Effectiveness of the Information Technology-Aided Program of Relapse Prevention in Schizophrenia (ITAREPS): A Randomized, Controlled, Double-Blind Study

被引:58
|
作者
Spaniel, Filip [1 ]
Hrdlicka, Jan [2 ]
Novak, Tomas [1 ]
Kozeny, Jiri [1 ]
Hoeschl, Cyril [1 ]
Mohr, Pavel [1 ]
Motlova, Lucie Bankovska [1 ]
机构
[1] Charles Univ Prague, Fac Med 3, Prague Psychiat Ctr, Ctr Neuropsychiat Studies, Prague 18103 8, Czech Republic
[2] Czech Tech Univ, Fac Elect Engn, Dept Cybernet, CR-16635 Prague, Czech Republic
关键词
schizophrenia; psychotic disorders; relapse prevention; hospitalizations; antipsychotic medication; information technology; FOLLOW-UP; THERAPY; PREDICTION; SYMPTOMS; EPISODE; COSTS; SIGNS;
D O I
10.1097/01.pra.0000416017.45591.c1
中图分类号
R749 [精神病学];
学科分类号
100205 ;
摘要
Purpose. 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 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 (Journal of Psychiatric Practice 2012; 18: 269-280)
引用
收藏
页码:269 / 280
页数:12
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