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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547389
• Other study ID #: nmp/22181
• Status: Completed
• Phase: N/A
• First received: September 2, 2015
• Last updated: September 9, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Community support group

Other:
• Printed material Supported

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NMP Medical Research Institute	Macmillan Research Group UK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with taking prescribed medications	Assessment of compliance with taking medications at regularly scheduled intervals	12 months	No
Secondary	Seizure frequency per month	Assessment of seizure count accuracy by assessing total number of seizures reported per month	change from baseline to 12 months in number of seizures per month assessed by patients diary	No
Secondary	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	change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30	No