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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02547389
Enrollment
144
Registered
2015-09-11
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

OTHERPrinted material Supported

Sponsors

Macmillan Research Group UK
CollaboratorINDUSTRY
NMP Medical Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compliance with taking prescribed medications12 monthsAssessment of compliance with taking medications at regularly scheduled intervals

Secondary

MeasureTime frameDescription
Seizure frequency per monthchange from baseline to 12 months in number of seizures per month assessed by patients diaryAssessment of seizure count accuracy by assessing total number of seizures reported per month
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-30Malay Quality of Life in Epilepsy Inventory-30, to assess for overall change in quality of life measures

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026