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

NCT ID: NCT02547389

Last Updated: 2015-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group (IG)

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

Group Type ACTIVE_COMPARATOR

Community support group

Intervention Type BEHAVIORAL

Control Group (CG)

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

Group Type OTHER

Printed material Supported

Intervention Type OTHER

Interventions

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Community support group

Intervention Type BEHAVIORAL

Printed material Supported

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Macmillan Research Group UK

INDUSTRY

Sponsor Role collaborator

NMP Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hitesh K Nayak

Role: PRINCIPAL_INVESTIGATOR

NMP Medical Research Institute

Neha Sharma, PhD

Role: STUDY_DIRECTOR

Macmillan Research Group UK

Other Identifiers

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nmp/22181

Identifier Type: -

Identifier Source: org_study_id

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