Incorporating Multidimensional Psychosocial Interventions Improves the Well-being of Individuals With Epilepsy
Primary Purpose
Epilepsy, Seizure Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Adherence
Seizure Documentation
Memory Improvement
Stress Management
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring memory problems, stress, depression, adherence, seizure documentation
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
Sites / Locations
- UF Health JacksonvilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epilepsy Patients
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03484039
First Posted
March 14, 2018
Last Updated
June 28, 2022
Sponsor
University of Florida
Collaborators
Dupont Fund, Jesse Ball, Florida Blue Foundation, Riverside Hospital Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03484039
Brief Title
Incorporating Multidimensional Psychosocial Interventions Improves the Well-being of Individuals With Epilepsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
December 18, 2022 (Anticipated)
Study Completion Date
December 18, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Dupont Fund, Jesse Ball, Florida Blue Foundation, Riverside Hospital Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizure Disorder
Keywords
memory problems, stress, depression, adherence, seizure documentation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will be enrolled in one module of own choice. Except for Module 3 Submodule 2, every module will consist of a particular intervention, as well as, its accompanying set of assessments.
Masking
None (Open Label)
Allocation
N/A
Enrollment
568 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epilepsy Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Adherence
Intervention Description
Some subjects will be enrolled in a medication adherence course.
Intervention Type
Behavioral
Intervention Name(s)
Seizure Documentation
Intervention Description
Some subjects will be enrolled in a seizure documentation course.
Intervention Type
Behavioral
Intervention Name(s)
Memory Improvement
Intervention Description
Some subjects will be enrolled in a memory improvement course.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management
Intervention Description
Some subjects will be enrolled in a stress management course.
Primary Outcome Measure Information:
Title
Changes in Quality of Life in Epilepsy-10 scores
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Edmundo D Bautista, MD
Phone
904-244-9190
Email
ramon.bautista@jax.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Edmundo D Bautista, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon E Bautista, MD
Phone
904-244-9190
Email
ramon.bautista@jax.ufl.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Incorporating Multidimensional Psychosocial Interventions Improves the Well-being of Individuals With Epilepsy
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