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Completed

NCT Number: NCT02547389

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community support group

Behavioral

Printed material Supported

Other

Primary outcomes

  1. Compliance with taking prescribed medications

    Time frame: 12 months

    Assessment of compliance with taking medications at regularly scheduled intervals

Secondary outcomes

  1. Seizure frequency per month

    Time frame: 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

  2. Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Collaborators

  • Macmillan Research Group UK

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2015
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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