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Behavioral Intervention

SMART RM for Epilepsy

Phase 4

Recruiting

Led By Martha Sajatovic, MD

Research Sponsored by Martha Sajatovic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

Study Summary

This trial will be done in two phases. In the first phase, the study team will adapt a program called SMART to help people with epilepsy manage their seizures using Rescue Medication. They will also create

Who is the study for?

This trial is for adults with epilepsy who experience repetitive seizures. Participants should be willing to engage in a comprehensive self-management program, which includes education on using rescue medication (RM) effectively. They must commit to attending several virtual meetings and providing feedback.Check my eligibility

What is being tested?

The study tests the SMART RM program, adapted to include rescue medication use for seizure management. Phase 1 involves adapting the program with participant input. In Phase 2, the effectiveness of this tailored SMART-RM will be tested over six months.See study design

What are the potential side effects?

Specific side effects are not detailed here but may relate to Valtoco Nasal Product used as RM; these can include nasal discomfort, an unusual taste in the mouth, or drowsiness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in number of seizures as measured by patient report.

Secondary outcome measures

Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)

Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)

Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SMART RMExperimental Treatment2 Interventions

The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE). The intervention will be remotely delivered in a web-based format using a secure web teleconferencing system (such as Zoom) that will allow us to set up a virtual meeting room. Following the group-session series, participants will have 3 monthly telephone maintenance sessions lasting around 15 minutes. Maintenance session web/telephone calls will be made to study participants by a NE with experience in epilepsy and/or chronic health condition management.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Martha SajatovicLead Sponsor

2 Previous Clinical Trials

66 Total Patients Enrolled

Martha Sajatovic, MDPrincipal InvestigatorUniversity Hospitals

20 Previous Clinical Trials

1,523 Total Patients Enrolled

3 Trials studying Epilepsy

406 Patients Enrolled for Epilepsy

Frequently Asked Questions

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

What is the current number of individuals being included in this clinical trial?

"Indeed, the information on clinicaltrials.gov suggests that this research endeavor is currently open for enrollment. The trial was initially listed on March 5th, 2024, with the latest update posted on April 1st of the same year. In total, 43 eligible individuals are being sought from a single designated site."

Answered by AI

Is this clinical trial currently open for enrollment?

"Indeed, the current information on clinicaltrials.gov affirms that this trial is actively enrolling participants. The study was originally posted on March 5th, 2024 and last revised on April 1st, 2024. Recruitment aims to include 43 candidates from a single site."

Answered by AI

What risks are associated with SMART RM for individuals undergoing treatment?

"Based on our evaluations, the safety rating for SMART RM is graded at 3 by our team due to its Phase 4 status, indicating official approval of this therapeutic approach."

Answered by AI