Abstracts

Rationale: Epilepsy is defined by International League Against Epilepsy (ILAE; 1993) as a condition characterized by recurrent (two or more) epileptic seizures, unprovoked by any immediate identified cause. Epilepsy affects over more than 50 million people worldwide and majority of those affected live in low- and middle- income countries (LMICs). Many people with epilepsy in LMICs do not receive appropriate treatment for their condition, leading to large treatment gap.Some of the barriers, like unavailable anti epileptic drugs (AEDs), long distance to health facilities, poverty, cultural beliefs and stigma contribute for the treatment gap. In this study we explored how home-based intervention comprising provision of AEDs , repeated home visits and counseling about self management and stigma abrogation improves treatment adherence to AEDs compared with routine clinic-based care in the community. The secondary aims are to compare the effects of the two care pathways on seizure control and quality of life.  Methods: Using a cluster-randomized trial in which the unit of analysis is a cluster of 10 people with confirmed active epilepsy derived from a screening cluster, residing in an area cared for by a single accredited government grass-roots health care worker we compared the experimental group to a routine clinic-based care group. Subjects in the clinic-based arm (n=20: age range 1-80 years) were asked to attend monthly clinics for review visits and drug dispensing. Those in other arm (n-120; age range 1-67 years) received home based intervention comprising of delivery of AEDs, adherence monitoring, education about epilepsy self management and stigma management guidance provided at a monthly basis by an auxiliary nurse-midwife (ANMs) equivalent. Medications are provided cost free to subjects in both arms. The primary outcome of the trial is treatment adherence evaluated by monthly pill counts and two self-completed questionnaires (SRMS and BMQ score). Secondary outcomes include monthly seizure frequency, time to first seizure (in days) after recruitment to the study, proportion of patients experiencing seizure freedom for the duration of study and quality of life by the 'Personal Impact of Epilepsy Scale' (PIES total score). A structured adverse event inventory is administered once every 6 months.We assessed how frequent home visits where information about the drugs, dosing, frequency, inquiring about side effects, supplying seizure diaries and prescription records could help in improving medication adherence and make home care a feasible option in resource-limited communities .Results will be analyzed using unpaired t test. Effect of covariates including age, gender, duration of epilepsy, socioeconomic status, distance from district hospital , within individual correlation over time will be examined in individual-level, random-effects, logistic-regression models.  Results: After prevalence surveys in India, a prevalence of 10 cases of epilepsy/1000 population was inferred. A decision was made to screen 2000 people in each screening cluster, with 24 clusters in all. Clusters were selected from areas with low sociodemographic indices.  The screening phase, neurological evaluations and randomizations have been recently completed and follow-up is underway. This is an ongoing trial.    Conclusions: Epilepsy care has faced numerous barriers to access of care in LMICs, paucity of trained physicians one of the reasons for poor standards of care. Home based interventions providing proper education, decreasing necessary travel time in elderly and those with physical disability, repeated visits and monitoring can make tremendous change and improve medication adherence and thus quality of life. This would help to maintain a positive lifestyle within their own home and community. It proves to be a feasible option. For providing universal care for epilepsy , allocation of funds, augmenting supply side and dealing with competing private care need to be addressed.  Funding: Supported by an ad hoc grant from Indian Counsel of Medical Research(ICMR).