Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04071093
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Telemonitoring System for Patients With Heart Failure
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in self-care', 'timeFrame': '3-month', 'description': 'Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire'}, {'measure': 'Changes in treatment adherence', 'timeFrame': '3-month', 'description': 'Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale'}], 'secondaryOutcomes': [{'measure': 'Rate of Rehospitalizations', 'timeFrame': '3-month', 'description': 'Rehospitalizations rate during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '31973633', 'type': 'DERIVED', 'citation': 'Yanicelli LM, Goy CB, Gonzalez VDC, Palacios GN, Martinez EC, Herrera MC. Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial. J Telemed Telecare. 2021 Oct;27(9):553-561. doi: 10.1177/1357633X19899261. Epub 2020 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* were over 18 years with a primary diagnosis of HF,\n* had been hospitalized at least once time as a consequence of a HF decompensation,\n* had a Smartphone,\n* had access to WiFi,\n* had access to a weight scale and to a blood-pressure monitor\n\nExclusion Criteria:\n\n* illiterate patients,\n* had learning difficulties,\n* had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.'}, 'identificationModule': {'nctId': 'NCT04071093', 'briefTitle': 'Home Telemonitoring System for Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Tucuman'}, 'officialTitle': 'Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad', 'orgStudyIdInfo': {'id': '94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Telemonitoring', 'interventionNames': ['Other: Home Telemonitoring System (HTS)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Home Telemonitoring System (HTS)', 'type': 'OTHER', 'description': 'The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.', 'armGroupLabels': ['Telemonitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Zenón Santillán Health Center Hospital', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}], 'overallOfficials': [{'name': 'Lucia M Yanicelli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Nacional de Tucumán'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Tucuman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD in Exact Sciences and Engineering', 'investigatorFullName': 'Lucía María Yanicelli', 'investigatorAffiliation': 'Universidad Nacional de Tucuman'}}}}