Self-management for People With Epilepsy and a History of Negative Health Events (SMART)

Case Western Reserve University

Status: Completed

Conditions: Epilepsy

Treatments: Behavioral: self-management

Study type: Interventional

Funder types: Other

Identifiers

NCT02970396

12-14-07

Details and patient eligibility

About

This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management.

The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of epilepsy
• Negative health event within the last 6 months
• Able to provide written consent and participate in study procedures

Exclusion criteria

• Immediate risk of self-harm
• Dementia
• Pregnancy
• Unable to read/understand English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

SMART Intervention

Active Comparator group

Description:

Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.

Treatment:

Behavioral: self-management

Wait-list

Active Comparator group

Description:

Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.

Treatment:

Behavioral: self-management