Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT06146803
Status:
UNKNOWN
Last Update Posted:
2024-02-23
First Post:
2023-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the "Level of Resilience" Influencing Self-care in Heart Failure Patients
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': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate levels of resilience in subjects suffering from heart failure', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate levels of self-care in subjects suffering from heart failure', 'timeFrame': '12 months'}, {'measure': 'Evaluate the correlation between the level of resilience and the level of self-care', 'timeFrame': '12 months'}, {'measure': 'Evaluate which characteristics positively influence the level of resilience and the degree of self-care of patients with heart failure', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'Adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones', 'detailedDescription': 'Primary objective\n\n-Evaluate levels of resilience in subjects suffering from heart failure.\n\nSecondary objectives\n\n* Evaluate the levels of self-care in subjects suffering from heart failure.\n* Evaluate the correlation between the level of resilience and the level of self-care;\n* Evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure.\n\nConsecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients suffering from heart failure followed at the Cardiology department of the Agostino Gemelli IRCCS University Polyclinic Foundation of Rome will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects suffering from heart failure;\n* Subject aged between \\>18 years and \\<90 years;\n* Ability to understand the Italian language;\n* Clinical conditions that allow the questionnaire to be completed;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects suffering from other forms of diabetes;\n* Subjects suffering from serious psychiatric disorders;\n* Serious clinical conditions that do not allow the questionnaire to be completed;\n* Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT06146803', 'briefTitle': 'the "Level of Resilience" Influencing Self-care in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'How Much the "Level of Resilience" Influences Self-care in a Group of Subjects Suffering From Heart Failure: Observational, Cross-sectional Study', 'orgStudyIdInfo': {'id': '6079'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'NADIA ASPROMONTE, Prof.', 'role': 'CONTACT', 'email': 'nadia.aspromonte@policlinicogemelli.it', 'phone': '0630154851'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCSS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'NADIA ASPROMONTE, Prof.', 'role': 'CONTACT', 'email': 'nadia.aspromonte@policlinicogemelli.it', 'phone': '0630154851'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}