Enhancing Antiepileptic Drug Adherence
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Motivational Interviewing (MI)
Routine counseling
Sponsored by
About this trial
This is an interventional health services research trial for Epilepsy focused on measuring epilepsy
Eligibility Criteria
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
Sites / Locations
- Qazvin University of Medical Sciences, Shahid Rajaei Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Active Comparator
Arm Description
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
changes in serum levels of antiepileptic drugs
Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity
Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)
Changes in action planning
The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention
Changes in coping planning
Changes in quality of life
Changes in habit strength
Changes in Seizure Severity
Full Information
NCT ID
NCT02165306
First Posted
June 13, 2014
Last Updated
February 5, 2015
Sponsor
Qazvin University Of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02165306
Brief Title
Enhancing Antiepileptic Drug Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Other Intervention Name(s)
facilitate behavior change
Intervention Description
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
Intervention Name(s)
Routine counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in Patient-reported medication Adherence to antiepileptic drugs
Description
The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to antiepileptic drugs
Time Frame
changes from baseline , 3 Months and 6 months after the intervention
Secondary Outcome Measure Information:
Title
changes in serum levels of antiepileptic drugs
Description
Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity
Time Frame
changes from baseline , 6 Months, 12 months and 18 months after the interventio
Title
Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
Title
Changes in action planning
Description
The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
Title
Changes in coping planning
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
Title
Changes in quality of life
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
Title
Changes in habit strength
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
Title
Changes in Seizure Severity
Time Frame
Changes from baseline, 3 Months and 6 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir H pakpour, PhD
Organizational Affiliation
Qazvin University Of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qazvin University of Medical Sciences, Shahid Rajaei Hospital
City
Qazvin
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33089492
Citation
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.
Results Reference
derived
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Enhancing Antiepileptic Drug Adherence
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