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Trial record 20 of 1345 for:    "Seizure Disorder"

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

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ClinicalTrials.gov Identifier: NCT03484039
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
Dupont Fund, Jesse Ball
Florida Blue Foundation
Riverside Hospital Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Seizure Disorder Behavioral: Medication Adherence Behavioral: Seizure Documentation Behavioral: Memory Improvement Behavioral: Stress Management Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 568 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epilepsy Patients
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.
Behavioral: Medication Adherence
Some subjects will be enrolled in a medication adherence course.

Behavioral: Seizure Documentation
Some subjects will be enrolled in a seizure documentation course.

Behavioral: Memory Improvement
Some subjects will be enrolled in a memory improvement course.

Behavioral: Stress Management
Some subjects will be enrolled in a stress management course.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484039


Contacts
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Contact: Ramon Edmundo D Bautista, MD 904-244-9190 ramon.bautista@jax.ufl.edu
Contact: Rebecca Gonzalez, RN 904-244-9970 rebecca.gonzalez@jax.ufl.edu

Locations
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United States, Florida
UF Health Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Ramon E Bautista, MD    904-244-9190    ramon.bautista@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
Dupont Fund, Jesse Ball
Florida Blue Foundation
Riverside Hospital Foundation
Investigators
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Principal Investigator: Ramon Edmundo D Bautista, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03484039     History of Changes
Other Study ID Numbers: IRB201800512
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
memory problems
stress
depression
adherence
seizure documentation

Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms