Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT05750420
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2023-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Status and Self-care in Chronic Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological status and self-care', 'timeFrame': 'At the moment of enrollment', 'description': 'Investigating the relationship between psychological status and self-care in patients with chronic cardiovascular disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression', 'Emotional Stress', 'Quality of Life', 'Self-care', 'Chronic Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease', 'detailedDescription': '400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with chronic cardiovascular disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being aged \\> 18 years old and \\> 85 years old\n* Being diagnosed with a chronic cardiovascular disease\n* Being able and willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation\n* Not speaking Italian'}, 'identificationModule': {'nctId': 'NCT05750420', 'briefTitle': 'Psychological Status and Self-care in Chronic Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'CCM1789'}}, 'armsInterventionsModule': {'interventions': [{'name': 'There was no intervention, the study was a cross-sectional observational study', 'type': 'OTHER', 'description': 'Questionnaires for measuring self-care, anxiety, depression, emotinal distress and quality of live were administered to patients with chronic cardiovascular disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Monzino Cardiology Center', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'IRCCS San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}