutic process; iii) promotes acceptance and self-management of the disease and its co-morbidities; and iv) encourages the involvement of patients and their caregivers in the therapeutic process.
Therefore, the current project aims to develop an innovative disease management solution, m-RESIST, based on a mobile ICT system and intervention programme addressed to empower TRS patients. The solution (system + intervention programme) will actively involve patients in the therapeutic process and will enable them to self-manage their condition. Moreover, m-RESIST is expected to become a step forward in improving and optimizing the clinical decision process.

Thus, the specific objectives of the m-RESIST Project are:
a. Design and develop the m-RESIST system.
b. Design the m-RESIST programme (services, care pathways or health routes)
c. Test the m-RESIST system and programme on healthy volunteers and TRS patients.
d. Promote an active role of TRS patients and caregivers in the design of the m-RESIST programme and system, through the implementation of a concise users’ needs identification process.
e. Promote an active role of patients and caregivers in the development and improvement of the m-RESIST programme and system.
i. At the start of the project: by collecting patients and caregiver based information on improvement parameters (i.e. “What does being better mean for you/ for your relative?”).
ii. Throughout the project: by assessing the acceptability of m-RESIST interfaces in terms of usability, accessibility, satisfaction, and perceived usefulness and appropriateness. The project will also identify dissonances between end-users' needs and m-RESIST responses to them, as well as dissonances in treatment effectiveness parameters. The solution will be regularly readjusted based on the patients and caregivers' suggestions.
f. To create a predictive model based on the data gathered by the system in order to identify risks and gaps in the clinical and medical treatments which will enable the prescription of personalised interventions.

The achievement of these specific aims will demonstrate the good perception and usability of the solution and will pave the way for a follow-up process to assess the effectiveness and efficiency of the m-RESIST system, in achieving clinical, psychological, social and economic benefits.

The m-RESIST solution will be designed following a mirror approach whereby each patient acts as his own control, and outcomes are assessed and compared before and after the suggested intervention. The m-RESIST solution includes the following modules:
A. Mobile monitoring subsystem: this module provides patients with information and tools allowing them to control and self-manage their illness and will facilitate the monitoring of patients’ adherence to medication.
B. Subsystem of information and communication to the patient and caregiver (landline and mobile): the function of this subsystem is to inform and train the patient in a personalised manner, covering different areas that may help to improve their quality of life: healthy lifestyle, well-being, mental health, prevention and self-care.
C. Subsystem of intervention: the subsystem of therapeutic interventions includes psychiatric and psychological visits programmed online; mobile App messaging interventions incorporating CBT-p techniques for resistant schizophrenia.
D. Subsystem of medical-psychological assessment module: this subsystem will evaluate the state of the patient from a clinical viewpoint, regarding subjective well-being and side-effects, and will include CBTp intervention and alert management.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Throughout the first reporting period the consortium has conducted all horizontal tasks required for the appropriate management and coordination of the project and to ensure the effective coordination between all partners. The tasks performed in the first reporting included consortium, administrative and financial management (T1.1/D1.1)) and Quality management (T1.2/D1.2)
Thanks to the work carried out during this reporting period the consortium has provided a consolidated work and management plan and has set up the internal communication structures to guarantee the fluent communication between partners. These structures have allowed identifying conflicting issues, setting up mitigation measures, arrange planned and unplanned meetings and monitoring a time and quality-compliant achievement and submission of the deliverables.

Quality standards have been monitored and guaranteed by means of a clearly defined operational management and coordination structures, allowing all partners to fulfill their tasks and comply with the quality requirements of the project.

Moreover, the consortium subcontracted the services of one Legal Consultancy Firm in order to ensure that the consortium fulfil all the legal requirements in the different steps of the project including ethics, security and all legal European and national legislation. The setting up of this monitoring process will guarantee the ethical and security compliance of all project actions and deliverables.
A risk management strategy has also been part of the activities conducted in terms of management and coordination and has allowed the consortium to deal with operational, communication, scientific and technical deviations observed during the first reporting period.

Based on the above, the work plan has been updated and changes notified to all project partners and the managing authority to ensure its implementation.

The operational activities of the project started by describing the needs, wants and preferences of the system’ users and how they would be anticipated by m-RESIST service (WP2).

First, the consortium described an ethical road map (T2.1/D2.1) guiding the legal and ethical requirements that would guide the m-RESIST solution and the project development in the three countries conducting the pilot tests. The roadmap has the purpose to guarantee that all ethical and legal requirements are translated into the solution definition. In parallel, an analysis of the end user needs (T2.2/ D2.2), requirements and preferences of the m-RESIST users (patients, family members and personal caregivers) was conducted by using a focus group and interview-based methodology. The two previous actions made possible for the consortium to describe innovative healthcare routes (T2.3 /D2.3 – 2.4) that will be generated and facilitated by the m-RESIST solution and to define, accordingly, its functional and non-functional requirements.
As a result of these actions the consortium was able to identify the norms and protocols that would be guiding the pilot process, the use of ICT in healthcare environments and establishing a comparison between different legislation and regulations (T2.1). The analysis of end user needs provided information in the current weaknesses and strengths of ICT systems for the management of treatment resistant schizophrenia, the users’ attitudes, perception and concerns towards the m-resist system (T2.2). All this, resulted in the definition of innovative care pathways facilitated by the m-RESIST programme and intervention modules (T2.3) and the definition of the system functional and non-functional requirements and components (T2.3)

The previous requirements and definition paved the way for the design and development of the m-RESIST system. A first step consisted in the translation of the previous users’ needs and requirements into three design documents describing the system (front-end design, back-end design and integration layer design (T3.1/D3.1, T3.3/D3.3 and T3.5/D3.5). The results of these actions included an initial, structured description of the specific clinical interventions that would be subsequently translated into the digital platform. Subsequently, the first development cycles have started (T3.2/D3.2, T3.4/D3.4 and T3.6/D3.6). At this stage the platform starts to be built iteratively, using a continuous loop from users, at every iteration.

