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Completed

NCT Number: NCT02165306

Enhancing Antiepileptic Drug Adherence

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qazvin University of Medical Sciences, Shahid Rajaei Hospital

Qazvin, Qazvin Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: facilitate behavior change

Routine counseling

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.

Primary outcomes

  1. changes in Patient-reported medication Adherence to antiepileptic drugs

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

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

Secondary outcomes

  1. changes in serum levels of antiepileptic drugs

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

    Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity

  2. 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

  3. Changes in action planning

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

    The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention

  4. Changes in coping planning

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

  5. Changes in quality of life

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

  6. Changes in habit strength

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

  7. Changes in Seizure Severity

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

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
Jun 17, 2014
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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