Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
1 other identifier
interventional
144
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedSeptember 11, 2015
September 1, 2015
1.2 years
September 2, 2015
September 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Compliance with taking prescribed medications
Assessment of compliance with taking medications at regularly scheduled intervals
12 months
Secondary Outcomes (2)
Seizure frequency 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)
change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30
Study Arms (2)
Intervention Group (IG)
ACTIVE COMPARATORIG additionally received community health programs with health workers(intensive education, consultation services, maintenance of anepilepsy tracking card, and repeated reminders).
Control Group (CG)
OTHERPatients in the CG were supplied with only printed epilepsy educational module
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A diagnosis of psychogenic nonepileptic seizures
- Severe depression, anxiety, or psychosis
- Recent problem with substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NMP Medical Research Institutelead
- Macmillan Research Group UKcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hitesh K Nayak
NMP Medical Research Institute
- STUDY DIRECTOR
Neha Sharma, PhD
Macmillan Research Group UK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 11, 2015
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
September 11, 2015
Record last verified: 2015-09