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Behavioral Intervention

Self-Management Program for Epilepsy (SMART2 Trial)

N/A

Waitlist Available

Led By Martha Sajatovic, MD

Research Sponsored by Gena Ghearing

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years old

Have received a previous diagnosis of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months for the rct sample, with an additional 12 month follow-up extension

Awards & highlights

SMART2 Trial Summary

This trial is a randomized controlled trial with two groups - an intervention group who will receive the SMART program, and a control group who will not. The primary outcome measure is change in seizure frequency from baseline to 3 months.

Who is the study for?

This trial is for adults over 18 with epilepsy who've had at least one seizure not caused by other health issues or behaviors in the past 6 months. It's aimed especially at those in disadvantaged groups, like rural residents or underinsured veterans. People with dementia, current suicidal/homicidal thoughts, pregnant women, and Phase I participants are excluded.Check my eligibility

What is being tested?

The SMART program is being tested to see if it helps people manage their epilepsy better. Participants join group sessions via Zoom for 8 weeks led by a nurse and someone with epilepsy. Afterward, they have monthly phone check-ins for three months to maintain progress.See study design

What are the potential side effects?

Since SMART involves educational and behavioral strategies without medication or medical procedures, there aren't typical side effects as seen with drugs or surgery; however, discussing epilepsy openly may cause emotional discomfort for some.

SMART2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with epilepsy.

SMART2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months for the rct sample, with an additional 12 month follow-up extension

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months for the rct sample, with an additional 12 month follow-up extension

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for the rct sample, with an additional 12 month follow-up extension for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Individual Change in NHEs

Total Reduction in NHEs

Secondary outcome measures

Depressive Symptoms

Epilepsy control

Functional health status

+1 more

Other outcome measures

Confidence in Ability to Manage Epilepsy assessed by ESES

Epilepsy Self-Management Competency

Social Support

+1 more

SMART2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SMART interventionExperimental Treatment1 Intervention

Participants receiving the SMART intervention will participate in 8 group-format 45-60 minute sessions over 10-12 weeks. The intervention sessions are held over Zoom.

Group II: WaitlistActive Control1 Intervention

Individuals randomized to WL will continue in their usual care. After they complete their 13-week and 6-month assessments, they will begin participating in the SMART program.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gena GhearingLead Sponsor

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,243 Total Patients Enrolled

7 Trials studying Epilepsy

768 Patients Enrolled for Epilepsy

Martha Sajatovic, MDPrincipal InvestigatorCase Western Reserve University

20 Previous Clinical Trials

1,406 Total Patients Enrolled

3 Trials studying Epilepsy

289 Patients Enrolled for Epilepsy

Media Library

SMART 2 (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04705441 — N/A

Epilepsy Research Study Groups: SMART intervention, Waitlist

Epilepsy Clinical Trial 2023: SMART 2 Highlights & Side Effects. Trial Name: NCT04705441 — N/A

SMART 2 (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04705441 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol permit individuals aged 20 years or older to participate?

"This clinical trial has a strict eligibility criteria, and only those between 18-90 years old can apply. 103 studies have been conducted for minors while 156 trials are available for patients senior citizens."

Answered by AI

Is there an opportunity for new participants to join this clinical trial currently?

"The research study, initially posted on May 19th 2021 and most recently updated November 2nd 2022, is currently searching for willing participants."

Answered by AI

What is the intended aim of this medical investigation?

"Over a period of 6 months, the primary evaluation outcome will be an individual's change in NHEs. Additionally, Quality of Life Specific to Epilepsy (QOLIE-31), Depressive Symptoms (PHQ-9) and Seizure Control will also be monitored as secondary outcomes; QOLIE ranges from 0 to 100 with higher scores indicating greater wellbeing, PHQ-9 has a range of 0 to 27 where elevated numbers denote increased symptom severity, while seizure control is measured through self-reported frequency data."

Answered by AI

Is my profile compatible with the requirements of this research program?

"This study requires that all individuals who wish to participate must possess aura and be between 18-90 years of age. The total number of subjects for this trial is 160."

Answered by AI

How many participants are contributing to this experiment?

"Indeed, the information posted on clinicaltrials.gov shows that this medical trial is still actively looking to enrol patients. It was first advertised on May 19th 2021 and its details were last updated November 2nd 2022; 160 individuals are required from two distinct health institutions."

Answered by AI

Recent research and studies

TrialsJournal

A Randomized Controlled Trial of Self-management for People with Epilepsy and a History of Negative Health Events (SMART) Targeting Rural and Underserved People with Epilepsy: A Methodologic Report

Ghearing, Gena R., Farren Briggs, Kristin Cassidy, Michael Privitera, Carol Blixen, and Martha Sajatovic. 2021. “A Randomized Controlled Trial of Self-management for People with Epilepsy and a History of Negative Health Events (SMART) Targeting Rural and Underserved People with Epilepsy: A Methodologic Report”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05762-z.

clinicaltrials.govStudy

Self-management for People With Epilepsy

Gena Ghearing 2021. "Self-management for People With Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04705441.

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