Clinical trial NCT03484039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizure Disorder
Keywords: memory problems
stress
depression
adherence
seizure documentation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Dupont Fund, Jesse Ball
name: Florida Blue Foundation
name: Riverside Hospital Foundation
First posted: 2018-03-30
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in Quality of Life in Epilepsy-10 scores
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Ramon Edmundo D Bautista, MD
role: PRINCIPAL_INVESTIGATOR
References: