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Seizure Rescue Medication (RM) As Part of a Comprehensive Epilepsy Self-management Package of Care

NCT ID: NCT06346262

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2026-01-01

Brief Summary

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This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.

Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Epilepsy Self Management Epilepsy Seizure Reduction medication Anti-seizure medication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SMART RM

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.

Group Type EXPERIMENTAL

SMART RM

Intervention Type BEHAVIORAL

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).

Valtoco Nasal Product

Intervention Type DRUG

Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Interventions

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SMART RM

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).

Intervention Type BEHAVIORAL

Valtoco Nasal Product

Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have epilepsy
* Have experience with RM
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation


* Provide care support to an individual with epilepsy
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation


* Provide care for individuals with epilepsy - this may include (not limited to) physician, nurse practitioner, physician assistant, nurse, social worker, psychologist
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation


* Have epilepsy
* Have experience with RM
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation


* Have received a previous diagnosis of epilepsy
* Be adults ≥ age 18,
* While on a regimen of anti-epileptic medication, still be experiencing bouts of seizures (e.g. frequent break through or acute repetitive seizures) distinct from their usual seizure pattern , and, in the opinion of the study epilepsy clinician, may need benzodiazepine intervention for seizure control
* Have experienced at least 5 seizures but not more than 100 seizures in the previous 6 months.
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Exclusion Criteria

* Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
* Individuals prescribed opioid medications
* Individuals with acute narrow angle glaucoma
* Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Martha Sajatovic

Physician, UHMG

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

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University Hospitals Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Research Coordinator

Role: CONTACT

Phone: 1-888-819-0004

Email: [email protected]

Facility Contacts

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Study Research Coordinator

Role: primary

Other Identifiers

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STUDY20230921

Identifier Type: -

Identifier Source: org_study_id