NCT04967326

Brief Summary

Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

July 8, 2021

Last Update Submit

July 25, 2021

Conditions

Keywords

epilepsyrole of pharmacistadverse drug reactionantiepileptic drugVietnam

Outcome Measures

Primary Outcomes (1)

  • Number of patients with two seizures or less

    Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.

    One year from the start of the study

Secondary Outcomes (1)

  • Number of patients who maintained an optimized concentration of antiepileptic drugs

    One year from the start of the study

Study Arms (1)

Patients with epilepsy

EXPERIMENTAL

The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy.

Drug: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
  • were treated for more than one month.

You may not qualify if:

  • were pregnant or breastfeeding women.
  • had a history of alcoholism.
  • had liver or renal disease.
  • were using drugs known to have an influence on cytochrome P450 enzymes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pham HT, Tran MH, Nguyen NQ, Tan Vo V, Tran MH. Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study. J Pharm Policy Pract. 2021 Dec 20;14(1):109. doi: 10.1186/s40545-021-00394-9.

MeSH Terms

Conditions

EpilepsyDrug-Related Side Effects and Adverse Reactions

Interventions

AnticonvulsantsCarbamazepinePhenytoinValproic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical pharmacist

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 2, 2021

Record last verified: 2021-07