Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients

NCT04876820 | Terminated

• 2 other identifiers: 2020_842021-A00578-33
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Treatment adherence; epilepsy; hospital pharmacy; clinical pharmacy; pharmacist intervention

Outcome Measures

Primary Outcomes (1)

• Medication Possession Ratio (MPR)

  Compare adherence to antiepileptic drugs between patients who received pharmacist led intervention and those who did not by Medication Possession Ratio (MPR) 3 months after inclusion

  at 3 months after inclusion

Secondary Outcomes (7)

• Medication Possession Ratio (MPR)

  at 6 months after inclusion

• Rate of MPR >80 percent

  at 3 months and 6 months

• Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)

  at 1 hour, 3 months and 6 months

• Satisfaction score on a Likert scale (score 1 to 5)

  at 3 months and 6 months

• Assessment of health insurance score (Score 0 to 6)

  at 3 months and 6 months

Study Arms (2)

Pharmacist-led intervention

EXPERIMENTAL

Other: Pharmacist intervention

Standard of care

SHAM COMPARATOR

Other: Standard of care

Interventions

Pharmacist intervention 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.

Pharmacist-led intervention

Standard of care 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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Epilepsy; Treatment Adherence and Compliance

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Philippe DERAMBURE, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 7, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

FR (1)