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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547389
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Collaborator:
Macmillan Research Group UK
Information provided by (Responsible Party):
NMP Medical Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Community support group Other: Printed material Supported Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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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
Control Group (CG)
Patients in the CG were supplied with only printed epilepsy educational module
 Other: Printed material Supported


Outcome Measures
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Primary Outcome Measures :
  1. Compliance with taking prescribed medications [ Time Frame: 12 months ]
    Assessment of compliance with taking medications at regularly scheduled intervals


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547389


Sponsors and Collaborators
NMP Medical Research Institute
Macmillan Research Group UK
Investigators
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Principal Investigator: Hitesh K Nayak NMP Medical Research Institute
Study Director: Neha Sharma, PhD Macmillan Research Group UK
More Information
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Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT02547389    
Other Study ID Numbers: nmp/22181
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases