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Clinical Trials/NCT03484039
NCT03484039
Completed
Not Applicable

The Epilepsy Wellness Center: Incorporating Multidimensional Self-management Psychosocial Interventions in Epilepsy Care Improves the Well-being of Individuals With Epilepsy: a Feasibility and Proof-of-concept Study

University of Florida1 site in 1 country332 target enrollmentJune 6, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University of Florida
Enrollment
332
Locations
1
Primary Endpoint
Changes in Quality of Life in Epilepsy-10 scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to incorporate multidimensional self-management programs into the routine care of epilepsy patients. Consenting patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression.

Detailed Description

Though tremendous advances have been made in the diagnosis and treatment of individuals with epilepsy, much remains to be done when it comes to improving their psychosocial well-being. Many individuals with epilepsy have difficulty adhering to treatment, documenting their seizure types, coping with memory difficulties, dealing with stress, and suffer from depression. These factors limit the quality of life of epilepsy patients and prevent them from realizing their full potential. Patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression. Patient assessments will be conducted before and after intervention to gauge the efficacy of the programs. The specific aims of this study are to assess the feasibility and patient acceptability of incorporating multidimensional self-management and psychosocial interventions into routine epileptic care, as well as, determine whether these incorporations improve self-management, quality-of-life, and other measures of well-being.

Registry
clinicaltrials.gov
Start Date
June 6, 2018
End Date
February 18, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of epilepsy using established criteria
  • Patient self-identified as own primary caregiver
  • English fluency
  • Ability to provide informed consent
  • Ability to complete the study assessments

Exclusion Criteria

  • History of non-epileptic seizures
  • History of cognitive impairments that prevents them from providing informed consent and completing study assessments

Outcomes

Primary Outcomes

Changes in Quality of Life in Epilepsy-10 scores

Time Frame: To be administered at baseline (upon subject screening), pre-intervention (with 2 weeks prior to intervention), post-intervention (between 6 weeks to 3 months post-intervention), and delayed post-intervention (within 4&1/2 to 6 months post-intervention)

This is a well-validated measure of quality of life for epilepsy patients. The unit of measure is a composite score ranging from 0-100 with higher scores indicating better quality of life.

Study Sites (1)

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