Medication Adherence in Individuals With Epilepsy

NCT01566500 | Completed Results DMC

• 1 other identifier: AAAI1597
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Epilepsy

Keywords

Epilepsy; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Score on Barriers to Medication Adherence

  Enrollment

• Score of Psychosocial Predictors of Adherence

  Enrollment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with Epilepsy

You may not qualify if:

• Age (under 18, over 65)

Sponsors & Collaborators

• Columbia University: lead
• Epilepsy Foundation: collaborator
• University of Nebraska: collaborator

Study Sites (1)

Columbia University Morningside Campus

New York, New York, 10027, United States

Location

Related Publications (1)

• 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.

  PMID: 25461221 DERIVED

MeSH Terms

Conditions

Epilepsy; Medication Adherence

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Marie Chesaniuk
• Organization: Columbia University

mc3333@columbia.edu

212-854-0127

Study Officials

• Niall Bolger, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 29, 2012
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 26, 2015
• Results First Posted: August 26, 2015

Record last verified: 2015-07

Locations

US (1)