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

Study Overview
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Brief Summary
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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.

Official Title
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Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Community support group
* Other: Printed material Supported


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group (IG)<br>IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders). | Behavioral: Community support group<br> <br> |
| Other: Control Group (CG)<br>Patients in the CG were supplied with only printed epilepsy educational module | Other: Printed material Supported<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with taking prescribed medications | Assessment of compliance with taking medications at regularly scheduled intervals | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency per month | Assessment of seizure count accuracy by assessing total number of seizures reported per month | change from baseline to 12 months in number of seizures per month assessed by patients diary | 
| Quality of Life (Malay Quality of Life in Epilepsy Inventory-30) | Malay Quality of Life in Epilepsy Inventory-30, to assess for overall change in quality of life measures | change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30 |