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临床试验/NCT05830981
NCT05830981已完成不适用

Valproic Acid Use Evaluation in Patients With Neurological Disorders: a Retrospective and Prospective Analysis

Damanhour University0 个研究点目标入组 600 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
主要终点
Medication errors (Number)

研究概览

简要总结

Sodium valproate is a well-known anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of mood stabilizers. Aim of the present study is to assess sodium valproate usage among patients with neurological disorders.

Prescriptions of 600 patients from out-patient pharmacy of neurology department at Mansoura university teaching hospital were analyzed in a retrospective prospective observational study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

详细描述

This quasi-experimental pretest-posttest design study was conducted at the outpatient's pharmacy of Neurology department at tertiary care hospital. After identifying problems with use and completing a follow-up, 3 months of educational intervention (Lectures) among professionals was given. As this study is observational informed consent from all subjects was waived. The subjects were enrolled on the basis of inclusion and exclusion criteria. Patients receiving at least 7 days of Valproic acid, between 10-70 years old, both sexes, were included in the study figure 1. 600 Prescriptions were reviewed between January of 2015 to December of 2017 for patients who were suffering from any psychotic illness and were on psychiatric medications. Then pharmacist educational intervention started and followed up for three months then prescriptions re-evaluted.

Inclusion/ exclusion criteria: The study population was limited to those who were continuously eligible for the outpatient pharmacy refilling thier medications during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period. A designed and structured form was used to collect the required information. Data then collected on Microsoft Excel sheet, which included patients' initial therapeutic indications, concomitant use of oral medications, significant adverse drug effects and any drug -drug interaction.

研究设计

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

入排标准

年龄范围
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The study population was limited to those who prescribed with valproate and were continuously eligible for the outpatient during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period.

排除标准

  • •Patients who not use valproate.

研究组 & 干预措施

Phase 1

No Intervention

n=600

Phase 2

Active Comparator

n=504

干预措施: Educational intervention (Other)

结局指标

主要结局

Medication errors (Number)

时间窗: 3 Months

Medication errors regarding frequency or dose of Sodium valproate

Adherence (Number)

时间窗: 3 Months

Adherence to medication regimens

Valproate dose (Number)

时间窗: 3 month

Right dose

Number of drugs (Number)

时间窗: 3 Months

Number of drugs included in the prescriptions analyzed

Tolerability (Number)

时间窗: 3 Months

tolerability was assessed through monitoring of ADRs and recorded in the patient's file.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Werida

Principal Investigator

Damanhour University

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