Effectiveness of the Information Technology-Aided Program of Relapse Prevention in Schizophrenia (ITAREPS): A Randomized, Controlled, Double-Blind Study
Abstrakt
To evaluate the effectiveness of the Information Technology-Aided Program of Re lapse Prevention in Schizophrenia (ITAREPS). 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 intervention 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). Conclusion.
Future ITAREPS trials should target the underlying mechanisms that cause low investigator adherence to the program. Trial registration: Clinical Trials NCT00712660.