Trial Outcomes & Findings for Medication Adherence in Individuals With Epilepsy (NCT NCT01566500)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

140 participants

Primary outcome timeframe

Enrollment

Results posted on

2015-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Study Sample Adults with self-reported epilepsy.
Overall Study STARTED	140
Overall Study COMPLETED	140
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medication Adherence in Individuals With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Sample n=140 Participants Adults with self-reported epilepsy.
Age, Continuous	38.51 years STANDARD_DEVIATION 11.72 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment United States	140 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment

Population: Adults with self-reported epilepsy.

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.

Outcome measures

Outcome measures
Measure	Study Sample n=140 Participants Adults with self-reported epilepsy.
Raw Count of Number of Days of Medication Nonadherence	28 % of nonadherence days

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Study Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie Chesaniuk

Columbia University

Phone: 212-854-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place