Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients

NCT ID: NCT04876820

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-01

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%

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pharmacist-led intervention

Group Type: EXPERIMENTAL

Pharmacist intervention

Intervention Type: OTHER

In the intervention arm, the patient meets with the pharmacist. Pharmaceutical intervention (H1) about anti-epileptic drugs prescribed will be done: information on when to take the medication, what to do if you forget to take it or vomit, and an explanation of adverse events. The aim is to improve medication adherence and patient knowledge. A report will be sent to the community pharmacist.

An assessment of medication adherence to antiepileptic drug by MPR at H1 3 months and 6 months (phone call to community pharmacist) will be done. The health insurance score will also be done.

An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at H1 in pre- post interview -, 3 and 6 months (phone call to patient) will be done.

An assessment of pharmacists' satisfaction about community hospital network by a satisfaction questionnaire will be done.

Standard of care

Group Type: SHAM_COMPARATOR

Standard of care

Intervention Type: OTHER

An assessment of medication adherence to antiepileptic drug by MPR at the inclusion then 3 months and 6 months later will be done by a phone call to the community pharmacist. An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at the inclusion then 3 and 6 months later will be done by a phone call to the patient. The health insurance score will be also done during this call.

Interventions

Pharmacist intervention

In the intervention arm, the patient meets with the pharmacist. Pharmaceutical intervention (H1) about anti-epileptic drugs prescribed will be done: information on when to take the medication, what to do if you forget to take it or vomit, and an explanation of adverse events. The aim is to improve medication adherence and patient knowledge. A report will be sent to the community pharmacist.

An assessment of medication adherence to antiepileptic drug by MPR at H1 3 months and 6 months (phone call to community pharmacist) will be done. The health insurance score will also be done.

An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at H1 in pre- post interview -, 3 and 6 months (phone call to patient) will be done.

An assessment of pharmacists' satisfaction about community hospital network by a satisfaction questionnaire will be done.

Intervention Type: OTHER

Standard of care

An assessment of medication adherence to antiepileptic drug by MPR at the inclusion then 3 months and 6 months later will be done by a phone call to the community pharmacist. An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at the inclusion then 3 and 6 months later will be done by a phone call to the patient. The health insurance score will be also done during this call.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DERAMBURE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hopital Roger Salengro, CHU Lille

Lille, , France

Countries

France

Other Identifiers

2021-A00578-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020_84

Identifier Type: -

Identifier Source: org_study_id