NCT03064776

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2017

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

October 17, 2016

Last Update Submit

June 25, 2021

Conditions

Schizophrenia

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

  • Change in Technology Acceptance Model (TAM)

    Changes from baseline scores at 1-month and 3-months scores

Secondary Outcomes (7)

  • Change in User Experience Questionnaire

    Changes from baseline scores at 1-month and 3-months scores

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

    Changes from baseline scores at 1-month and 3-months scores

  • Change in Client Satisfaction Questionnaire (CSQ-8)

    Changes from baseline scores at 1-month and 3-months scores

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

    Changes from baseline scores at 1-month and 3-months scores

  • Change in Neuropsychological Assessment

    Changes from baseline scores at 1-month and 3-months scores

  • +2 more secondary outcomes

Study Arms (2)

m-RESIST Patients

EXPERIMENTAL

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 behaviour 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 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.

Device: m-RESIST Patients

m-RESIST Caregivers

EXPERIMENTAL

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

Interventions

m-RESIST PatientsDEVICE

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

m-RESIST Patients
m-RESIST CaregiversDEVICE

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

m-RESIST Caregivers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

3Department of Psychiatry and Psychotherapy, Semmelweis University

Budapest, Hungary

Location

The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center

Tel Aviv, Israel

Location

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (2)

  • Grasa E, Seppala J, Alonso-Solis A, Haapea M, Isohanni M, Miettunen J, Caro Mendivelso J, Almazan C, Rubinstein K, Caspi A, Unoka Z, Farkas K, Usall J, Ochoa S, van der Graaf S, Jewell C, Triantafillou A, Stevens M, Reixach E, Berdun J; m-RESIST group; Corripio I. m-RESIST, a Mobile Therapeutic Intervention for Treatment-Resistant Schizophrenia: Feasibility, Acceptability, and Usability Study. JMIR Form Res. 2023 Jun 30;7:e46179. doi: 10.2196/46179.

    PMID: 37389933DERIVED

  • Alonso-Solis A, Rubinstein K, Corripio I, Jaaskelainen E, Seppala A, Vella VA, Caro-Mendivelso J, Caspi A, Isohanni M, Unoka Z, Van der Graff S, Farkas K, Huerta-Ramos E, Marco-Garcia S, Stevens M, Coenen T, Hospedales M, Berdun J; m-Resist group; Grasa EM. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST): a prospective multicentre feasibility study protocol in patients and their caregivers. BMJ Open. 2018 Jul 16;8(7):e021346. doi: 10.1136/bmjopen-2017-021346.

    PMID: 30012788DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Corripio Iluminada, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

February 27, 2017

Study Start

March 1, 2017

Primary Completion

July 1, 2017

Study Completion

June 1, 2019

Last Updated

June 30, 2021

Record last verified: 2019-06

Locations

IL(1)ES(1)HU(1)