EpilepsyNCT02165306
Enhancing Antiepileptic Drug Adherence
A study testing Motivational Interviewing (MI) and Routine counseling in people with Epilepsy, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Motivational Interviewing (MI) and Routine counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIran
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Qazvin University of Medical Sciences, Shahid Rajaei Hospital
Qazvin, Qazvin Province
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Motivational Interviewing (MI), Routine counseling
- Keywords
- epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
Also called facilitate behavior change
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
Routine counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence Receives: Behavioral: Motivational Interviewing (MI) |
| Active Comparator | Active comparator | Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses. Receives: Behavioral: Routine counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: changes from baseline , 3 Months and 6 months after the intervention
Secondary outcomes (7)
changes in serum levels of antiepileptic drugs
Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity
Measured: 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)
Measured: Changes from baseline, 3 Months and 6 months after the intervention
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
Measured: Changes from baseline, 3 Months and 6 months after the intervention
Changes in coping planning
Measured: Changes from baseline, 3 Months and 6 months after the intervention
Changes in quality of life
Measured: Changes from baseline, 3 Months and 6 months after the intervention
Changes in habit strength
Measured: Changes from baseline, 3 Months and 6 months after the intervention
Changes in Seizure Severity
Measured: Changes from baseline, 3 Months and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
- Investigators
- Amir H pakpour, PhD, Principal investigator, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165306
- Sponsor's protocol ID
- 214588
- Status last verified
- Feb 2015
- First submitted
- 13 Jun 2014
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33089492
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Antiepileptic Drug Adherence
- ClinicalTrials.gov ID
- NCT02165306
- Acronym / sponsor ID
- 214588
- Conditions
- Epilepsy
- Keywords
- epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational Interviewing (MI)Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence |
| Active Comparator | Active comparator | Behavioral: Routine counselingUsual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing (MI)Also: facilitate behavior changeA 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 | Behavioural | Intervention |
| Routine counselingAll 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. | Behavioural | Active Comparator |
Primary outcome
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
7 secondary outcomes
changes in serum levels of antiepileptic drugs
Time frame: 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)
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Changes in action planning
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Changes in coping planning
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Changes in quality of life
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Changes in habit strength
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Changes in Seizure Severity
Time frame: Changes from baseline, 3 Months and 6 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 33089492Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir H pakpour, PhD principal investigator
Qazvin University Of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) and Routine counseling in people with Epilepsy, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in Patient-reported medication Adherence to antiepileptic drugs (time frame: changes from baseline , 3 Months and 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.