Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-02-22 @ 12:35 AM
Study NCT ID:
NCT02230150
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2014-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-29', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'performance in the six minutes walk test', 'timeFrame': '1 month', 'description': 'monitor the difference in performance of the 6-minute walk test in adherent and non-adherent'}], 'primaryOutcomes': [{'measure': 'ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE', 'timeFrame': '1 month', 'description': 'Verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.'}], 'secondaryOutcomes': [{'measure': 'changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine', 'timeFrame': '1 month', 'description': 'changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine before and after nursing consultation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adhesion, Knowledge, Nursing'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.', 'detailedDescription': '1. Characterize the socio-demographic and clinical aspects of heart failure patients;\n2. Awareness before and after nursing consultation, in relation to diet for heart failure, liquid and weight, general heart failure information, medication, physical activity, measures to improve disease control, signs of decompensated heart failure;\n3. Adhesion of patients before and after nursing consultation, related to medication, liquid and weight, use of alcohol and importance of returning for consultation and exams.\n4. Evaluated the impact of educational intervention at the levels of NT-proBNP, urea, creatinine, sodium, potassium, before and after nursing consultation;\n5. The 6 minute walk test performance before and after nursing consultation;\n6. The distance covered and time of the 6 minute walk test, until fatigue in heart failure patients before and after nursing consultation;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* During the first phase of the study all the heart failure patients with ventricular ejection fraction of up to 49% shall be included (confirmed through ECOTT performed during the past year). All patients inserted had systolic heart failure and were scheduled and which agreed to take part of the research, signing a term of informed consent.\n\nExclusion Criteria:\n\n* Individuals with cognitive deficit, first outpatient medical consultation, suffered AMI (acute myocardial infarction) within the last 3 months or a stroke, post-operative of cardiac surgery, patients with chronic obstructive pulmonary disease (COPD), orthopedic problems, patients over the age of 80 and those that do not accept to participate of the research.'}, 'identificationModule': {'nctId': 'NCT02230150', 'acronym': 'ADhesion-HF', 'briefTitle': 'ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': 'ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF', 'orgStudyIdInfo': {'id': 'ADhesion-HF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adhesion-HF', 'type': 'BEHAVIORAL', 'description': 'The hypothesis that was investigated is whether the nursing consultation improves therapeutic strategies for membership, adherence to self-care, improved levels of NT-proBNP improves performance in 6-minute walk test, monitoring of biomarkers of laboratory tests (sodium , potassium, urea, creatinine and NT-proBNP) frequent occurrence of readmissions and mortality in patients with heart failure after 1 month.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41120-700', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Ana Nery', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Márcia M Carneiro Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE', 'investigatorFullName': 'Márcia Maria Carneiro Oliveira', 'investigatorAffiliation': 'Federal University of Bahia'}}}}