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Enhancing Antiepileptic Drug Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02165306
Enrollment
280
Registered
2014-06-17
Start date
2014-06-30
Completion date
Unknown
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy

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.

Interventions

BEHAVIORALMotivational 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

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.

Sponsors

Qazvin University Of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in Patient-reported medication Adherence to antiepileptic drugschanges from baseline , 3 Months and 6 months after the interventionThe Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to antiepileptic drugs

Secondary

MeasureTime frameDescription
changes in serum levels of antiepileptic drugschanges from baseline , 6 Months, 12 months and 18 months after the interventioSerum 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 from baseline, 3 Months and 6 months after the intervention
Changes in action planningChanges from baseline, 3 Months and 6 months after the interventionThe number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention
Changes in habit strengthChanges from baseline, 3 Months and 6 months after the intervention
Changes in quality of lifeChanges from baseline, 3 Months and 6 months after the intervention
Changes in Seizure SeverityChanges from baseline, 3 Months and 6 months after the intervention
Changes in coping planningChanges from baseline, 3 Months and 6 months after the intervention

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026