Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT04294303
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Telemonitoring System 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of hospital readmission for heart failure', 'timeFrame': '45 days after enrollment'}], 'secondaryOutcomes': [{'measure': 'Quality of life: questioninaire', 'timeFrame': '45 days after enrollment', 'description': 'Quality of life based on Minnesota Living with Heart Failure Questionnaire, Range 0-105, from best to worst quality of life. First time given at time of enrollment and then 45 days after enrollment, a member of the research team contacted patient by phone to complete the questionnaire.'}, {'measure': 'Perceived effect of the intervention on heart-failure related care', 'timeFrame': '45 days after enrollment', 'description': 'Perceived effect of the intervention on heart-failure related care based on the Perceived effect of telemonitoring questionnaire. 45 days after enrollment, a member of the research team contacted patient by phone to complete the following questions :\n\n1. Felt more in the control of the disease\n2. Felt more connected with the medical team\n3. Felt that it reminded to take the pills\n\nEach question is answered on the following scale: very true, true, somewhat true, and not true at all.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Nationwide, approximately 25% of patients admitted to a hospital for heart failure are readmitted to a hospital within 30 days.Multiple transitional care interventions, including telemonitoring, aimed to decrease hospital readmission rates and improve quality of life in heart failure (HF) patients have been explored. Most studies evaluated effectiveness of telemonitoring used in conjunction with other interventions. In this study, investigators studied the role of a potentially cost-effective, telemonitoring program in reducing readmissions and improving quality of life among patients admitted with HF exacerbation in a teaching hospital. They aimed to determine impact of a standalone telemonitoring system.\n\nPrimary outcome: Rate of hospital readmission for heart failure Secondary outcomes: Quality of life, Perceived effect of the intervention on heart-failure related care', 'detailedDescription': "60 patients will be recruited for this study. After signing the consent form, participant will be randomized to receive usual care (i.e. they will get the current standard care for patients with heart failure) or usual care and participation in the iGetBetter program. Participant will complete a questionnaire in the hospital about their quality of life. iGetBetter group will be given a Bluetooth-equipped scale, blood pressure cuff, and a tablet with a data plan. Participant will check their weight and blood pressure at home daily, using the equipment provided. This information will be sent via the internet to iGetBetter's web server, where the data will be temporarily stored. The data will be monitored by the physician researcher. If their blood pressure is high (e.g. greater than or equal to 140/90 for two days in a row) or they gain a significant amount of weight (e.g. 2 pounds in two days), the study team will be automatically notified. A member of the study team will alert participant cardiologist and the cardiologist will have the option to make any recommendations, such as contacting the subject to schedule an office visit.\n\nTotal participation in this study will last 45 days after patient is discharged from the hospital.\n\nRegardless of the assigned group, participant will be asked to complete two questionnaires after 45 days. A member of the research team will contact participant by phone to complete these questionnaires. One of these questionnaires will investigate their quality of life; the other will assess how participant feel the care they have received has affected their health. Patients assigned to the iGetBetter group will also complete a third survey about their satisfaction with the program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Admitted to Danbury Hospital with heart failure\n* NYHA functional class II-IV\n\nExclusion Criteria:\n\n* Not agreeable to participate in the study\n* ESRD on HD\n* Severe COPD (O2/steroid dependent?)\n* Pregnancy\n* Hospice patients/bed bound patients\n* Severe valvular disease, or recent valvular intervention (within 1 year) or planned valvular intervention.\n* Expected to be transferred to another acute care hospital\n* Solid organ transplant recipient or listed for transplant, recipient of left ventricular assist device or planned to receive one\n* Homeless participants\n* Active psychiatric disorders, addiction'}, 'identificationModule': {'nctId': 'NCT04294303', 'acronym': 'I get better', 'briefTitle': 'Use of Telemonitoring System in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Danbury Hospital'}, 'officialTitle': 'Heart Failure Self-Management Using a Mobile Web-Based Telemonitoring System- Impact on Hospital Readmissions and Quality of Life SELF-e HF', 'orgStudyIdInfo': {'id': '15-608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemonitoring', 'description': 'Subjects were assigned to web based telemonitoring system.', 'interventionNames': ['Other: web based telemonitoring system']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Subjects were assigned to conventional monitoring.', 'interventionNames': ['Other: Conventional']}], 'interventions': [{'name': 'web based telemonitoring system', 'type': 'OTHER', 'description': 'Subjects in the telemonitoring group were given an iPad with installed iHealth application, a scale, and an electronic blood pressure monitor (a mobile web-based telemonitoring system). These devices were interconnected via Bluetooth. The iPad had permanent internet connection. Patients were taught to use the equipment to check and record their weight, blood pressure, and heart rate every morning, for 45 days after the hospital discharge. Data was automatically uploaded via iHealth application in a secure database.', 'armGroupLabels': ['Telemonitoring']}, {'name': 'Conventional', 'type': 'OTHER', 'description': 'Subjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Hospital', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}], 'overallOfficials': [{'name': 'Ira Galin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danbury Hospital, Nuvance Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danbury Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director of the vascular Medicine Program', 'investigatorFullName': 'Ira Galin', 'investigatorAffiliation': 'Danbury Hospital'}}}}