Medication Adherence in Individuals With Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Columbia University.
Recruitment status was  Recruiting
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: NA
Last verified: March 2012
History: No changes posted
  Purpose

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
Epilepsy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Best Practices and Challenges in Medication Adherence for Individuals With Epilepsy

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Raw count of number of days of medication adherence [ Time Frame: Four days prior to enrollment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Score on Barriers to Medication Adherence [ Time Frame: Four weeks prior to enrollment ] [ Designated as safety issue: No ]
    The Chesney Adherence Questionnaire will be used to measure side effects, dug use and other barriers to medication adherence

  • Score of psychosocial predictors of Adherence [ Time Frame: Twelve months prior to enrollment ] [ Designated as safety issue: No ]
    The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence


Estimated Enrollment: 130
Study Start Date: September 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 130 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.

Criteria

Inclusion Criteria:

  • Diagnosed with Epilepsy

Exclusion Criteria:

  • Age (under 18, over 65)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566500

Locations
United States, New York
Columbia University Morningside Campus Recruiting
New York, New York, United States, 10027
Contact: Marie Chesaniuk, M.A.    516-650-6638    mc3333@columbia.edu   
Sub-Investigator: Gertraud Stadler, PhD         
Sponsors and Collaborators
Columbia University
Epilepsy Foundation
University of Nebraska
Investigators
Principal Investigator: Niall Bolger, PhD Columbia University
  More Information

No publications provided

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

Keywords provided by Columbia University:
Epilepsy
Medication Adherence

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

ClinicalTrials.gov processed this record on September 30, 2014