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

Epilepsy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484039
• Other study ID #: IRB201800512
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: December 18, 2022

Study information

• Verified date: June 2022
• Source: University of Florida
• Contact: Ramon Edmundo D Bautista, MD
• Phone: 904-244-9190
• Email: ramon.bautista[@]jax.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 568
• Est. completion date: December 18, 2022
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizure Disorder
• Seizures

Intervention

Behavioral:
• Medication Adherence
Some subjects will be enrolled in a medication adherence course.
• Seizure Documentation
Some subjects will be enrolled in a seizure documentation course.
• Memory Improvement
Some subjects will be enrolled in a memory improvement course.
• Stress Management
Some subjects will be enrolled in a stress management course.

Locations

Country	Name	City	State
United States	UF Health Jacksonville	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Dupont Fund, Jesse Ball, Florida Blue Foundation, Riverside Hospital Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Life in Epilepsy-10 scores	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.	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)