Clinical trial NCT01885923: A RCT Study in Schizophrenia Relapse Prevention
Official title: Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relapse Schizophrenia
Keywords: schizophrenia; relapse prevention; information technology
Lead sponsor: Prague Psychiatric Center
Sponsor class: OTHER_GOV
First posted: 2013-06-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.

Detailed description: The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.

Eligibility criteria: Inclusion Criteria:

For entry into the study, the following criteria MUST be met:

* Men and women, ages 18 to 60 years, inclusive.
* A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
* Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
* Severity (CGI-S) ≤ 3 at study Visit 1.
* All patients must be on stable doses of antipsychotic medication during the study entry.

Exclusion Criteria:

* Organic mental disorder,
* mental disorder due to psychoactive substance use or mental retardation.
* Participation in another relapse prevention program.
* Hayward compliance rating scale score \< 2 at Visit 1.

Primary outcomes:
measure: Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group.
timeFrame: 18 months
Secondary outcomes:
measure: Number of psychiatric hospitalization days
timeFrame: 18months
measure: Direct impatient costs
timeFrame: 18months
measure: Direct cost of outpatient antipsychotic medication
timeFrame: 18months
measure: Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups
timeFrame: 18months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Prague Psychiatric Center
Study officials:
affiliation: Prague Psychiatric Center
name: Filip Spaniel, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Spaniel F, Novak T, Bankovska Motlova L, Capkova J, Slovakova A, Trancik P, Matejka M, Hoschl C. Psychiatrist's adherence: a new factor in relapse prevention of schizophrenia. A randomized controlled study on relapse control through telemedicine system. J Psychiatr Ment Health Nurs. 2015 Dec;22(10):811-20. doi: 10.1111/jpm.12251. Epub 2015 Jul 14.