Policy on Optimal Epilepsy Management (POEM)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study examines the use of an online social media platform (PatientsLikeMe) to assist Veterans with epilepsy. The hypothesis is that the online social media platform, PatientsLikeMe, will improve selected patient-reported outcomes on perceived self-management skills for patients who engage in the website functions.

Condition or disease	Intervention/treatment	Phase
Epilepsy; Seizure Disorder	Behavioral: PatientsLikeMe.com	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Policy on Optimized Epilepsy Management: The Use of an Online Social Media Platform to Collect Patient-Entered Data in the Veteran Population
Study Start Date :	October 2012
Estimated Primary Completion Date :	October 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm

Intervention/treatment

Experimental: PLM; Upon consenting to the study, participants will be asked to register an account on PatientsLikeMe; no personal identifiers will be required. As part of registration patients create a user name and password for the website and share their email with PatientsLikeMe. Participants will be asked to provide a set of demographic variables and to complete a survey assessing elements of self-management, disease knowledge, social support, and quality of life. Paticipants will then use the PatientsLikeMe website for 6 weeks as much as they wish. After 6 weeks the participants are asked to complete a second survey.

Behavioral: PatientsLikeMe.com; PatientsLikeMe (PLM, www.patientslikeme.com) is an established medical social networking website that encourages patients with chronic medical conditions to voluntarily share their story and seek support from a common community. Additionally, PatientsLikeMe is actively exploring opportunities to allow patients to report and track important medical data points with the hope that this will improve their longitudinal care. PatientsLikeMe has developed custom functionality for the epilepsy population including seizure tracking, peer support, and printable doctor visit support sheets.; Other Names: PLM; www.patientslikeme.com

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Epilepsy Self-Management [ Time Frame: 6 weeks ]
   The Epilepsy Self-Management Scale (ESMS) is a 38 item scale that assesses "frequency of use of epilepsy self-management practices." A 5-point Likert scale asks participants to respond from never to always. The scale includes 5 subscales that measure medication management, Information management, Safety management, Seizure management, and Lifestyle Management. Higher scores indicate more frequent use of self-management strategies. The scale and its subscale have been previously validated and used in similar studies.
2. Epilepsy Self-Efficacy [ Time Frame: 6 weeks ]
   The Epilepsy Self-Efficacy Scale is a 33-item scale that measures "aspects of efficacy in the self-management of epilepsy". An 11-point Likert rating scale asks participants to choose from 0, I cannot do at all to 10, sure I can do. The scale contains three dimensions: 1) self-efficacy for medication management, 2) self-efficacy for seizure management and 3) self-efficacy for general management issues. Higher scores correspond to higher levels of self-efficacy. The scale has been validated and used in similar studies of website interventions for epilepsy patients.

Secondary Outcome Measures :

1. Epilepsy Self-Management Information Scale [ Time Frame: 6 weeks ]
   This is a subscale of the Epilepsy Self-Management Scale, which measures the frequency with which patients use strategies to manage information about their epilepsy

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• US Veteran
• Epilepsy (Seizure Disorder)
• >18 years

Exclusion Criteria:

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
San Francisco VA Medical Center	Recruiting
San Francisco, California, United States, 94121
Contact: Stephanie Van Bebber, MSc 415-221-4810 ext 5914 poemstudy@ncire.org
Principal Investigator: John D Hixson, MD

Sponsors and Collaborators

Northern California Institute of Research and Education

San Francisco Veterans Affairs Medical Center

Veterans Administration Epilepsy Centers of Excellence

University of California, San Francisco

PatientsLikeMe

UCB Pharma

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. John Hixson, Assistant Professor of Clinical Neurology, San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier:	NCT01762215 History of Changes
Other Study ID Numbers:	POEM
First Posted:	January 7, 2013
Last Update Posted:	January 7, 2013
Last Verified:	January 2013

Keywords provided by Dr. John Hixson, San Francisco Veterans Administration Medical Center:

Epilepsy; Seizure; Veteran

Additional relevant MeSH terms:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms