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临床试验/NCT04876820
NCT04876820终止不适用

Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
51
试验地点
2
主要终点
Medication Possession Ratio (MPR)

研究概览

简要总结

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%

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Inpatients
  • Patient under curatorship, guardianship and/or institutionalized
  • 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

结局指标

主要结局

Medication Possession Ratio (MPR)

时间窗: 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

次要结局

  • Rate of MPR >80 percent(at 3 months and 6 months)
  • Assessment of health insurance score (Score 0 to 6)(at 3 months and 6 months)
  • Medication Possession Ratio (MPR)(at 6 months after inclusion)
  • Rate of patient in whom seizure have decreased by 50 percent(at 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)
  • Rate of patients with no seizures(at 6 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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