Policy on Optimal Epilepsy Management (POEM)

January 4, 2013 updated by: Dr. John Hixson, Northern California Institute of Research and Education

Policy on Optimized Epilepsy Management: The Use of an Online Social Media Platform to Collect Patient-Entered Data in the Veteran Population

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco VA Medical Center
        • Contact:
        • Principal Investigator:
          • John D Hixson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern California Institute of Research and Education

Collaborators

UCB Pharma
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
PatientsLikeMe
Veterans Administration Epilepsy Centers of Excellence (ECoE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POEM (Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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