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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

Must not have

Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can provide written consent or have someone who can legally do it for me.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Individual Change in NHEs

Total Reduction in NHEs

Secondary study objectives

Depressive Symptoms

Epilepsy control

Functional health status

+1 more

Other study objectives

Confidence in Ability to Manage Epilepsy assessed by ESES

Epilepsy Self-Management Competency

Social Support

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met