A randomised trial comparing the clinical and cost effectiveness of usual, facility based care compared to an additional collaborative community care package for people and their families living with ...

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Reference: ISRCTN56877013

A randomised trial comparing the clinical and cost effectiveness of usual, facility based care compared to an additional collaborative community care package for people and their families living with schizophrenia in India

Woman and Man

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Extract

Background and study aims. Community based services for people with schizophrenia are largely lacking in low and middle income country (LAMIC) settings. The lack of accessible care leads to a very large treatment gap and adverse outcomes like continued symptoms, progressive disabilities, high death rates, discrimination and social exclusion. Given the worsening shortage of specialist human resources in these settings, one option of scaling up care is to use lay or non specialist community health workers, working under specialist supervision, deliver additional psychosocial care to a larger number of persons with schizophrenia in the community. Though there is observational evidence in support of community based care from LAMIC, the COPSI trial was designed to compare the clinical- and cost-effectiveness of two service delivery methods for people with moderate to severe schizophrenia across three sites in India. Who can participate? Participants aged between 16-60 years with: ii) a primary ICD 10-DCR diagnosis of schizophrenia (ref); iii) illness duration of at least 12 months of at least moderate severity overall as rated by the Clinical Global Impression- Schizophrenia (CGIS) scale; iv) intention to reside in the study areas for 12 months. What does the study involve? Individuals who had provided informed consent to participate were randomly allocated to receive either i) a collaborative community based care (CCBC) intervention involving lay community health workers delivering an additional (to ongoing clinical care), structured package of psychosocial interventions under the supervision of specialists or ii) a facility-based care (FBC) intervention delivered only by mental health specialists. The hypothesis was that the CCBC intervention would be superior to FBC alone across a range of outcome measures. The primary outcomes of interest were changes in symptoms and disability over 12 months. The secondary outcomes of interest were adherence with prescribed medications, stigma and discrimination experienced by participants and their caregivers, family burden and knowledge and attitudes of caregivers. What are the possible benefits and risks of participating? By participating in the study, you may experience some benefits that may not happen otherwise. Everyone will have the opportunity to talk to a trained researcher. This can be useful in helping you understand your problems better and to discuss these with your treating doctor. If, by chance, you are in the group being visited by the community health worker, you and your family members might see changes in your life after working with him or her. You could find it upsetting to discuss your experiences of having this illness with someone who you do not know well enough. Our research staff will be well trained to recognize and respond to any such issue. If you feel upset about something and do not wish to continue, you can ask for the interview to stop and be rearranged. Where is the study run from? The COPSI study was managed by the Institute of Psychiatry in collaboration with Sangath in Goa, the Schizophrenia Research Foundation in Chennai and Parivartan and Nirmittee at Satara. When is the study starting and how long is it expected to run for? May 2008 to December 2012 Who is funding the study? The Wellcome Trust (UK) Who is the main contact? Professor Graham Thornicroft [email protected]


Inclusion criteria

  • Mental health/schizophrenia

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