Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial

摘要: Summary Background Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised specialists, in low-income and middle-income countries. We did the COmmunity care People Schizophrenia India (COPSI) trial to compare effectiveness of a collaborative intervention standard facility-based care. Methods multicentre, parallel-group, randomised controlled at three sites between Jan 1, 2009 Dec 31, 2010. Patients aged 16–60 years primary diagnosis according tenth edition International Classification Diseases, Diagnostic Criteria Research (ICD-10-DCR) were randomly assigned (2:1), via computer-generated randomisation list block sizes three, six, or nine, receive either plus alone. Randomisation was stratified study site. Outcome assessors masked group allocation. The outcome change symptoms disabilities over 12 months, as measured positive negative syndrome scale (PANSS) Indian disability evaluation assessment (IDEAS). Analysis modified intention treat. This is registered an Standard Randomised Controlled Trial, number ISRCTN 56877013. Findings 187 participants 95 alone group; 253 (90%) completed follow-up month 12. At total PANSS IDEAS scores lower patients than those control (PANSS adjusted mean difference −3·75, 95% CI −7·92 0·42; p=0·08; −0·95, −1·68 −0·23; p=0·01). However, no shown proportion who had reduction more 20% overall 85 [51%] vs 44 p=0·89; 75 [48%] 28 [35%]). noted significant symptom outcomes rural Tamil Nadu site (−9·29, −15·41 −3·17; p=0·003). Two (one each group) died suicide during study, two because complications road traffic accident pre-existing cardiac disease. 18 (73%) (17 admitted hospital course trial, whom seven physical problems, such acute gastritis vomiting, accident, high fever, cardiovascular Interpretation modestly effective care, especially reducing psychosis. Our results show best implemented initial service settings where are scarce, example areas. Funding Wellcome Trust.