EpilepsyEPIPHARMNCT04876820
Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients
A study testing Pharmacist intervention in people with Epilepsy, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Pharmacist intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge
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
- Being tested
- Pharmacist intervention, Standard of care
- Keywords
- Treatment adherence, epilepsy, hospital pharmacy, clinical pharmacy, pharmacist intervention
- Medical subject headings
- Epilepsy, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist interventionOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-led intervention | Experimental | Not described Receives: Other: Pharmacist intervention |
| Standard of care | Sham comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 3 months after inclusion
Secondary outcomes (7)
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
Measured: at 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
Measured: at 3 months 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.
Measured: at 1 hour, 3 months and 6 months
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
Measured: at 3 months and 6 months
Assessment of health insurance score (Score 0 to 6)
Compare drug adherence via the health insurance score between the 2 arms
Measured: at 3 months and 6 months
Rate of patients with no seizures
Compare the rate of seizure free patients between the two arms
Measured: at 6 months
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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Sponsor's decesion, no inclusion since august 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DERAMBURE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876820
- Sponsor's protocol ID
- 2020_84
- Other IDs
- 2021-A00578-33
- Acronym
- EPIPHARM
- Status last verified
- May 2025
- First submitted
- 30 Apr 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge
- ClinicalTrials.gov ID
- NCT04876820
- Acronym / sponsor ID
- EPIPHARM / 2020_84
- Conditions
- Epilepsy
- Keywords
- Treatment adherence, epilepsy, hospital pharmacy, clinical pharmacy, pharmacist intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decesion, no inclusion since august 2022
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led intervention | Experimental | Other: Pharmacist intervention |
| Standard of care | Sham comparator | Other: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist interventionIn 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. | Other | Pharmacist-led intervention |
| Standard of careAn 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. | Other | Standard of care |
Primary outcome
Medication Possession Ratio (MPR)
Time frame: at 3 months after inclusion
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
7 secondary outcomes
Medication Possession Ratio (MPR)
Time frame: at 6 months after inclusion
Rate of MPR >80 percent
Time frame: at 3 months and 6 months
Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)
Time frame: at 1 hour, 3 months and 6 months
Satisfaction score on a Likert scale (score 1 to 5)
Time frame: at 3 months and 6 months
Assessment of health insurance score (Score 0 to 6)
Time frame: at 3 months and 6 months
Rate of patients with no seizures
Time frame: at 6 months
Rate of patient in whom seizure have decreased by 50 percent
Time frame: at 6 months
Results and safety
The study was stopped early (reason given: Sponsor's decesion, no inclusion since august 2022). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe DERAMBURE, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention in people with Epilepsy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decesion, no inclusion since august 2022). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Possession Ratio (MPR) (time frame: at 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.