EpilepsyPOEMNCT01762215
Policy on Optimal Epilepsy Management
A study testing PatientsLikeMe.com in people with Epilepsy and Seizure Disorder, run by Northern California Institute of Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Seizure Disorder
- What is being tested?
- PatientsLikeMe.com
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US Veteran
- Epilepsy (Seizure Disorder)
- >18 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Stephanie Van Bebber, MSc, 415-221-4810 ext. 5914, poemstudy@ncire.org
John D Hixson, MD
About this study
Official title: 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.
- Conditions
- Epilepsy, Seizure Disorder
- Being tested
- PatientsLikeMe.com
- Keywords
- Epilepsy, Seizure, Veteran
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsLikeMe.comBehavioural
Also called PLM, www.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.
| Study group | Role | What they receive |
|---|---|---|
| PLM | Experimental | 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. Receives: Behavioral: PatientsLikeMe.com |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epilepsy Self-Management
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.
Measured: 6 weeks
Epilepsy Self-Efficacy
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.
Measured: 6 weeks
Secondary outcomes (1)
Epilepsy Self-Management Information Scale
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, Veterans Administration Epilepsy Centers of Excellence (ECoE), University of California, San Francisco, PatientsLikeMe, UCB Pharma
- Responsible party
- Principal investigator, Dr. John Hixson, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762215
- Sponsor's protocol ID
- POEM
- Acronym
- POEM
- Status last verified
- Jan 2013
- First submitted
- 28 Dec 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policy on Optimized Epilepsy Management: The Use of an Online Social Media Platform to Collect Patient-Entered Data in the Veteran Population
- ClinicalTrials.gov ID
- NCT01762215
- Acronym / sponsor ID
- POEM / POEM
- Conditions
- Epilepsy, Seizure Disorder
- Keywords
- Epilepsy, Seizure, Veteran
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, Veterans Administration Epilepsy Centers of Excellence (ECoE), University of California, San Francisco, PatientsLikeMe, UCB Pharma
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLM | Experimental | Behavioral: PatientsLikeMe.comUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- US Veteran
- Epilepsy (Seizure Disorder)
- >18 years
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsLikeMe.comAlso: PLM, www.patientslikeme.comPatientsLikeMe (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. | Behavioural | PLM |
Primary outcome
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.
1 secondary outcome
Epilepsy Self-Management Information Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
San Francisco VA Medical Center
San Francisco, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PatientsLikeMe.com in people with Epilepsy and Seizure Disorder, run by Northern California Institute of Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epilepsy Self-Management (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.