Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-01-21 @ 8:12 PM
Study NCT ID:
NCT02165306
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Antiepileptic Drug Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in Patient-reported medication Adherence to antiepileptic drugs', 'timeFrame': 'changes from baseline , 3 Months and 6 months after the intervention', 'description': 'The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to antiepileptic drugs'}], 'secondaryOutcomes': [{'measure': 'changes in serum levels of antiepileptic drugs', 'timeFrame': 'changes from baseline , 6 Months, 12 months and 18 months after the interventio', 'description': 'Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity'}, {'measure': 'Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention'}, {'measure': 'Changes in action planning', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention', 'description': 'The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention'}, {'measure': 'Changes in coping planning', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention'}, {'measure': 'Changes in quality of life', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention'}, {'measure': 'Changes in habit strength', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention'}, {'measure': 'Changes in Seizure Severity', 'timeFrame': 'Changes from baseline, 3 Months and 6 months after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '33089492', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of epilepsy according to the International League Against Epilepsy criteria\n* age equal or higher than 18 years\n* independence in daily living activities\n* absence of major cognitive impairment or active psychiatric disorders\n\nExclusion Criteria:\n\n* presence of a rapidly progressing neurological or medical disorder\n* patients not receiving anti-epileptic drugs\n* a history of significant substance abuse within the past year\n* a diagnosis of mental retardation'}, 'identificationModule': {'nctId': 'NCT02165306', 'briefTitle': 'Enhancing Antiepileptic Drug Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'orgStudyIdInfo': {'id': '214588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence', 'interventionNames': ['Behavioral: Motivational Interviewing (MI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.', 'interventionNames': ['Behavioral: Routine counseling']}], 'interventions': [{'name': 'Motivational Interviewing (MI)', 'type': 'BEHAVIORAL', 'otherNames': ['facilitate behavior change'], '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.\n\nPatient'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.\n\nBesides 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", 'armGroupLabels': ['Intervention']}, {'name': 'Routine counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qazvin', 'state': 'Qazvin Province', 'country': 'Iran', 'facility': 'Qazvin University of Medical Sciences, Shahid Rajaei Hospital', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}], 'overallOfficials': [{'name': 'Amir H pakpour, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qazvin University Of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice chancellor for research', 'investigatorFullName': 'Amir H Pakpour', 'investigatorAffiliation': 'Qazvin University Of Medical Sciences'}}}}