The piloting activies have also begun, aimed to test the m-RESIST program pilot in patients suffering refractory schizophrenia. Within this period, tasks for pilot definition (T5.1) and pilot administrative, legal and ethics procedures (T5.2) have started. No deliverables produced within the first reporting period.

Dissemination and communication activities (T7.1 and T7.3) have been conducted transversally throughout the first reporting period. For this the consortium has defined a communication plan (D7.2) covering all important targets and channels, including the project website (D7.1). All these activities have resulted in the deployment and continuous update of the project website, the production of 3 press releases, 1 newsletter and 4 articles, the presentation of the m-RESIST project in 5 relevant conferences and workshops, the production of a first set of promotional material, the recording of two videos and the liaison with 3 external initiatives.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

As set out in the Project DoA, m-RESIST aims to provide an innovative solution for the self-management and attention to treatment resistant patients. The solution is composed by two elements, the m-RESIST System, that includes all technical components, and the m-RESIST Programme, that sets the basis for the clinical intervention pathways. During the first reporting period, the consortium has actively worked in the definition of the latter, the m-RESIST Programme, and has set the basis for the development of the m-RESIST system (to be completed during the second reporting period).

The m-RESIST Programme represents a new model for TRS attention and self-management, and goes far beyond existing healthcare processes and models. The m-RESIST programme offers new possibilities for the continuity of care, immediate attention, prevention and self-management of the disease, offering, at all times, the possibility to orientate attention in a more patient centric model.

The innovative and disruptive nature of the m-RESIST Programme, so far designed, has been guaranteed by the active involvement of TRS patients, caregivers and professionals providing their insights, perceptions, concerns and expectations during the definition of the programme. These needs have been analysed and identified in a wider environment taking into consideration, at all times, the self-management needs of the patients and caregivers.

The analysis and assessment of the previous needs and expectations has been translated into the m-RESIST programme seeking to provide a specific answer to all the inputs received from the uses. The result is an innovative model that allows for an improved self-management of the disease, guarantees a regular interaction between the patients and the caregivers / professionals, ensures the continuity of assistance and facilitates the response to patient-specific demands.

Together with the above, m-RESIST can be seen as a valuable solution to overcome the inability of standard programmes to adapt to the end-user profile: schizophrenia resistant patients characterised by the presence of marked clinical features. Positive resistant symptoms typically prevent the performance of everyday tasks, disrupting daily functioning, together with social difficulties (isolation) and poor insight, difficult engagement and poor compliance with medical procedures or care regimen.

The model provided by the m-RESIST system and programme represents a step beyond the interventions analysed and identified throughout the field analysis process by bringing together in a same intervention area the following elements (represented by the different modules of the system), namely a) patient and caregiver monitoring module, b) treatment administration dashboard, c) medical-psychological assessment, d) remote intervention module, e) personalised intervention and f) schizophrenia information module.

The interest shown by the target users on the m-RESIST system and programme throughout the user’ needs identification process, anticipates the need for patients empowerment, and show the innovative perception of the tool in actively engaging patients and caregivers in the therapeutic process. Using some of the users’ words, the programme has been very well regarded thanks to its novelty, its personalised response and flexibility. m-RESIST realised that each user group perceived the solution from a different perspective and valued specific aspects above others (thus, caregivers saw the possibility to play a more active role in treatment, clinicians were interested in a programme that reduces their burden at the same time that increases contact with patients, and patients saw their autonomy and empowerment as paramount).
It is critical to stress, again, that the m-RESIST is not a mobile based service within the existing system of services. It consists in a new programme that will trigger the profound reorganisation of the current care pathways as well as the clinical processes -inclusion, intervention, follow-up and discharge-, and the role of the common clinical actors involved -psychiatrist, psychologist, case manager, nurse -.
Regarding the m-RESIST system (technical / technological components), the inability to integrate technology that enables more efficient and responsive information exchange has been common. The design of the m-RESIST system aims to fulfill this gap by following the principles of novel technology, high modularity and flexibility, and personalized response to heterogenic needs. Overcoming the disadvantages of the current healthcare system, m-RESIST system design provides continuity of care, immediate attention for prevention of relapse and repeated hospitalizations, automated and personalised interventions for improvement of treatment adherence and motivation for healthy lifestyle, as well as easy and efficient communication between the system users.

The system guarantees its usability by interacting with the users through personalized dashboards, tailored for different user roles, and process actively and passively obtained data from several sources, such as user reports, existing medical records, sensors, and supplementary devices and databases. The system design allows, also, performing several core functions, such as clinical assessment and monitoring, online and offline communication, as well as provide personalized information and interventions. The data entered into the system will be stored, classified and processed within the “smart” internal system components, such as recommender system, providing personally-tailored treatment recommendation for patients, and clinical decision support systems, assisting the clinicians to make clinical decisions and provide quick and focused interventions.

In order to ensure the impact of the project, the design phase has placed significant attention to establishing interoperability and interfaces between m-RESIST and existing medical records in different countries and health institutions, creating a user friendly and engaging virtual environment that includes variety of appealing content and that is “not just about the illness”.

Finally, thanks to the specific attention that the project has invested so far on the ethical and legal factors surrounding the implementation of ICT tools for treatment resistant schizophrenia the project has re-examined the current legal and ethical frameworks and has ensured that the system and programme comply with the most recent ethical and legal arrangements (all of them included in D2.2 Ethical Roadmap).

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