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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Behavioral: Community support group; Other: Printed material Supported

• Registration Number: NCT02547389
• Lead Sponsor: NMP Medical Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-09
• Last Update Submitted: 2015-09-09
• Study First Posted: 2015-09-11
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (IG)	Community support group	IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders).
Control Group (CG)	Printed material Supported	Patients in the CG were supplied with only printed epilepsy educational module

Primary Outcome Measures

Name	Time	Method
Compliance with taking prescribed medications	12 months	Assessment of compliance with taking medications at regularly scheduled intervals

Secondary Outcome Measures

Name	Time	Method
Seizure frequency per month	change from baseline to 12 months in number of seizures per month assessed by patients diary	Assessment of seizure count accuracy by assessing total number of seizures reported per month
Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)	change from baseline to 12 months in quality of life assessed by 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