Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00798551
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2008-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emergency Department Interventions to Improve Blood Pressure Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular 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': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2010-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follow-up with Primary care physician', 'timeFrame': 'one month', 'description': 'The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '12658251', 'type': 'RESULT', 'citation': 'Backer HD, Decker L, Ackerson L. Reproducibility of increased blood pressure during an emergency department or urgent care visit. Ann Emerg Med. 2003 Apr;41(4):507-12. doi: 10.1067/mem.2003.151.'}, {'pmid': '16141017', 'type': 'RESULT', 'citation': 'Karras DJ, Ufberg JW, Heilpern KL, Cienki JJ, Chiang WK, Wald MM, Harrigan RA, Wald DA, Shayne P, Gaughan J, Kruus LK. Elevated blood pressure in urban emergency department patients. Acad Emerg Med. 2005 Sep;12(9):835-43. doi: 10.1197/j.aem.2005.04.015.'}, {'pmid': '10333343', 'type': 'RESULT', 'citation': 'Preston RA, Baltodano NM, Cienki J, Materson BJ. Clinical presentation and management of patients with uncontrolled, severe hypertension: results from a public teaching hospital. J Hum Hypertens. 1999 Apr;13(4):249-55. doi: 10.1038/sj.jhh.1000796.'}]}, 'descriptionModule': {'briefSummary': 'Hypertension affects approximately 65 million people in the United States and approximately 20 million individuals remain undiagnosed. In Emergency Room visits, many as one third of the patients were noted to have elevated BP readings, two thirds of which could benefit from further therapy or closer clinic follow-up. However primary care follow-up after discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the Emergency Room visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.', 'detailedDescription': 'Hypertension is a very common disease, affecting approximately 65 million people in the United States. As many as 30 % of people with hypertension, approximately 20 million individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to have elevated BP readings in prior studies. Approximately 5% of emergency department (ED) patients have severely elevated blood pressure. Prior studies suggest that as many as two thirds of ED patients with elevated BP can benefit from further therapy or closer clinic follow-up. However primary care follow-up after ED discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age or older\n* diastolic BP 90 mm Hg or systolic BP 140 mm Hg\n* diabetes and chronic kidney disease who have a diastolic BP 80 mm Hg or systolic BP 130 mm Hg\n\nExclusion Criteria:\n\n* unable/unwilling to provide informed consent\n* acute anxiety state\n* Any subject on pain medication which compromises their ability to consent'}, 'identificationModule': {'nctId': 'NCT00798551', 'briefTitle': 'Emergency Department Interventions to Improve Blood Pressure Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Emergency Department Interventions to Improve Blood Pressure Follow-up', 'orgStudyIdInfo': {'id': '0519-07-EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Risk counseling', 'description': 'Risk counseling regarding elevated blood pressure', 'interventionNames': ['Behavioral: Risk counseling']}], 'interventions': [{'name': 'Risk counseling', 'type': 'BEHAVIORAL', 'description': 'cardiovascular risk counseling regarding elevated blood pressure', 'armGroupLabels': ['Risk counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Srikar R Adhikari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}