Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-26 @ 8:47 PM
Study NCT ID:
NCT04212468
Status:
RECRUITING
Last Update Posted:
2020-01-13
First Post:
2019-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Blood Pressure Monitoring Registration Study in the Elderly(HOME Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'This study will collect 20 mL whole blood samples from subjects at one or more study visits. The whole blood will be processed to plasma and stored for testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2019-12-24', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with reported hospitalization due to other diseases', 'timeFrame': 'From date of inclusion until the date of first event, assessed up to 1 year', 'description': 'The incidence rate of tumor, fracture, cataract etc.'}], 'primaryOutcomes': [{'measure': 'All-Cause Mortality', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year', 'description': 'All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention.'}, {'measure': 'Cardiovascular Mortality', 'timeFrame': 'From date of inclusion until the date of death from any cause, assessed up to 1 year', 'description': 'Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke).'}], 'secondaryOutcomes': [{'measure': 'Secondary outcomes of cardiovascular diseases', 'timeFrame': 'Through study completion, an average of 1 years', 'description': 'The number of and the incidence rate of cardiovascular diseases.'}, {'measure': 'Secondary outcomes of cerebrovascular diseases', 'timeFrame': 'Through study completion, an average of 1 years', 'description': 'The incidence rate of cerebrovascular diseases.'}, {'measure': 'Secondary outcomes of kidney', 'timeFrame': 'Through study completion, an average of 1 years', 'description': 'The incidence rate of renal injure and end-stage renal disease'}, {'measure': 'Secondary outcomes of hypertension', 'timeFrame': 'Through study completion, an average of 1 years', 'description': 'The incidence rate of hypertension'}, {'measure': 'Secondary outcomes of diabetes', 'timeFrame': 'Through study completion, an average of 1 years', 'description': 'The incidence rate of diabetes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure', 'Elderly'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'China is entering an aging society. As the number of elderly population continues to increase, the elderly are facing many social problems that deserve the attention of all sectors of society. Hypertension is one of the common diseases in the elderly population. Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. Home blood pressure monitoring is simple, not only can find hypertension, but also can guide the treatment of patients with hypertension. The purpose of the study is to investigate the association between home blood pressure and adverse outcomes in community elderly population.', 'detailedDescription': 'Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age, and have provided written informed consent to provide home blood pressure monitoring at one or more study visits.\n\nPhysical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population includes subjects who living in community, of any race or ethnicity, 65 or older years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•≥65 years old\n\n* Signed informed consent\n* Life expectancy is greater than 1 year\n\nExclusion Criteria:\n\n* \\<65 years old\n* Unsigned informed consent'}, 'identificationModule': {'nctId': 'NCT04212468', 'briefTitle': 'Home Blood Pressure Monitoring Registration Study in the Elderly(HOME Study)', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Home Blood Pressure Registration Study on Community Elderly Population(HOME Study)', 'orgStudyIdInfo': {'id': '2018300H(R1)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Ying-qing, PhD', 'role': 'CONTACT', 'email': '651792209@qq.com', 'phone': '+862083827812'}], 'facility': 'Feng Yingqing', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'FENG Ying-qing', 'role': 'CONTACT', 'email': 'fyq1819@163.com', 'phone': '02083827812'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Feng Ying-qing, PhD', 'role': 'CONTACT', 'email': '651792209@qq.com', 'phone': '+862083827812'}], 'overallOfficials': [{'name': 'Feng Ying-qing, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}