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Self-management for People With Epilepsy (SMART2)

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ClinicalTrials.gov Identifier: NCT04705441
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : July 12, 2021
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Gena Ghearing, University of Iowa

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 initial group session is in-person where individuals receive curriculum materials and learn to utilize the Web format (such as Adobe Connect or ZOOM) and a teleconferencing service needed to access the remainder of the group sessions. 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 8 telephone maintenance sessions with the nurse educator and the peer educator spaced approximately 2 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.


Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: SMART 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-management for People With Epilepsy and a History of Negative Health Events (SMART): Targeting Rural and Underserved People With Epilepsy
Actual Study Start Date : May 19, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: SMART 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.
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.

No Intervention: Waitlist
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.



Primary Outcome Measures :
  1. Individual Change in NHEs [ Time Frame: 6 months ]
    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.

  2. Total Reduction in NHEs [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Patient Health Questionnaire-9 (PHQ-9) is a widely used and validated self-rated depression scale. The possible score range is 0-27. Higher scores mean more severe depressive symptom severity.

  2. Functional health status [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Short Form-36 (SF-36) -- a multipurpose, short-form health survey that yields two psychometrically-based components: a physical component summary (PCS) and mental component summary (MCS).The possible score range is 0 to 100. The lower the score, the better the outcome.

  3. Epilepsy control [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Epilepsy control will be assessed via self-reported seizure frequency.

  4. Quality of Life Specific to Epilepsy as assessed by QOLIE-31 [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Quality of life will be assessed with the Quality of life in epilepsy (QOLIE-31) self-administered questionnaire which comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The possible score range is from 0 to 100. A higher score indicates a better quality of life, therefore a better outcome.


Other Outcome Measures:
  1. Confidence in Ability to Manage Epilepsy assessed by ESES [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    The Epilepsy Self-Efficacy Scale (ESES) 2000 version will be used to assess confidence in a participant's ability to manage epilepsy. The possible score range is 0 to 330. Higher scores mean a better outcome.

  2. Social Support [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item scale that measures an individual's perception of social support provided by family and friends, as well as satisfaction with that support. The possible score range is from 12 to 84. Higher scores indicate higher perceived levels of social support.

  3. Stigma for Epilepsy [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Stigma for Epilepsy will be measured using the 24-item Stigma Scale of Epilepsy (SSE), The SSE is a validated, versatile and sensitive instrument which has been used mainly in resource poor settings to study stigma in epilepsy. The possible score range is 0 to 100. Higher scores mean a higher perception of stigma with epilepsy.

  4. Epilepsy Self-Management Competency [ Time Frame: 6 months for the RCT sample, with an additional 12 month follow-up extension ]
    Epilepsy self-management competency will be measured with the Epilepsy Self-Management Scale (ESMS), a 38 item scale that assesses frequency of use of epilepsy self-management practices. The possible score range is 38-190. Higher scores indicate more frequent use of self-management strategies, meaning a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705441


Contacts
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Contact: Gena Ghearing, MD 3194803024 gena-ghearing@uiowa.edu
Contact: Martha Sajatovic, MD 2168442808 martha.sajatovic@uhhospitals.org

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Gena Ghearing, MD    319-480-3024    gena-ghearing@uiowa.edu   
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Martha Sajatovic, MD    216-844-2808    martha.sajatovic@uhhospitals.org   
Sponsors and Collaborators
Gena Ghearing
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
Principal Investigator: Gena Ghearing, MD University of Iowa
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gena Ghearing, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT04705441    
Other Study ID Numbers: 201910824
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gena Ghearing, University of Iowa:
Epilepsy
Rural
Self-management
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases