Medication Adherence in Individuals With Epilepsy

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01566500
• Collaborator: Epilepsy Foundation (Other), University of Nebraska (Other)
• Enrollment: 140
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 23.4

Study Details

Study Description

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	Intervention/Treatment	Phase
Epilepsy

Study Design

• 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: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Outcome Measures

Primary Outcome Measures

1. Raw Count of Number of Days of Medication Nonadherence [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with Epilepsy

Exclusion Criteria:

• Age (under 18, over 65)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Morningside Campus	New York	New York	United States	10027

Sponsors and Collaborators

• Columbia University
• Epilepsy Foundation
• University of Nebraska

Investigators

• Principal Investigator: Niall Bolger, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Niall Bolger, Professor of Psychology, Columbia University
• ClinicalTrials.gov Identifier: NCT01566500
• Other Study ID Numbers: AAAI1597
• First Posted: Mar 29, 2012
• Last Update Posted: Aug 26, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Niall Bolger, Professor of Psychology, Columbia University: Epilepsy; Medication Adherence
• Additional relevant MeSH terms: Epilepsy

Study Results

Participant Flow

Arm/Group Title	Study Sample
Arm/Group Description	Adults with self-reported epilepsy.
Period Title: Overall Study
STARTED	140
COMPLETED	140
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Study Sample
Arm/Group Description	Adults with self-reported epilepsy.
Overall Participants	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.51 (11.72)
Sex: Female, Male (Count of Participants)
Female	87 62.1%
Male	53 37.9%
Region of Enrollment (participants) [Number]
United States	140 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Adults with self-reported epilepsy.

Arm/Group Title	Study Sample
Arm/Group Description	Adults with self-reported epilepsy.
Measure Participants	140
Number [% of nonadherence days]	28

2. Secondary Outcome

Title	Score on Barriers to Medication Adherence
Description	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.
Time Frame	Enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Score of Psychosocial Predictors of Adherence
Description	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.
Time Frame	Enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	It was an observational study where none of the participants were at risk during the study hence the meaning of "0" Total Number of Participants at Risk.
Arm/Group Title	Study Sample
Arm/Group Description	Adults with self-reported epilepsy.
All Cause Mortality
	Study Sample
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Study Sample
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Study Sample
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

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.