Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 3:29 PM
Study NCT ID:
NCT01362751
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthostatic Hypotension in Elderly Nursing Home Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007024', 'term': 'Hypotension, Orthostatic'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-02', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2011-05-27', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orthostatic hypotension', 'timeFrame': 'Baseline', 'description': 'Orthostatic hypotension is defined by consensus as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes in the upright position'}, {'measure': 'Successful rehabilitation', 'timeFrame': 'After 5 years', 'description': 'Successful rehabilitation is defined as whether the patient is able to return to his/her home or another location (but not a nursing home) after discharge from the nursing home. Unsuccessful rehabilitations implies that the patients becomes a long-stay nursing home resident.'}], 'secondaryOutcomes': [{'measure': 'All-cause and Cardiovascular mortality', 'timeFrame': 'Date of death'}, {'measure': 'Quality of life', 'timeFrame': 'Measured at baseline and after 1 year', 'description': 'Quality of life is measured using the RAND-36 questionnaire.'}, {'measure': 'Fall incidents', 'timeFrame': 'After 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orthostatic Hypotension']}, 'referencesModule': {'references': [{'pmid': '26026216', 'type': 'DERIVED', 'citation': 'Hartog LC, Cizmar-Sweelssen M, Knipscheer A, Groenier KH, Kleefstra N, Bilo HJ, van Hateren KJ. The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):190-6. doi: 10.1016/j.archger.2015.05.005. Epub 2015 May 18.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators aimed\n\n1. to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.\n2. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nursing home residents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nursing home resident\n\nExclusion Criteria:\n\n* patients at the palliative department\n* life expectancy \\< 4 weeks\n* patients only temporarily admitted to the nursing home'}, 'identificationModule': {'nctId': 'NCT01362751', 'briefTitle': 'Orthostatic Hypotension in Elderly Nursing Home Residents', 'organization': {'class': 'OTHER', 'fullName': 'Medical Research Foundation, The Netherlands'}, 'orgStudyIdInfo': {'id': 'OH_TMZ_2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nursing home residents', 'description': "In this study, patients from both the somatic and the psychogeriatric department are included. For the primary endpoint 'successful rehabilitation' only the patients from the somatic departments are included.", 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This study is an observational cohort study \\> no interventions', 'armGroupLabels': ['Nursing home residents']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hengelo', 'country': 'Netherlands', 'facility': 'Nursing home TriviumMeulenbeltZorg, location Borsthuis', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Foundation, The Netherlands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kornelis J.J. van Hateren', 'investigatorAffiliation': 'Medical Research Foundation, The Netherlands'}}}}