Medication Adherence in Individuals With Epilepsy

Best Practices and Challenges in Medication Adherence for Individuals With Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University Morningside Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Diagnosed with Epilepsy

Exclusion Criteria:

• Age (under 18, over 65)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raw Count of Number of Days of Medication Nonadherence	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.	Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Barriers to Medication Adherence	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.	Enrollment
Score of Psychosocial Predictors of Adherence	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.	Enrollment

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: University of Nebraska; Epilepsy Foundation
• Investigators: Principal Investigator: Niall Bolger, PhD, Columbia University

Publications and helpful links

General Publications

• Chesaniuk M, Choi H, Wicks P, Stadler G. Perceived stigma and adherence in epilepsy: evidence for a link and mediating processes. Epilepsy Behav. 2014 Dec;41:227-31. doi: 10.1016/j.yebeh.2014.10.004. Epub 2014 Nov 1.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Epilepsy; Medication Adherence
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: AAAI1597