NCT04705441Completed
Self-management for People with Epilepsy
Self-management for People with Epilepsy and a History of Negative Health Events (SMART): Targeting Rural and Underserved People with Epilepsy
Source: ClinicalTrials.gov · Last updated 3 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 8 Jan 2021
- Start date
- 19 May 2021
- Primary completion date
- 3 Dec 2024
- Lead sponsor
- Mark A. Granner
- Diseases
- Epilepsy
- NCT number
- NCT04705441
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 19 May 2021 to the primary completion date, 3 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Individuals with a diagnosis of dementia
Other
- Actively suicidal/homicidal
- 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.
- Pregnant women
- Individuals who participated in Phase I of the study
Who the study is looking for
- Have received a previous diagnosis of epilepsy
- Be at least 18 years old
- Have experienced at least 1 NHE in the previous 6 months. NHEs that are obviously not related to having epilepsy, any other health condition, or related to personal activities or behavior (for example, being involved in a bus accident while one is a passenger on the bus) will not be counted as NHEs for this study.
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation or have a legally authorized representative
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.