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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02970396
Other study ID # 12-14-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date December 2018

Study information

Verified date December 2018
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
self-management


Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of negative health events baseline, 6 months
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