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

September 9, 2015 updated by: NMP Medical Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group (IG)
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
Other: Control Group (CG)
Patients in the CG were supplied with only printed epilepsy educational module
Other: Printed material Supported

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with taking prescribed medications
Time Frame: 12 months
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
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
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)
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
change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Macmillan Research Group UK

Investigators

  • Principal Investigator: Hitesh K Nayak, NMP Medical Research Institute
  • Study Director: Neha Sharma, PhD, Macmillan Research Group UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nmp/22181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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