Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:04 PM
Study NCT ID:
NCT01875094
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Management in Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of blood pressure control into guideline recommended ranges', 'timeFrame': '3 months', 'description': 'The American Heart Association/American Stroke Association (AHA/ASA) have cited the JNC-7 in their guidelines to define normal blood pressure as \\< 120/80. We will use these guidelines and examine rates (percentage of subjects) of blood pressure control in intervention vs. usual care group.'}], 'secondaryOutcomes': [{'measure': 'Medication Compliance', 'timeFrame': '3 months', 'description': 'Percent of subjects who have discontinued one or more of the blood pressure medications on their own (i.e. without medical direction) in the intervention vs. usual care group.'}, {'measure': 'Use of online tool', 'timeFrame': '3 months', 'description': 'Ease of online health management tool use will be operationalized as the percent of subjects in the intervention group who measure their BP and enter it online at least 75% of the study period, 50% of the study period and those with 25% or less of the study period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '29763657', 'type': 'DERIVED', 'citation': 'Lakshminarayan K, Westberg S, Northuis C, Fuller CC, Ikramuddin F, Ezzeddine M, Scherber J, Speedie S. A mHealth-based care model for improving hypertension control in stroke survivors: Pilot RCT. Contemp Clin Trials. 2018 Jul;70:24-34. doi: 10.1016/j.cct.2018.05.005. Epub 2018 May 12.'}]}, 'descriptionModule': {'briefSummary': 'This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Stroke Survivors and their caregivers\n* English speaking\n* History of hypertension\n\nExclusion Criteria:\n\n-Cannot use the health-IT system'}, 'identificationModule': {'nctId': 'NCT01875094', 'briefTitle': 'Self-Management in Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Promoting Self-Management in Stroke Survivors Using Health IT', 'orgStudyIdInfo': {'id': '1212M25581'}, 'secondaryIdInfos': [{'id': 'R21HS021794', 'link': 'https://reporter.nih.gov/quickSearch/R21HS021794', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Management / MTM via Health IT', 'description': 'Stroke survivors are trained to measure and enter BP into an online health management tool', 'interventionNames': ['Other: Self-Management / MTM using Health IT']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Self-Management / MTM using Health IT', 'type': 'OTHER', 'armGroupLabels': ['Self-Management / MTM via Health IT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University_of_Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Berman Center for Outcomes and Clinical Research', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}