Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients (EPIPHARM)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacist intervention
Standard of care
Sponsored by
About this trial
This is an interventional other trial for Epilepsy focused on measuring Treatment adherence, epilepsy, hospital pharmacy, clinical pharmacy, pharmacist intervention
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
Sites / Locations
- Hopital Roger Salengro, CHU LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Pharmacist-led intervention
Standard of care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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) 6 months after inclusion
Rate of MPR >80 percent
Compare the rate of adherent patients rate (MPR > 80 percent) between the two arms at 3 and 6 months
Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)
Evaluate the development (before vs after led pharmacist intervention) and maintenance of patient knowledge of patients received pharmacist intervention and compare them to the patient knowledge who received conventional management.
Satisfaction score on a Likert scale (score 1 to 5)
Evaluate the satisfaction of community pharmacist about community hospital network by a satisfaction questionnaire in the intervention group
Assessment of health insurance score (Score 0 to 6)
Compare drug adherence via the health insurance score between the 2 arms
Rate of patients with no seizures
Compare the rate of seizure free patients between the two arms
Rate of patient in whom seizure have decreased by 50 percent
Compare the rate of patient in whom seizure have decreased by 50 percent between the two arms
Full Information
NCT ID
NCT04876820
First Posted
April 30, 2021
Last Updated
November 8, 2022
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT04876820
Brief Title
Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients
Acronym
EPIPHARM
Official Title
Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Treatment adherence, epilepsy, hospital pharmacy, clinical pharmacy, pharmacist intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist-led intervention
Arm Type
Experimental
Arm Title
Standard of care
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Pharmacist intervention
Intervention Description
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
Intervention Name(s)
Standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Possession Ratio (MPR)
Description
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
Time Frame
at 3 months after inclusion
Secondary Outcome Measure Information:
Title
Medication Possession Ratio (MPR)
Description
Compare adherence to antiepileptic drugs between patients who received pharmacist led intervention and those who did not by Medication Possession Ratio (MPR) 6 months after inclusion
Time Frame
at 6 months after inclusion
Title
Rate of MPR >80 percent
Description
Compare the rate of adherent patients rate (MPR > 80 percent) between the two arms at 3 and 6 months
Time Frame
at 3 months and 6 months
Title
Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)
Description
Evaluate the development (before vs after led pharmacist intervention) and maintenance of patient knowledge of patients received pharmacist intervention and compare them to the patient knowledge who received conventional management.
Time Frame
at 1 hour, 3 months and 6 months
Title
Satisfaction score on a Likert scale (score 1 to 5)
Description
Evaluate the satisfaction of community pharmacist about community hospital network by a satisfaction questionnaire in the intervention group
Time Frame
at 3 months and 6 months
Title
Assessment of health insurance score (Score 0 to 6)
Description
Compare drug adherence via the health insurance score between the 2 arms
Time Frame
at 3 months and 6 months
Title
Rate of patients with no seizures
Description
Compare the rate of seizure free patients between the two arms
Time Frame
at 6 months
Title
Rate of patient in whom seizure have decreased by 50 percent
Description
Compare the rate of patient in whom seizure have decreased by 50 percent between the two arms
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe DERAMBURE, MD,PhD
Phone
0320445962
Ext
+33
Email
philippe.derambure@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny MOREAU, PhD
Phone
0320445962
Ext
+33
Email
fanny.moreau@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DERAMBURE, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Roger Salengro, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
Learn more about this trial
Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients
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