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Self-management for People with Epilepsy

NCT04705441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-02-03

No results posted yet for this study

Summary

SMART is a program for adult individuals with sub-optimally controlled epilepsy. It involves educational and behavioral interventions intended to enhance epilepsy self-management.

The group sessions are conducted remotely over the teleconferencing application, Zoom. These sessions are held over an 8 week time period and are co-lead by a trained nurse educator and a trained peer educator. The peer educator is someone with epilepsy and a history of NHEs. Educators use a written curriculum delivered online, and the interactive sessions last 60-90 minutes. Groups are limited to about 6 -12 adult participants.

After the group sessions are done, individuals have 3 telephone maintenance sessions with the nurse educator once a month for the first 3 months after the group sessions end spaced approximately 4 weeks apart.

SMART is intended for adults with epilepsy, especially those who belong to disadvantaged sub groups such as rural populations, veterans with epilepsy and those who are underinsured. People with epilepsy who belong to disadvantaged sub-groups are more likely to have poor outcomes and often end up using expensive crisis-oriented care, and thus potentially might benefit the most from self-management programs if they can be actively engaged.

Conditions

Interventions

BEHAVIORAL

SMART 2

Participants receiving the SMART intervention will participate in 8 group-format 45-60 minute sessions (up to 10 participants per group), which will be collaboratively delivered over Zoom by a Nurse Educator and a Peer Educator with epilepsy. Telephone call-in and supplemental printed materials will be available for those who do not have internet access. The initial group session portion of SMART will be completed over 10-12 weeks. Educational components address the challenges imposed by epilepsy and comorbidity, as well as problem-identification and goal-setting, while Peer Educators and the group format address adherence, social support/social isolation, and self-efficacy. Following group sessions, participants will have 3 brief (no more than 15 minutes) monthly web-based or telephone maintenance sessions conducted by the Nurse Educator. Telephone sessions will address on-going issues of epilepsy self-management, including treatment adherence.

Sponsors & Collaborators

Principal Investigators

  • Martha Sajatovic, MD · Case Western Reserve University

  • Mark Granner, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-12-03
Completion
2024-12-03

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705441 on ClinicalTrials.gov