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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484039
Enrollment
332
Registered
2018-03-30
Start date
2018-06-06
Completion date
2020-02-18
Last updated
2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Seizure Disorder

Keywords

memory problems, stress, depression, adherence, seizure documentation

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.

Interventions

BEHAVIORALMedication Adherence

Some subjects will be enrolled in a medication adherence course.

BEHAVIORALSeizure Documentation

Some subjects will be enrolled in a seizure documentation course.

BEHAVIORALMemory Improvement

Some subjects will be enrolled in a memory improvement course.

BEHAVIORALStress Management

Some subjects will be enrolled in a stress management course.

Sponsors

Dupont Fund, Jesse Ball
CollaboratorUNKNOWN
Florida Blue Foundation
CollaboratorUNKNOWN
Riverside Hospital Foundation
CollaboratorUNKNOWN
University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Quality of Life in Epilepsy-10 scoresTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026