Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-19 @ 7:14 PM
Study NCT ID:
NCT02415751
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2015-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of hospitalizations', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'ejection fraction', 'timeFrame': '12 months'}, {'measure': 'change in heart failure medication knowledge', 'timeFrame': '12 months', 'description': 'Adapted from the Atlanta Heart Failure Knowledge Test V2 (AHFKT-VT) (Miller Reilly C 2009) Grading: 1 point for correct answer, 0 points for incorrect or skipped Total points and divide by 6 for percentage score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study is assessing the effects of a new heart failure self-care education program in the Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of an initial intensive self-care education session with the Principal Investigator or her nurse practitioner. Topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as studies have shown that the impact of HF education is not always durable and must be a continual process. This study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.', 'detailedDescription': 'This is an observational study as all patients in the heart failure clinic, regardless of whether or not they will choose to be in the study, will receive heart failure self-care education from now on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults ages 19 and older with heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 19 and older\n* Able to speak, read and understand English and able to understand and provide informed consent\n* Diagnosis of cardiomyopathy and/or HF, preserved or reduced ejection fraction\n\nExclusion Criteria:\n\n* Patients not-responsible for self-care.\n* Inability to provide written informed consent.\n* Co-morbid condition with an expected survival of less than six months.'}, 'identificationModule': {'nctId': 'NCT02415751', 'briefTitle': 'The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes', 'orgStudyIdInfo': {'id': '742726-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'self-care education', 'description': 'All patients in the study will receive self-care education', 'interventionNames': ['Behavioral: heart failure self-care education']}], 'interventions': [{'name': 'heart failure self-care education', 'type': 'BEHAVIORAL', 'description': 'It is defined as a naturalistic decision-making process that patients use in the choice of behaviors that maintain physiological stability (symptom monitoring and treatment adherence) and the response to symptoms when they occur (Riegel 2004). This includes following advice regarding medications, sodium and water consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms.', 'armGroupLabels': ['self-care education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68526', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68178', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Katie Packard, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHI Nebraska Heart', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Investigator', 'investigatorFullName': 'Katie Packard', 'investigatorAffiliation': 'Creighton University'}}}}