Back to results

Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia (m-RESIST)

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

m-RESIST Patients

m-RESIST Caregivers

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring telemedicine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Schizophrenia following the diagnostic and statistical manual of mental disorders (DSM-V) criteria.
Meet criteria for "treatment-resistant schizophrenia", term referred to two different subgroups of patients:
- Patients with schizophrenia who are refractory despite receiving antipsychotic treatment in suitable doses and duration (at least two dopamine D2 receptors antagonist antipsychotics, or on-going treatment with clozapine due to meeting treatment-resistant criteria), and presenting good adherence to treatment (Peuskens, 1999).
- Patients who may be considered pseudo-resistant to the treatment or resistance-like (Elkis & Meltzer, 2007). In this case, presence of active symptoms may be influenced by psychiatric and medical conditions such as poor insight, negative attitude to medication, social isolation, consumption of toxic substances, presence of nutritional and medical problems, inappropriate health habits, as well as poor alliance and/or environment conditions (low involvement of caregivers in the therapeutic process), which may substantially contribute to poor responses or insufficient effects of medication.
Duration of disease less than 15 years.
Used to Information and Communication Technologies (ICT) and having the physical capability to use them (determined using the Technological Readiness Questionnaire).
Presence of a informal caregiver -family members or significant others- of patients with treatment-resistant schizophrenia.

Exclusion Criteria:

Meet criteria for remission according to the Remission of Schizophrenia Working Group (Andreasen et al., 2005.)
The presence of delusions mainly related with their therapists or with new technologies.
Hearing, vision, or motor impairment that makes it impossible to operate a smartphone.
Presence of a caregiver or Informal carer not used to ICT or physical incapability to use them (determined using the Technological Readiness Questionnaire).
Presence of intellectual developmental disability.-

Sites / Locations

3Department of Psychiatry and Psychotherapy, Semmelweis University
The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center
Department of Psychiatry. Hospital Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

m-RESIST Patients

m-RESIST Caregivers

Arm Description

m-RESIST is a system designed to improve illness self-management and facilitate recovery in individuals with Treatment-resistant schizophrenia (TRS). The system will be used to Continuously capture multidimensional behaviour as it occurs in real-time and in real-world environments, using continuous collection and analysis of sensor data. Detect individual early warning signs, and trigger targeted interventions that may mitigate the severity of worsening or prevent their recurrence altogether, using the clinical decision support system (CDSS) and Recommender operation. The m-RESIST will deliver both system initiated (i.e. pre-programmed) and patient-initiated (i.e. on-demand) real-time assessments, to the participants and in their own environment.

m-RESIST is a system designed to improve illness self-knowledge and facilitate the involvement of caregivers in treatment of individuals with treatment-resistant schizophrenia.

Outcomes

Primary Outcome Measures

Change in Technology Acceptance Model (TAM)

Secondary Outcome Measures

Change in User Experience Questionnaire

Change in EuroQol-5D Health Questionnaire (EQ-5D)

Change in Client Satisfaction Questionnaire (CSQ-8)

Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

Change in Neuropsychological Assessment

Change in Clinical Global Impression-Schizophrenia (CGI-SCH)

Change in Social Functioning Scale (SFS)

Full Information

NCT ID

NCT03064776

First Posted

October 17, 2016

Last Updated

June 25, 2021

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Sheba Medical Center, Semmelweis University, iMinds, AQuAS, Agència de Qualitat i Avaluació Sanitàries

1. Study Identification

Unique Protocol Identification Number

NCT03064776

Brief Title

Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia

Acronym

m-RESIST

Official Title

Pilot Study of m-RESIST, an m-Health Program for Treatment-resistant Schizophrenia: Acceptability, Usability, Satisfaction and Perceived Quality of Life Reported by Patients and Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

July 1, 2017 (Actual)

Study Completion Date

June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Sheba Medical Center, Semmelweis University, iMinds, AQuAS, Agència de Qualitat i Avaluació Sanitàries

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

telemedicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

m-RESIST Patients

Arm Type

Experimental

Arm Description

Arm Title

m-RESIST Caregivers

Arm Type

Experimental

Arm Description

m-RESIST is a system designed to improve illness self-knowledge and facilitate the involvement of caregivers in treatment of individuals with treatment-resistant schizophrenia.

Intervention Type

Device

Intervention Name(s)

m-RESIST Patients

Intervention Description

A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers

Intervention Type

Device

Intervention Name(s)

m-RESIST Caregivers

Intervention Description

A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers

Primary Outcome Measure Information:

Title

Change in Technology Acceptance Model (TAM)

Time Frame