NCT02165306

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

June 13, 2014

Last Update Submit

February 5, 2015

Conditions

Epilepsy

Keywords

epilepsy

Outcome Measures

Primary Outcomes (1)

  • changes in Patient-reported medication Adherence to antiepileptic drugs

    The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to antiepileptic drugs

    changes from baseline , 3 Months and 6 months after the intervention

Secondary Outcomes (7)

  • changes in serum levels of antiepileptic drugs

    changes from baseline , 6 Months, 12 months and 18 months after the interventio

  • Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)

    Changes from baseline, 3 Months and 6 months after the intervention

  • Changes in action planning

    Changes from baseline, 3 Months and 6 months after the intervention

  • Changes in coping planning

    Changes from baseline, 3 Months and 6 months after the intervention

  • Changes in quality of life

    Changes from baseline, 3 Months and 6 months after the intervention

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Motivational Interviewing (MI)

Active Comparator

ACTIVE COMPARATOR

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

Behavioral: Routine counseling

Interventions

Motivational Interviewing (MI)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

Also known as: facilitate behavior change
Intervention
Routine counselingBEHAVIORAL

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.

Active Comparator

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qazvin University of Medical Sciences, Shahid Rajaei Hospital

Qazvin, Qazvin Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 33089492DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amir H pakpour, PhD

    Qazvin University Of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice chancellor for research

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

IR(1)