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

Not Applicable

Completed

• Conditions: Seizure Disorder; Epilepsy
• Interventions: Behavioral: Medication Adherence; Behavioral: Seizure Documentation; Behavioral: Memory Improvement; Behavioral: Stress Management

• Registration Number: NCT03484039
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2018-06-06
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epilepsy Patients	Memory Improvement	The group will receive the module (a 1-2 hour course on either medication adherence, seizure documentation, memory improvement or stress management) right after a baseline assessment. A post assessment and delayed post assessment will be conducted after the module is administered.
Epilepsy Patients	Medication Adherence	The group will receive the module (a 1-2 hour course on either medication adherence, seizure documentation, memory improvement or stress management) right after a baseline assessment. A post assessment and delayed post assessment will be conducted after the module is administered.
Epilepsy Patients	Seizure Documentation	The group will receive the module (a 1-2 hour course on either medication adherence, seizure documentation, memory improvement or stress management) right after a baseline assessment. A post assessment and delayed post assessment will be conducted after the module is administered.
Epilepsy Patients	Stress Management	The group will receive the module (a 1-2 hour course on either medication adherence, seizure documentation, memory improvement or stress management) right after a baseline assessment. A post assessment and delayed post assessment will be conducted after the module is administered.

Primary Outcome Measures

Name	Time	Method
Changes in Quality of Life in Epilepsy-10 scores	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.

Trial Locations

Locations (1)

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States