Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT07022067
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVOLVING AZIMUTH IN MUSA CONTEXT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAM13-I', 'timeFrame': '6 months', 'description': 'The Patient Activation Measure (PAM13-I) is a brief, validated instrument that assesses patient knowledge, skills, and confidence for disease self-management. It consists of 13 items on a Likert scale. According to the American version of PAM 13, each item has five response categories with scores from 1 to 5: (1) "Strongly Disagree", (2) "Disagree", (3) "Agree", (4) "Strongly Agree" and (5) "Not Applicable". The instrument design reflects the four stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important: items 1 and 2), level 2 (patients have confidence and knowledge to take action: items 3-8) level 3 (taking action: items 9-11) and level 4 (staying on course under stress: items 12 and 13).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Blood Pressure', 'Weight Change', 'Telemonitoring']}, 'descriptionModule': {'briefSummary': 'Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure', 'detailedDescription': 'The patient diagnosed with heart failure is randomized to either the experimental or control arm. The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. Patients from both arms complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with chronic CS according to the ESC guidelines;\n* Over 18 years of age;\n* Patients admitted to hospital or with access to first aid within the last year;\n* Smartphome that meets the digital requirements (ie Android or iOS able to download and use the application);\n* Wi-Fi or 3G coverage at home;\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Severe psychiatric disorder\n* Inability to use portable technologies\n* Patients unable to use the equipment provided\n* Patients who deny consent to study participation'}, 'identificationModule': {'nctId': 'NCT07022067', 'acronym': 'AZIMUSA', 'briefTitle': 'EVOLVING AZIMUTH IN MUSA CONTEXT', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'EVOLVING AZIMUTH IN MUSA CONTEXT', 'orgStudyIdInfo': {'id': '4372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemonitoring', 'description': 'The patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.', 'interventionNames': ['Device: Telemonitoring app']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'The patient in the standard care arm do not downloads a telemonitoring application, but they continue with normal medical indication. The patient complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.'}], 'interventions': [{'name': 'Telemonitoring app', 'type': 'DEVICE', 'description': 'periodic measurement of blood pressure and body weight', 'armGroupLabels': ['Telemonitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Prof. Carugo', 'role': 'CONTACT', 'email': 'stefano.carugo@policlinico.mi.it', 'phone': '+390255033532'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Stefano Prof. Carugo', 'role': 'CONTACT', 'email': 'stefano.carugo@policlinico.mi.it', 'phone': '+390255033532'}], 'overallOfficials': [{'name': 'Stefano Prof. Carugo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Fondazione Caì Granda Ospedale Maggiore Policlinico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'ASST Grande Ospedale Metropolitano Niguarda', 'class': 'OTHER'}, {'name': 'University of Milan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Cardio-Thoracic-Vascular Diseases', 'investigatorFullName': 'Stefano Carugo', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}