Schizophrenia Clinical Trial
— m-RESISTOfficial 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
Verified date | June 2019 |
Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | June 1, 2019 |
Est. primary completion date | July 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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.- |
Country | Name | City | State |
---|---|---|---|
Hungary | 3Department of Psychiatry and Psychotherapy, Semmelweis University | Budapest | |
Israel | The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center | Tel Aviv | |
Spain | Department of Psychiatry. Hospital Santa Creu i Sant Pau | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | AQuAS, Agència de Qualitat i Avaluació Sanitàries, iMinds, Semmelweis University, Sheba Medical Center |
Hungary, Israel, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Technology Acceptance Model (TAM) | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in User Experience Questionnaire | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in EuroQol-5D Health Questionnaire (EQ-5D) | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in Client Satisfaction Questionnaire (CSQ-8) | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in Neuropsychological Assessment | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in Clinical Global Impression-Schizophrenia (CGI-SCH) | Changes from baseline scores at 1-month and 3-months scores | ||
Secondary | Change in Social Functioning Scale (SFS) | Changes from baseline scores at 1-month and 3-months scores |
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