Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:29 AM
Study NCT ID:
NCT01341093
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2011-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Program for Cardiac Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in perceived health status at six months', 'timeFrame': 'baseline and six months', 'description': 'The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992) will be used to collect the data at baseline and at six months.'}], 'secondaryOutcomes': [{'measure': 'change from baseline in treatment adherence at six months', 'timeFrame': 'baseline and six months', 'description': 'The questionnaire "Medida de adesão ao tratamento (MAT)" developed by Delgado and Lima (2001) will be used to collect the data related to the pharmacological adherence at baseline and at six months.'}, {'measure': 'change from baseline in self-efficacy at six months', 'timeFrame': 'baseline and six months', 'description': 'The questionnaire "General Self-Efficacy Scale" developed by Schwarzer and Jerusalem (1995) will be used to collect the data at baseline and at six months.'}, {'measure': 'change from baseline in anxiety and depression at six months', 'timeFrame': 'baseline and six months', 'description': 'The questionnaire "Hospital Anxiety and Depression Scale (HADS)" developed by Zigmond and Snaith (1983) will be used to collect the data at baseline and at six months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25400127', 'type': 'DERIVED', 'citation': 'Furuya RK, Arantes EC, Dessotte CA, Ciol MA, Hoffman JM, Schmidt A, Dantas RA, Rossi LA. A randomized controlled trial of an educational programme to improve self-care in Brazilian patients following percutaneous coronary intervention. J Adv Nurs. 2015 Apr;71(4):895-908. doi: 10.1111/jan.12568. Epub 2014 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years or more) of both sexes\n* Being submitted to the first coronary artery bypass graft surgery between April 2011 and July 2012\n* Having a properly functioning residential phone line\n\nExclusion Criteria:\n\n* No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)\n\n * Illiterate participants who did not reach the minimum score 13 on the MMSE\n * Participants with one to seven years of education who did not reach the minimum score 18 on the MMSE\n * Participants with eight or more years of education who did not reach the minimum of 26 points on the MMSE'}, 'identificationModule': {'nctId': 'NCT01341093', 'briefTitle': 'Education Program for Cardiac Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2010/19761-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'interventionNames': ['Behavioral: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'educational program+telephone follow up', 'interventionNames': ['Behavioral: educational program+telephone follow up']}], 'interventions': [{'name': 'educational program+telephone follow up', 'type': 'BEHAVIORAL', 'description': 'Patients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months.', 'armGroupLabels': ['educational program+telephone follow up']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Patients will receive orientations about the surgery and the rehabilitation by health professionals, especially in the discharge. And will have return for evaluation scheduled by health professionals.', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Rejane K. Furuya, PhDCandidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of São Paulo at Ribeirão Preto College of Nursing'}, {'name': 'Lidia A. Rossi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of São Paulo at Ribeirão Preto College of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Rejane Kiyomi Furuya', 'investigatorAffiliation': 'University of Sao Paulo'}}}}