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EpilepsyNCT01566500

Medication Adherence in Individuals With Epilepsy

An observational study of Epilepsy, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epilepsy
How many people
140 participants
Where
1 siteUnited States
Study dates
Sep 2011to Mar 2012
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Diagnosed with Epilepsy

Who cannot join

  • Age (under 18, over 65)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University Morningside Campus

    New York, New York, 10027

Other trials in United States

About this study

Official title: 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.
Conditions
Epilepsy
Keywords
Epilepsy, Medication Adherence
Medical subject headings
Epilepsy, Medication Adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Enrollment

Secondary outcomes (2)
  1. 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.

    Measured: Enrollment

  2. 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.

    Measured: Enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01566500
Sponsor's protocol ID
AAAI1597
Status last verified
Jul 2015
First submitted
28 Mar 2012
Last updated
26 Aug 2015
Data monitoring committee
Yes

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.

    PubMed 25461221

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Raw Count of Number of Days of Medication Nonadherence (time frame: Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01566500, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.

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