Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-04 @ 8:44 PM
Study NCT ID:
NCT02927808
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2016-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-15', 'studyFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of low-density lipoprotein cholesterol therapeutic goal, as specified by current practice guidelines (LDL-C <70 mg/dL or >50% reduction from baseline LDL-C)', 'timeFrame': '12 months after discharge from hospital'}], 'secondaryOutcomes': [{'measure': 'Overall adherence to lipid-lowering regimen, reported as both a continuous and a binary outcome, by using the 4-item Morisky Medication-Taking Adherence Scale', 'timeFrame': '12 months after discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Motivational Interviewing', 'LDL-C', 'LDL target', 'Medication adherence'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '35345248', 'type': 'DERIVED', 'citation': 'Kourti O, Konstantas O, Farmakis ITau, Zafeiropoulos S, Psarakis G, Vrana E, Baroutidou A, Graidis S, Touriki AV, Tsolakidis C, Spyridaki K, Psathas T, Daniilidou A, Karvounis H, Giannakoulas G. Potent P2Y12 inhibitors versus clopidogrel to predict adherence to antiplatelet therapy after an acute coronary syndrome: insights from IDEAL-LDL. Rev Cardiovasc Med. 2022 Mar 3;23(3):81. doi: 10.31083/j.rcm2303081.'}, {'pmid': '33780749', 'type': 'DERIVED', 'citation': 'Zafeiropoulos S, Farmakis I, Kartas A, Arvanitaki A, Pagiantza A, Boulmpou A, Tampaki A, Kosmidis D, Nevras V, Markidis E, Papadimitriou I, Vlachou A, Arvanitakis K, Miyara SJ, Ziakas A, Molmenti EP, Kassimis G, Zanos S, Karvounis H, Giannakoulas G. Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial. Atherosclerosis. 2021 Apr;323:37-43. doi: 10.1016/j.atherosclerosis.2021.03.013. Epub 2021 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the impact of motivational interviewing in achieving low-density lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.', 'detailedDescription': 'To determine whether a strategy of enhanced information about the risks of high plasma low-density lipoprotein cholesterol (LDL-C) and the importance of lipid-lowering medication together with close follow-up and motivational interviewing is superior than usual care in achieving LDL-C therapeutic targets, as set by current practice guidelines (LDL-C \\<70 mg/dL or \\>50% reduction from baseline LDL-C) in patients with acute coronary syndromes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject hospitalized for acute coronary syndrome (STEMI, NTEMI or unstable angina)\n* Subject currently on lipid-lowering therapy or prescribed lipid-lowering therapy at hospital discharge (statins and/or other agents)\n* Subject who is 18 years or older\n* Subject or legally authorized representative who is willing and capable of providing informed consent, participating in all associated study activities\n\nExclusion Criteria:\n\n* Subject unable to communicate via telephone for study interviewing\n* Subject with contraindication to statin therapy\n* Subject with any medical disorder that would interfere with completion or evaluation of clinical study results'}, 'identificationModule': {'nctId': 'NCT02927808', 'acronym': 'IDEAL-LDL', 'briefTitle': 'Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'AHEPA University Hospital'}, 'officialTitle': 'Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study', 'orgStudyIdInfo': {'id': '22904/25.5.2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group - Motivational Interview', 'description': 'Patients assigned to the intervention group will be given a leaflet entitled "Information leaflet about LDL Cholesterol" that will educate them about the risks of high LDL-C and the importance of adherence to lipid-lowering medication. Patients assigned to the intervention group will be contacted via telephone for a pre-specified interview (motivational interview again stressing the importance of adherence to lipid-lowering medication) at 1 month and 6 months after discharge, and for an in-person interview plus lipid profiling at 1 year after discharge.', 'interventionNames': ['Behavioral: Motivational Interview']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients assigned to the control group will be contacted for a pre-specified in-person interview plus lipid profiling at 1 year after discharge.'}], 'interventions': [{'name': 'Motivational Interview', 'type': 'BEHAVIORAL', 'description': 'Informational leaflet about the risks of high LDL-C and the importance of adherence to lipid-lowering medication in patients with coronary artery disease. Follow-up motivational interviewing at 1 and 6 months after discharge.', 'armGroupLabels': ['Intervention group - Motivational Interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54636', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'AHEPA University Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHEPA University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Clinical Research Associate', 'investigatorFullName': 'Leonidas Lillis', 'investigatorAffiliation': 'AHEPA University Hospital'}}}}