Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02102503
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing and Medication Review in Coronary Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090143', 'term': 'Medication Review'}], 'ancestors': [{'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Process measure: Quality of prescribing, for a random sample of 20 % of patients', 'timeFrame': '6 months', 'description': 'According to Medication Assessment Tool for secondary prevention of Coronary Heart disease'}, {'measure': 'Process measure: What was delivered in the Medication review', 'timeFrame': '12 months, only intervention group', 'description': 'Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems.'}, {'measure': 'Process measure: Quality of MI, for a random sample of 20 % of consultations', 'timeFrame': '12 months', 'description': 'According to MITI 4.2.1'}, {'measure': 'Process measure: Beliefs about medicines - percent of patients per category', 'timeFrame': '16 months', 'description': 'Beliefs about medicines questionnaire (BMQ-S10), categories: accepting, ambivalent, neutral, skeptical. Also temporal cahnges in both Groups and Changes in each item of the subscales.'}, {'measure': 'Process measure: Intervention experienced by patients', 'timeFrame': '12 months', 'description': 'Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis.'}, {'measure': 'Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.', 'timeFrame': '16 months, for the last 100 patients to be included.', 'description': 'Open question: What is you opinion of the follow-up care after your heart disease?" Analysed with qualitative content analysis separetly for Control and intervention group patients.'}, {'measure': 'Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years', 'timeFrame': '16 months', 'description': 'Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L'}], 'primaryOutcomes': [{'measure': 'Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)', 'timeFrame': '16 months', 'description': 'According to Swedish guidelines the goal is \\< 1,8mmol/L or at least 50% reduction from baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients adherent to cholesterol lowering treatment', 'timeFrame': '16 months', 'description': 'Self-reported adherence according to Morisky-8-Item Adherence Scale'}, {'measure': 'Percentage of patients adherent to cholesterol lowering treatment', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients adherent to cholesterol lowering treatment', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, Percent Day Covered (PDC) during follow-up period, 80% is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients adherent to preventive medication: P2Y12-antagonist', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients adherent to preventive medication: Beta-blocker', 'timeFrame': '16 months', 'description': 'Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.'}, {'measure': 'Percentage of patients with Systolic Blood Pressure <140', 'timeFrame': '16 months', 'description': 'As registered in the Electronic Health Record'}, {'measure': 'Changes in Quality of Life', 'timeFrame': '16 months', 'description': 'The Heart QoL instrument'}, {'measure': 'Number of Cardiovascular Re-admissions and Emergency Department visits', 'timeFrame': '16 months', 'description': 'According to the Health Care register of Kalmar County'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '34334142', 'type': 'DERIVED', 'citation': 'Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Effects of a pharmaceutical care intervention on clinical outcomes and patient adherence in coronary heart disease: the MIMeRiC randomized controlled trial. BMC Cardiovasc Disord. 2021 Aug 1;21(1):367. doi: 10.1186/s12872-021-02178-0.'}, {'pmid': '29463490', 'type': 'DERIVED', 'citation': 'Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life. JMIR Res Protoc. 2018 Feb 20;7(2):e57. doi: 10.2196/resprot.8659.'}]}, 'descriptionModule': {'briefSummary': "Low medication adherence in patients with coronary heart disease increases mortality.\n\nThis study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.", 'detailedDescription': 'The study will investigate the effects of medication review and Motivational Interviewing (MI) on patients with Coronary Heart Disease (CHD). Clinical pharmacists competent in MI and cardiology will conduct medication interviews and medication reviews at the outpatient clinic. The intervention will continue during 9 months, with interviews and reviews as needed.\n\nFollow-up of results will take place 16 months after inclusion (corresponding to 4 months after the end of intervention).\n\nThe MI-Component will be quality assured by MITI 4.2-coding (Motivational Interviewing Treatment Integrity). The study will investigate effects on clinical outcomes, medication adherence, patients´ beliefs about medicines and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted for angiography\n* Verified Coronary Artery Disease (ICD-10 I20-I21)\n* Planned for follow up at the out-patient clinic (standard treatment)\n* Swedish speaking\n\nExclusion Criteria:\n\n* Cognitive impairment or any othe condition making interview or phone calls impossible.\n* Non-participation in the standard follow-up\n* Prior participation in this study'}, 'identificationModule': {'nctId': 'NCT02102503', 'acronym': 'MIMeRiC', 'briefTitle': 'Motivational Interviewing and Medication Review in Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'GLAS-1-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MI and Medication review', 'description': 'The intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.', 'interventionNames': ['Behavioral: Standard Treatment', 'Behavioral: MI and Medication review']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.', 'interventionNames': ['Behavioral: Standard Treatment']}], 'interventions': [{'name': 'Standard Treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['MI and Medication review', 'Standard treatment']}, {'name': 'MI and Medication review', 'type': 'BEHAVIORAL', 'armGroupLabels': ['MI and Medication review']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39182', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Kalmar County Hospital', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}], 'overallOfficials': [{'name': 'Göran Petersson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linnaeus University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göran Petersson', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Kamprad Family Foundation for Entrepreneurship, Research & Charity', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Health Informatics with focus on Pharmaceutical Science', 'investigatorFullName': 'Göran Petersson', 'investigatorAffiliation': 'Linnaeus University'}}}}