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OpenTrials
Completed

NCT Number: NCT03484039

Incorporating Multidimensional Psychosocial Interventions Improves the Well-being of Individuals With Epilepsy

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.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication Adherence

Behavioral

Some subjects will be enrolled in a medication adherence course.

Seizure Documentation

Behavioral

Some subjects will be enrolled in a seizure documentation course.

Memory Improvement

Behavioral

Some subjects will be enrolled in a memory improvement course.

Stress Management

Behavioral

Some subjects will be enrolled in a stress management course.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Dupont Fund, Jesse Ball
  • Florida Blue Foundation
  • Riverside Hospital Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2018
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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