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
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Seizure Disorder||Behavioral: Medication Adherence Behavioral: Seizure Documentation Behavioral: Memory Improvement Behavioral: Stress Management||Not Applicable|
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.
|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|
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.
- 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.
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
|Contact: Ramon Edmundo D Bautista, MDfirstname.lastname@example.org|
|Contact: Rebecca Gonzalez, RNemail@example.com|
|United States, Florida|
|UF Health Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Ramon E Bautista, MD 904-244-9190 firstname.lastname@example.org|
|Principal Investigator:||Ramon Edmundo D Bautista, MD||University of Florida|