Clinical trial NCT04876820: Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients
Official title: Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Keywords: Treatment adherence
epilepsy
hospital pharmacy
clinical pharmacy
pharmacist intervention
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Many studies have reported a disparity in medication adherence among epileptic patients. In this population, Medication Possession Ratio (MPR) is an index of medication adherence. MPR is defined as the ratio of the number of days of treatment delivered to the number of days in the period of interest.

No-adherents patients are defined by a MPR of less than 80% , in whom an increase in seizures and the rate of hospitalization can be observed. A pharmacist-led intervention and medication information to epileptic patients could improve patient medication adherence to antiepileptic drugs, and possibly decrease the frequency of seizures, hospitalizations and the health costs generated by these hospitalizations. This intervention could also improve patient knowledge about their medications.

The aim of this study is to evaluate the effectiveness of a pharmacist-led intervention on medication adherence of epileptic patients with the MPR. Secondary objectives include the comparison of medication adherence with health insurance score, the evaluation of patients knowledges about their medications, community pharmacists' satisfaction about community hospital network, the comparison of the seizure free patient rate and the comparison of the rate of patient in whom seizure have decreased by 50%


Eligibility criteria: Inclusion Criteria:

* Epileptic patients seeing a neurologist in the neurophysiology clinic with a regular follow-up by the Lille University Hospital reference center
* Adult over 18 years old
* Living at home
* Socially insured patient
* In the case of cognitive problems, the presence of a reliable caregiver managing the medications

Exclusion Criteria:

* Inpatients
* Patient under curatorship, guardianship and/or institutionalized
* Dementia
* Patient who has participated in a therapeutic education program (TEP) about his epilepsy within the previous two years
* Administrative reasons: impossibility to receive informed information, impossibility to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form.
* Switching to home care by a registered nurse for treatment management

Primary outcomes:
measure: Medication Possession Ratio (MPR)
timeFrame: at 3 months after inclusion
Secondary outcomes:
measure: Medication Possession Ratio (MPR)
timeFrame: at 6 months after inclusion
measure: Rate of MPR >80 percent
timeFrame: at 3 months and 6 months
measure: Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)
timeFrame: at 1 hour, 3 months and 6 months
measure: Satisfaction score on a Likert scale (score 1 to 5)
timeFrame: at 3 months and 6 months
measure: Assessment of health insurance score (Score 0 to 6)
timeFrame: at 3 months and 6 months
measure: Rate of patients with no seizures
timeFrame: at 6 months
measure: Rate of patient in whom seizure have decreased by 50 percent
timeFrame: at 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe DERAMBURE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: