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

NCT03484039 | Completed

• 1 other identifier: IRB201800512
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizure Disorder

Keywords

memory problems; stress; depression; adherence; seizure documentation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Study Arms (1)

Epilepsy Patients

EXPERIMENTAL

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; Behavioral: Seizure Documentation; Behavioral: Memory Improvement; Behavioral: Stress Management

Interventions

Medication Adherence BEHAVIORAL

Some subjects will be enrolled in a medication adherence course.

Epilepsy Patients

Seizure Documentation BEHAVIORAL

Some subjects will be enrolled in a seizure documentation course.

Epilepsy Patients

Memory Improvement BEHAVIORAL

Some subjects will be enrolled in a memory improvement course.

Epilepsy Patients

Stress Management BEHAVIORAL

Some subjects will be enrolled in a stress management course.

Epilepsy Patients

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of non-epileptic seizures
• History of cognitive impairments that prevents them from providing informed consent and completing study assessments

Sponsors & Collaborators

• University of Florida: lead
• Dupont Fund, Jesse Ball: collaborator
• Florida Blue Foundation: collaborator
• Riverside Hospital Foundation: collaborator

Study Sites (1)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Epilepsy; Memory Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Ramon Edmundo D Bautista, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 30, 2018
• Study Start: June 6, 2018
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)