Back to resultsEnhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community support group
Printed material Supported
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention Group (IG)
Control Group (CG)
Arm Description
IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders).
Patients in the CG were supplied with only printed epilepsy educational module
Outcomes
Primary Outcome Measures
Compliance with taking prescribed medications
Assessment of compliance with taking medications at regularly scheduled intervals
Secondary Outcome Measures
Seizure frequency per month
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)
Malay Quality of Life in Epilepsy Inventory-30, to assess for overall change in quality of life measures
Full Information
NCT ID
NCT02547389
First Posted
September 2, 2015
Last Updated
September 9, 2015
Sponsor
NMP Medical Research Institute
Collaborators
Macmillan Research Group UK
1. Study Identification
Unique Protocol Identification Number
NCT02547389
Brief Title
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
Official Title
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Macmillan Research Group UK
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (IG)
Arm Type
Active Comparator
Arm Description
IG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders).
Arm Title
Control Group (CG)
Arm Type
Other
Arm Description
Patients in the CG were supplied with only printed epilepsy educational module
Intervention Type
Behavioral
Intervention Name(s)
Community support group
Intervention Type
Other
Intervention Name(s)
Printed material Supported
Primary Outcome Measure Information:
Title
Compliance with taking prescribed medications
Description
Assessment of compliance with taking medications at regularly scheduled intervals
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Seizure frequency per month
Description
Assessment of seizure count accuracy by assessing total number of seizures reported per month
Time Frame
change from baseline to 12 months in number of seizures per month assessed by patients diary
Title
Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)
Description
Malay Quality of Life in Epilepsy Inventory-30, to assess for overall change in quality of life measures
Time Frame
change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitesh K Nayak
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Macmillan Research Group UK
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
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