Trial record 32 of 1513 for:    "Epilepsy" OR "pyridoxal 5'-phosphate-dependent epilepsy"

Medication Adherence in Individuals With Epilepsy

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. Identifier: NCT01566500
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : August 26, 2015
Last Update Posted : August 26, 2015
Epilepsy Foundation
University of Nebraska
Information provided by (Responsible Party):
Niall Bolger, Columbia University

Brief Summary:

There is an urgent need to understand the psychological and situational factors that influence medication adherence in individuals with epilepsy. According to the Center for Disease Control (CDC, 2010) about 2.5 million people in the United States have epilepsy and one third of them still have seizures despite receiving treatment. With proper medication, an estimated 60-70% of individuals with new onset epilepsy become, and remain, seizure free (Kwan & Brodie, 2000). Despite the success of medical treatment of epilepsy, many patients do not receive these benefits due to inadequate adherence to medication (Meyer et al., 2010). And, as with other chronic medical conditions, estimates suggest that between 30% and 60% of patients with epilepsy are not adherent with their drug regimens (Green & Simons Morton, 1988; Leppik, 1990; Jones et al., 2006). Poor adherence may be the most important cause of poorly controlled epilepsy (Gomes et al., 1998). Stanaway et al. (1985) found that 31% of seizures were precipitated by nonadherence to medication.

Questions regarding adherence are theoretically informed by Fisher et al. (2006)'s Information Motivation Behavioral Skills (IMB) model. While originally developed to describe, predict, and inform interventions for antiretroviral treatment for human immunodeficiency virus (HIV), this study applies the model to epilepsy for the first time. In addition, this study intends to produce an accurate description of how individuals with epilepsy manage their medication adherence by identifying current self regulation strategies (immediate adherence behaviors, preparatory behaviors, and barrier management strategies) and their situational determinants. Situational determinants can explain some of the fluctuations in medication adherence. Patients who are motivated to take their medications might still show inconsistent medication adherence. For example, patients might miss good opportunities to take their medication or fail to anticipate unexpected barriers such as a spontaneous dinner with friends or a bout of depression. Therefore, the study will take particular care to investigate situational cues such as good opportunities for adherence (e.g., taking medication with regular meals or before brushing teeth) and expected and unexpected barriers. Preparatory behaviors and their cues are also of interest in this study: Some patients use facilitators (such as physical or electronic reminder systems, electronic pill bottles and pill boxes) to ensure adequate medication adherence. Social support can serve a similar function of reminding patients to take their medication. To address these questions, the investigators plan to explore how individual regulation and social support influence medication adherence in patients with epilepsy. The specific aims of the proposed research are:

  1. To test the hypothesis that there will be a main effect of information, motivation and behavioral skills, on adherence behavior, and that a mediation model will show that information and motivation effects are partially mediated through behavioral skills.
  2. To identify self regulation strategies and their situational cues (good opportunities, facilitators, and barriers) for medication adherence among individuals with epilepsy to better describe best practices and challenges.

Condition or disease

Study Type : Observational
Actual Enrollment : 140 participants
Time Perspective: Cross-Sectional
Official Title: Best Practices and Challenges in Medication Adherence for Individuals With Epilepsy
Study Start Date : September 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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

    The primary outcome of this study is medication adherence as measured by self report with a 4 day recall adherence questionnaire (Chesney, Ickovics, Chambers, et al., 2000).

    The total number of Nonadherence days were counted, then divided by the total number of days for all participants.

Secondary Outcome Measures :
  1. Score on Barriers to Medication Adherence [ Time Frame: Enrollment ]
    The Chesney Adherence Questionnaire will be used to measure side effects, drug use and other barriers to medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a four-week recall period.

  2. Score of Psychosocial Predictors of Adherence [ Time Frame: Enrollment ]
    The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a twelve month recall period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 140 participants between 18 and 65 years old will be recruited with the condition that all participants have been diagnosed with epilepsy. The participants will be of diverse ethnic background. It is estimated that the participant population will also include individuals from a disadvantaged socioeconomic and/or educational background.

Inclusion Criteria:

  • Diagnosed with Epilepsy

Exclusion Criteria:

  • Age (under 18, over 65)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566500

United States, New York
Columbia University Morningside Campus
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Epilepsy Foundation
University of Nebraska
Principal Investigator: Niall Bolger, PhD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Niall Bolger, Professor of Psychology, Columbia University Identifier: NCT01566500     History of Changes
Other Study ID Numbers: AAAI1597
First Posted: March 29, 2012    Key Record Dates
Results First Posted: August 26, 2015
Last Update Posted: August 26, 2015
Last Verified: July 2015

Keywords provided by Niall Bolger, Columbia University:
Medication Adherence

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases