Pharmacist Impact on Use of Valproic Acid Therapy in Patients With Neurological Disorders

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT05830981
Collaborator
Mansoura University (Other)
600
36

Study Details

Study Description

Brief Summary

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 clinic of neurology department at Mansoura university teaching hospital were analyzed in a retrospective cohort 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational intervention

Detailed Description

This retrospective cohort study was conducted at the outpatient's clinics 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 patient were educated and followed up for six months.

Inclusion/ exclusion criteria: The study population was limited to those who 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. 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.

Study Design

Study Type:
Observational
Actual Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Pharmacist Impact on Use of Valproic Acid Therapy in Patients With Neurological Disorders: a Retrospective and Prospective Analysis
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 20, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Phase 1

n=600

Other: Educational intervention
3 months of educational intervention (Lectures) among professionals was given.
Other Names:
  • Lectures
  • Phase 2

    n=504

    Other: Educational intervention
    3 months of educational intervention (Lectures) among professionals was given.
    Other Names:
  • Lectures
  • Outcome Measures

    Primary Outcome Measures

    1. Valproate dose (Number) [3 month]

      Right dose

    2. Number of drugs (Number) [3 Months]

      Number of drugs included in the prescriptions analyzed

    3. Medication errors (Number) [3 Months]

      Medication errors regarding frequency or dose of Sodium valproate

    4. Adherence (Number) [3 Months]

      Adherence to medication regimens

    5. Tolerability (Number) [3 Months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 70 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • Patients who not use valproate.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Damanhour University
    • Mansoura University

    Investigators

    • Principal Investigator: Rehab H Werida, Ass. Prof., Damanhour University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rehab Werida, Principal Investigator, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05830981
    Other Study ID Numbers:
    • valproic acid therapy
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    May 2, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rehab Werida, Principal Investigator, Damanhour University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2023