Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 6:46 PM
Study NCT ID:
NCT01449695
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention to Improve Medication Adherence in Cardiovascular Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in degree of Adherence', 'timeFrame': 'Change from baseline in degree of Adherence at 12 month', 'description': 'The degree of Adherence to medication for each group at 12 month from baseline, as calculated by prescription refill data'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': 'Change from baseline in level of LDL-Cholesterol at 12 months', 'description': 'Change in LDL-Cholesterol level in each group at 12 months from baseline'}, {'measure': 'Clinical outcome', 'timeFrame': 'Change from baseline in Sytolic Blood Pressure at 12 months', 'description': 'Change in Systolic Blood Pressure in each group at 12 months from baseline'}, {'measure': 'Clinical outcome', 'timeFrame': 'Change from baseline in Body Mass Index at 12 months', 'description': 'Change in Body Mass Index (BMI) in each group at 12 months from baseline'}, {'measure': 'Clinical outcome', 'timeFrame': 'Change from baseline in Waist Circumference at 12 months', 'description': 'Change in Waist Circumference in each group at 12 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PAD', 'CVA', 'ACS'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '31213778', 'type': 'DERIVED', 'citation': 'Sieben A, van Onzenoort HA, van Dulmen S, van Laarhoven C, Bredie SJ. A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial. Patient Prefer Adherence. 2019 May 23;13:837-852. doi: 10.2147/PPA.S197481. eCollection 2019.'}, {'pmid': '27624877', 'type': 'DERIVED', 'citation': 'Sieben A, van Onzenoort HA, van Laarhoven KJ, Bredie SJ. A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial. JMIR Res Protoc. 2016 Sep 13;5(3):e187. doi: 10.2196/resprot.5750.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients.', 'detailedDescription': "Poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. As a consequence the risk of premature death, hospital admissions and related costs is increasing. Therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time.\n\nThis study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). Adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/TIA) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia.\n\nExclusion Criteria:\n\n* Age below 18 years, actual pregnancy, problems with Dutch language or logistic problems, which may hinder intervention on adherence behavior. Severe co-morbidity, including mental handicap, according to their physician.'}, 'identificationModule': {'nctId': 'NCT01449695', 'briefTitle': 'Intervention to Improve Medication Adherence in Cardiovascular Patients', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Nurse- and Web Based Intervention to Improve Medication Adherence in High Risk Cardiovascular Patients.', 'orgStudyIdInfo': {'id': '34338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Group consultation and individual nurse consultation', 'interventionNames': ['Behavioral: Life style counseling', 'Behavioral: an individualized web portal', 'Behavioral: individual and group consultations']}, {'type': 'EXPERIMENTAL', 'label': 'e health', 'description': 'An individual web based entry', 'interventionNames': ['Behavioral: an individualized web portal']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'Usual care'}], 'interventions': [{'name': 'Life style counseling', 'type': 'BEHAVIORAL', 'description': 'A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes.', 'armGroupLabels': ['Lifestyle counseling']}, {'name': 'an individualized web portal', 'type': 'BEHAVIORAL', 'description': "This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient.", 'armGroupLabels': ['Lifestyle counseling', 'e health']}, {'name': 'individual and group consultations', 'type': 'BEHAVIORAL', 'description': 'group consultations with peers and a nurse individual consultation with a nurse', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University medical centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Bas JH Bredie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bas Bredie', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}