Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01975402
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2013-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-11-01', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Healthcare record integration', 'timeFrame': '12 months', 'description': 'Concurrently develop the infrastructure to support the back-end solution of the system including technician support, closed feedback loops to support care of the monitored subjects by an integrated team of health care providers, user-interfaces which display summarized data for the patient and other members of the healthcare team, and integration of summarized data into the Mayo electronic medical record.'}], 'primaryOutcomes': [{'measure': 'adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks', 'timeFrame': '12 months', 'description': 'To evaluate subject adherence, data transfer, clinical utilization and work-flow as well as perceptions and experiences of HF outpatients (n=30) and providers of the end-to-end remote monitoring system.'}], 'secondaryOutcomes': [{'measure': 'effect of end-to-end system on life quality', 'timeFrame': '12 months', 'description': 'Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congestive Heart Failure'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system', 'detailedDescription': 'The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals \\>50 years with Congestive Heart Failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients\n* Stable New York Heart Association Class I-III HF (defined as no admissions for \\> 1 year)\n* Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women\n* Age \\> 50 years\n* Reside in Olmsted County\n\nExclusion Criteria:\n\n* Hospital admission for HF within past year\n* Dementia\n* Overall life expectancy \\< 2 months\n* Blindness\n* Pregnancy or women able to become pregnant\n* Skin allergy to adhesives\n* Inadequate cell phone coverage (international patients or international travel during study period)\n* Documented Ejection Fraction of \\>40%'}, 'identificationModule': {'nctId': 'NCT01975402', 'acronym': 'R01-Aim2', 'briefTitle': 'Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population', 'orgStudyIdInfo': {'id': '13-005607'}, 'secondaryIdInfos': [{'id': 'R01AG041676', 'link': 'https://reporter.nih.gov/quickSearch/R01AG041676', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '54702', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Eau Claire Hospital, Inc.', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Franciscan Medical Center', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Lyle J Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Preventice', 'class': 'INDUSTRY'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Lyle J. Olson, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}