Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 2:39 PM
Study NCT ID:
NCT01308866
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2011-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-02', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk reduction', 'timeFrame': 'one year', 'description': 'Cardiovascular risk reduction measured throught REGICOR Spanish scale'}], 'secondaryOutcomes': [{'measure': 'Life self-perceived quality', 'timeFrame': 'one year', 'description': 'Throught questionnaire SF-12'}, {'measure': 'Anxiety and depression', 'timeFrame': 'one year', 'description': 'Throught HADS scale'}, {'measure': 'Decision empowerment', 'timeFrame': 'one year', 'description': "Otawa's decision scale"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiovascular diseases', 'patient education', 'primary health care', 'consumer participation', 'decision aids'], 'conditions': ['Hypercholesterolemia', 'Cardiovascular Risk']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.\n\nMETHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (\\>200 mg/dl or c-LDL\\>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007.\n\nRESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care.\n\nCONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers.\n* Patients who allow to participate in this study\n\nExclusion Criteria:\n\n* Patients with mental disorders.\n* Secundary cardiovascular risk patients'}, 'identificationModule': {'nctId': 'NCT01308866', 'acronym': 'PLEGATS', 'briefTitle': 'Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients', 'orgStudyIdInfo': {'id': 'PLEGATS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention arm using a share-decision tool for cardiovascular patients', 'interventionNames': ['Behavioral: Share decision tool']}], 'interventions': [{'name': 'Share decision tool', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Capse-Gesclínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08860', 'city': 'Castelldefels', 'country': 'Spain', 'facility': 'Cap El Castell', 'geoPoint': {'lat': 41.27794, 'lon': 1.97033}}], 'overallOfficials': [{'name': 'Joan Gene-Badia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona, CAPSE, Health Policy Monitor'}, {'name': 'Patricia Fernandez-Vandellos, RN, MpH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Preventive Services and Health Promotion Research Network', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Joan Gene Badia', 'oldOrganization': 'University of Barcelona'}}}}