Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-04-15 @ 11:18 AM
Study NCT ID:
NCT05422859
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of the application', 'timeFrame': '3 months', 'description': 'The acceptence of the application will be measured by the User Experience Questionnaire. It consists of 9 items that can be rated on a 7-point Likert scale. -3 (fully agree with negative term) to +3 (fully agree with positive term). A higher total score means a better outcome.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline and 3 months', 'description': 'Quality of life measured by Kansas City Cardiomyopathy Questionnaire using the validated 12-item version which has been described by Spertus et Jones (doi: 10.1161/CIRCOUTCOMES.115.001958.) A higher score means a better outcome.'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'Baseline and 3 months', 'description': 'Health-related quality of life will be measured by the "Patient Related Outcome and Measurement Information System" (PROMIS) test. Including 23 items that will be analyzed via Likert scale 1 (impossible/never) to 5 (no limitations/very good). A higher score means a better outcome.'}, {'measure': 'Change in symptoms of heart failure', 'timeFrame': 'Baseline and 3 months', 'description': 'Symptoms of heart failure will be assessed by the New York Heart Association functional class. Consisting of four classes (I-IV), the higher, the worse the outcome.'}, {'measure': 'Change in six-minute walk distance', 'timeFrame': 'Baseline and 3 months', 'description': 'Functional capacity will be assessed by the 6-minute walk test'}, {'measure': 'Change in daily walking distances', 'timeFrame': 'Baseline and 3 months', 'description': 'Functional capacity will be assessed by the steps taken within 24 hours (pedometry).'}, {'measure': 'Change in heart failure biomarker', 'timeFrame': 'Baseline and 3 months', 'description': 'Heart failure severity will be assessed by the biomarker NT-proBNP.'}, {'measure': 'Number of hospitalizations', 'timeFrame': '3 months', 'description': 'Number of hospitalizations for heart failure will be assessed.'}, {'measure': 'Length of hospitalizations', 'timeFrame': '3 months', 'description': 'Length of in-hospital stay of hospitalizations for heart failure will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The MobiDig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified Heart Failure Unit centers in Berlin and Brandenburg.\n\nThe aim is to evaluate the effect on quality of life, symptoms and the course of the disease. In addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of heart failure\n* Treatment in a certified Heart Failure Unit center in Berlin or Brandenburg\n* Written informed consent of the participants\n* User of a mobile device with an iOS operating system\n\nExclusion Criteria:\n\n* Addiction or other illnesses that do not allow the participants to assess the nature and scope as well as possible consequences of participation or its scientific evaluation\n* insufficient knowledge of the German language, which is necessary to use the application'}, 'identificationModule': {'nctId': 'NCT05422859', 'acronym': 'MobiDig', 'briefTitle': 'Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg', 'organization': {'class': 'OTHER', 'fullName': 'German Heart Institute'}, 'officialTitle': 'Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg', 'orgStudyIdInfo': {'id': 'MobiDig'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MobiDig', 'description': '50 patients will have access to a mobile phone application for 3 months.', 'interventionNames': ['Other: MobiDig']}], 'interventions': [{'name': 'MobiDig', 'type': 'OTHER', 'description': 'The application will contain the following modules:\n\n1. information and knowledge about heart failure;\n2. vital sign diary, which can be sent to the certified HFU\n3. pedometer (individualized step-goal), cardiac home training videos\n4. "frequently asked questions" and connection to a certified HFU provider by a heart failure hotline', 'armGroupLabels': ['MobiDig']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'Deutschland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Isabell A Just, Dr.', 'role': 'CONTACT', 'email': 'ijust@dhzb.de', 'phone': '+493045932025'}, {'name': 'Felix Schoenrath, Prof. Dr.', 'role': 'CONTACT', 'email': 'schoenrath@dhzb.de', 'phone': '+493045932085'}], 'facility': 'Deutsches Herzzentrum der Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frank Edelmann, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Charité - Universitätsmedizin Berlin: Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bernau', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Herzzentrum Berlin', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}], 'centralContacts': [{'name': 'Isabell A Just, Dr.', 'role': 'CONTACT', 'email': 'ijust@dhzb.de', 'phone': '00493045932025'}, {'name': 'Felix Schoenrath, Prof. Dr.', 'role': 'CONTACT', 'email': 'schoenrath@dhzb.de', 'phone': '00493045932085'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal Ministry of Health, Germany', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Studienzentrale', 'investigatorFullName': 'Sabine Huebler', 'investigatorAffiliation': 'German Heart Institute'}}}}