Self-management for People with Epilepsy

NCT04705441 | Completed

• 1 other identifier: 201910824
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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

Epilepsy

Keywords

Epilepsy; Rural; Self-management

Outcome Measures

Primary Outcomes (2)

• Individual Change in NHEs

  The proportion of individuals with change in their total numbers NHEs in the prior 6 months at baseline compared to week 24 of the trial. NHEs are defined as seizures, emergency department visits, hospitalizations, and self-harm attempts.

  6 months

• Total Reduction in NHEs

  The reduction in NHE counts in the 6 months prior to baseline compared to week 24 of the trial. NHEs are defined as seizures, emergency department visits, hospitalizations, and self-harm attempts.

  6 months

Secondary Outcomes (4)

• Depressive Symptoms

  6 months for the RCT sample, with an additional 12 month follow-up extension

• Functional health status

  6 months for the RCT sample, with an additional 12 month follow-up extension

• Epilepsy control

  6 months for the RCT sample, with an additional 12 month follow-up extension

• Quality of Life Specific to Epilepsy as assessed by QOLIE-31

  6 months for the RCT sample, with an additional 12 month follow-up extension

Other Outcomes (4)

• Confidence in Ability to Manage Epilepsy assessed by ESES

  6 months for the RCT sample, with an additional 12 month follow-up extension

• Social Support

  6 months for the RCT sample, with an additional 12 month follow-up extension

• Stigma for Epilepsy

  6 months for the RCT sample, with an additional 12 month follow-up extension

Study Arms (2)

SMART intervention

EXPERIMENTAL

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.

Behavioral: SMART 2

Waitlist

NO 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.

Interventions

SMART 2 BEHAVIORAL

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.

SMART intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Actively suicidal/homicidal
• Individuals with a diagnosis of dementia
• 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

Sponsors & Collaborators

• Mark A. Granner: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Ghearing GR, Briggs F, Cassidy K, Privitera M, Blixen C, Sajatovic M. 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. 2021 Nov 20;22(1):821. doi: 10.1186/s13063-021-05762-z.

  PMID: 34801061 DERIVED

Related Links

• The Managing Epilepsy Well Network's page for the SMART program

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Mark Granner, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to either the intervention arm or waitlist arm for a period of 6 months. Participants receiving the intervention will participate in 8 web-based group sessions over Zoom led by a Nurse Educator and Peer Educator with epilepsy. The intervention will happen over 10-12 weeks and with virtual follow-up visits in both the intervention and the wait list groups. After month 6 follow-up visits have been completed (the primary study out evaluation), then the waitlist arm will start the SMART intervention and both the original SMART group and original waitlist group will be followed for an additional year.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: May 19, 2021
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: February 3, 2025

Record last verified: 2024-11

Locations

US (2)