Enhancing Antiepileptic Drug Adherence

NCT ID: NCT02165306

Last Updated: 2015-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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More than half of patients with epilepsy achieve full control of their seizures with antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational intervention in improving medication adherence in patients with epilepsy.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence

Group Type EXPERIMENTAL

Motivational Interviewing (MI)

Intervention Type BEHAVIORAL

A multifaceted intervention program was used to improve adherence and clinical outcomes in epileptic patients. However, this study mainly focused on behavioral treatment in the patients.

Patient's intervention A three-week session will perform to improve medication adherence in patients in the intervention group. Face to face introductory motivational interviews (MI) will conduct to resolve patient ambivalence about change.

Besides providingthe intervention for the patients, the health care team and the patient's family member will receive a brief intervention.All GPs and nurses as well as patients' family members participate in a single session MI with the same procedure

Active Comparator

Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.

Group Type ACTIVE_COMPARATOR

Routine counseling

Intervention Type BEHAVIORAL

All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 5 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use.

Interventions

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Motivational Interviewing (MI)

A multifaceted intervention program was used to improve adherence and clinical outcomes in epileptic patients. However, this study mainly focused on behavioral treatment in the patients.

Patient's intervention A three-week session will perform to improve medication adherence in patients in the intervention group. Face to face introductory motivational interviews (MI) will conduct to resolve patient ambivalence about change.

Besides providingthe intervention for the patients, the health care team and the patient's family member will receive a brief intervention.All GPs and nurses as well as patients' family members participate in a single session MI with the same procedure

Intervention Type BEHAVIORAL

Routine counseling

All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 5 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use.

Intervention Type BEHAVIORAL

Other Intervention Names

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facilitate behavior change

Eligibility Criteria

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Inclusion Criteria

* diagnosis of epilepsy according to the International League Against Epilepsy criteria
* age equal or higher than 18 years
* independence in daily living activities
* absence of major cognitive impairment or active psychiatric disorders

Exclusion Criteria

* presence of a rapidly progressing neurological or medical disorder
* patients not receiving anti-epileptic drugs
* a history of significant substance abuse within the past year
* a diagnosis of mental retardation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir H Pakpour

vice chancellor for research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir H pakpour, PhD

Role: PRINCIPAL_INVESTIGATOR

Qazvin University Of Medical Sciences

Locations

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Qazvin University of Medical Sciences, Shahid Rajaei Hospital

Qazvin, Qazvin Province, Iran

Site Status

Countries

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Iran

References

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Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.

Reference Type DERIVED
PMID: 33089492 (View on PubMed)

Other Identifiers

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214588

Identifier Type: -

Identifier Source: org_study_id

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