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NCT01566500 · ClinicalTrials.gov registry record
Medication Adherence in Individuals With Epilepsy
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 140
- Enrollment target
NCT01566500: Completed study, sponsored by Columbia University.
NCT01566500 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 140 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01566500 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 140 participants
- Enrollment target
Study 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
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-03 |
What the finished NCT01566500 record still lists
NCT01566500 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01566500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01566500 about?
NCT01566500 is a clinical study titled "Medication Adherence in 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 seizu...
What is the current status of trial NCT01566500?
This trial is currently completed. The enrollment target is 140 participants. The study started on 2011-09. Estimated completion is 2012-03.
Who is sponsoring clinical trial NCT01566500?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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