Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy

NMP Medical Research Institute

Status: Completed

Conditions: Epilepsy

Treatments: Other: Printed material Supported; Behavioral: Community support group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02547389

nmp/22181

Details and patient eligibility

About

Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals.

In order to design an effective intervention on the management of epilepsy, the drug management of epilepsy by community health workers was evaluated.

Enrollment: 144 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
• Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
• Patients must be on at least one anti-epileptic medication.
• Patients must be able to report seizure frequency with either a paper or electronic diary.
• Patients must be able to read and understand either English or Hindi.
• Patients must be able to complete questionnaires and provide informed consent to this study.

Exclusion criteria

• A diagnosis of psychogenic nonepileptic seizures
• Severe depression, anxiety, or psychosis
• Recent problem with substance abuse.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Intervention Group (IG)

Active Comparator group

Description:

IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders).

Treatment:

Behavioral: Community support group

Control Group (CG)

Other group

Description:

Patients in the CG were supplied with only printed epilepsy educational module

Treatment:

Other: Printed material Supported