Effectiveness of the information technology-aided program of relapse prevention in schizophrenia (ITAREPS): a randomized, controlled, double-blind study.
OBJECTIVE
To evaluate the effectiveness of the Information Technology-Aided Program of Re lapse Prevention in Schizophrenia (ITAREPS).


METHODS
Relapse-prone outpatients with schizophrenia or schizoaffective disorder were randomized to the active (n=75) or control group (n=71). In the active arm, according to the protocol, investigators were prompted to increase the antipsychotic dose upon occurrence of a pharmacological inter vention requiring event (PIRE) detected by ITAREPS.


RESULTS
Intention-to-treat (ITT) analysis found no between-group difference in the hospitalization-free survival rate at 12 months. However, the trial suffered from high non-adherence of investigators in the active group, with no antipsychotic dose increase in 61% of PIREs. Furthermore, Cox regression analysis showed a 11-fold increased risk of hospitalization in the absence of pharmacological intervention following a PIRE (hazard ratio [HR]=10.8; 95% confidence interval [CI] 1.4-80.0; p=0.002). Therefore, a post-hoc as-treated analysis was performed, which demonstrated a nine-fold reduction in the risk of hospitalization in ITAREPS Algorithm-Adherers (IAAs, n=25) compared with the ITAREPS Non-interventional group (INIs, n=70; Kaplan-Meier survival analysis, HR=0.11, 95% CI 0.05-0.28, p=0.009; number needed to treat [NNT]=4, 95% CI 3-10). A significant difference in favor of the IAA group was seen in the number of inpatient days (p<0.05) and costs (p<0.05).


CONCLUSIONS
Future ITAREPS trials should target the underlying mechanisms that cause low investigator adherence to the program.


BACKGROUND
Clinical Trials NCT00712660.
Prague Psychiatric Center, 3rd Faculty of Medicine, Charles University, Center of Neuro psychiatric Studies, Prague, Czech Republic. spaniel@pcp.lf3.cuni.cz
Filip
F
Španiel
Jan
J
Hrdlička
Tomáš
T
Novák
Jiří
J
Kožený
Cyril
C
Höschl
Pavel
P
Mohr
Lucie Bankovská
LB
Motlová
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010359:Patient Readmission / Q000706:statistics & numerical data; D011618:Psychotic Disorders / Q000175:diagnosis / Q000534:rehabilitation*; D012559:Schizophrenia / Q000175:diagnosis / Q000534:rehabilitation*; D055502:Secondary Prevention; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D017216:Telemedicine / Q000379:methods*