Singh 2019.
Study name | A home‐based, primary‐care model for epilepsy care in India: basis and design |
Methods | The experimental group will be compared to a routine clinic‐based care group using a cluster‐randomised design in which the unit of analysis is a cluster of 10 people with epilepsy residing in an area cared for by a single accredited government grass‐roots healthcare worker |
Participants | People > 1 year old with active epilepsy were invited to enrol in the trial regardless of prior treatment status. People with febrile seizures, neonatal seizures, single seizures not fulfilling the current operational definition for epilepsy, and acute symptomatic seizures associated with head injury, stroke, and toxic, metabolic, and acute infective conditions were excluded |
Interventions | A home‐based intervention comprises epilepsy medication provision, adherence reinforcement, and epilepsy self‐management and stigma management guidance provided by an auxiliary nurse‐midwife equivalent. |
Outcomes | The primary outcome is treatment adherence as measured by monthly tablet counts supplemented by 2 self‐completed questionnaires. The secondary outcomes include monthly seizure frequency, time to first seizure (in days) after enrolment, proportion of participants experiencing seizure freedom for the duration of the study, and QoL measured by the 'Personal Impact of Epilepsy Scale', all assessed by an independent study nurse. |
Starting date | The screening phase and neurologic evaluations and randomisations have been recently completed and follow‐up is underway. |
Contact information | |
Notes |
AED: antiepileptic drug; MI: motivational interviewing; MMAS: Morisky Medication Adherence Scale; QoL: quality of life