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

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ClinicalTrials.gov Identifier: NCT03064776
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
Sheba Medical Center
Semmelweis University
iMinds
AQuAS, Agència de Qualitat i Avaluació Sanitàries
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Device: m-RESIST Patients Device: m-RESIST Caregivers Not Applicable

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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: m-RESIST Patients

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

  1. Continuously capture multidimensional behavior as it occurs in real-time and in real-world environments, using continuous collection and analysis of sensor data.
  2. 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-suport 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.

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

Experimental: m-RESIST Caregivers
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.
Device: m-RESIST Caregivers
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 Measures :
  1. Change in Technology Acceptance Model (TAM) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]

Secondary Outcome Measures :
  1. Change in User Experience Questionnaire [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  2. Change in EuroQol-5D Health Questionnaire (EQ-5D) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  3. Change in Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  4. Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  5. Change in Neuropsychological Assessment [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  6. Change in Clinical Global Impression-Schizophrenia (CGI-SCH) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]
  7. Change in Social Functioning Scale (SFS) [ Time Frame: Changes from baseline scores at 1-month and 3-months scores ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 dopaminergic-receptors RD2 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 (and willingness to participate) of a caregiver or informal carer -family members or significant others- of patients with treatment-resistant schizophrenia.
  • Both patient and caregiver should sign the informed consent before entering the study.

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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064776


Locations
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Hungary
3Department of Psychiatry and Psychotherapy, Semmelweis University
Budapest, Hungary
Israel
The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center
Tel Aviv, Israel
Spain
Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sheba Medical Center
Semmelweis University
iMinds
AQuAS, Agència de Qualitat i Avaluació Sanitàries
Investigators
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Principal Investigator: Corripio Iluminada, MD, PhD Hospital Santa Creu i Sant Pau
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03064776    
Other Study ID Numbers: IIBSP-RES-2016-51
643552 ( Other Grant/Funding Number: EU Horizon2020 research & innovation programme )
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
telemedicine
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders