Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Policy on Optimal Epilepsy Management (POEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01762215
Recruitment Status : Unknown
Verified January 2013 by Dr. John Hixson, San Francisco Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Collaborators:
San Francisco Veterans Affairs Medical Center
Veterans Administration Epilepsy Centers of Excellence (ECoE)
University of California, San Francisco
PatientsLikeMe
UCB Pharma
Information provided by (Responsible Party):
Dr. John Hixson, San Francisco Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE December 28, 2012
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date January 7, 2013
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Policy on Optimal Epilepsy Management
Official Title  ICMJE Policy on Optimized Epilepsy Management: The Use of an Online Social Media Platform to Collect Patient-Entered Data in the Veteran Population
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Epilepsy
  • Seizure Disorder
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: PatientsLikeMe.com
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01762215
Other Study ID Numbers  ICMJE POEM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. John Hixson, San Francisco Veterans Affairs Medical Center
Study Sponsor  ICMJE Northern California Institute of Research and Education
Collaborators  ICMJE
  • San Francisco Veterans Affairs Medical Center
  • Veterans Administration Epilepsy Centers of Excellence (ECoE)
  • University of California, San Francisco
  • PatientsLikeMe
  • UCB Pharma
Investigators  ICMJE Not Provided
PRS Account Northern California Institute of Research and Education
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP