Medication Adherence in Individuals With Epilepsy

This study has been completed.
Sponsor:
Collaborators:
Epilepsy Foundation
University of Nebraska
Information provided by (Responsible Party):
Niall Bolger, Columbia University
ClinicalTrials.gov Identifier:
NCT01566500
First received: March 28, 2012
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: April 28, 2015  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Condition: Epilepsy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Study Sample Adults with self-reported epilepsy.

Participant Flow:   Overall Study
    Study Sample  
STARTED     140  
COMPLETED     140  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adults with self-reported epilepsy.

Reporting Groups
  Description
Study Sample Adults with self-reported epilepsy.

Baseline Measures
    Study Sample  
Number of Participants  
[units: participants]
  140  
Age  
[units: years]
Mean (Standard Deviation)
  38.51  (11.72)  
Gender  
[units: participants]
 
Female     87  
Male     53  
Region of Enrollment  
[units: participants]
 
United States     140  



  Outcome Measures

1.  Primary:   Raw Count of Number of Days of Medication Nonadherence   [ Time Frame: Enrollment ]

2.  Secondary:   Score on Barriers to Medication Adherence   [ Time Frame: Enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Score of Psychosocial Predictors of Adherence   [ Time Frame: Enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marie Chesaniuk
Organization: Columbia University
phone: 212-854-0127
e-mail: mc3333@columbia.edu


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Niall Bolger, Columbia University
ClinicalTrials.gov Identifier: NCT01566500     History of Changes
Other Study ID Numbers: AAAI1597
Study First Received: March 28, 2012
Results First Received: April 28, 2015
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board