Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
Study NCT ID:
NCT03782857
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2018-12-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention After Stroke - a Nurse-led Physician-supervised Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized 1:1 to intervention or control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduction in LDL-cholesterol', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up'}, {'measure': 'LDL-cholesterol treated to target', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'In non-diabetic participants with ischemic stroke the target of lipid lowering treatment was LDL\\<2.5 mmol/l and \\<2.0 mmol/l in case of diabetes'}, {'measure': 'Intensification of preventive treatment', 'timeFrame': 'From discharge from the stroke unit to final follow up in study', 'description': 'Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge'}, {'measure': 'Adherence with preventive medication', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'Proportion of participants with at least 80% adherence with preventive medication'}, {'measure': 'Healthy lifestyle', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'Proportion of participants on a healthy diet, moderate physical activity for four hours/week, smoking cessation in baseline daily smokers, reduction of an overuse of alcohol to recommended level'}, {'measure': 'Time to cardiovascular complications', 'timeFrame': 'From inclusion in the study to a median of 65 (61-66) months after inclusion', 'description': 'Time to recurrent stroke, myocardial infarction and death in months'}], 'primaryOutcomes': [{'measure': 'Blood pressure treated to target', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'The investigator used individual targets of blood pressure: In case of hemorrhagic stroke: BP\\<130/80 mm Hg, in case of ischemic heart disease: BP target according to stroke diagnosis, but no lower than 130/80 mm Hg, in case of diabetes or chronic kidney disease: BP\\<130/80 mm Hg, age\\>80 years: \\<150/90 mm Hg, others: \\<140/90 mm Hg'}], 'secondaryOutcomes': [{'measure': 'Reduction in blood pressure', 'timeFrame': 'At follow up 10 months after inclusion in the study', 'description': 'Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The study evaluates the effect of early follow up in a preventive clinic with stepwise treatment of high blood pressure and lowering blood cholesterol. Half the participants were randomized to the preventive clinic group and the other half to control group with the usual treatment: one visit to the outpatient clinic three months after discharge with a diagnosis of stroke or transient ischemic attack (TIA)', 'detailedDescription': "Hypertension is the most important modifiable risk factor for recurrent stroke. Several studies have shown that less than 40% of stroke survivors are treated to target one year after stroke The investigator performed a feasibility study to test a model of treating this important risk factor in a hospital setting The investigator used a stepwise escalation of treatment of both blood pressure and blood cholesterol to individual targets according to patients' diagnosis of stroke, comorbidity and age"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients diagnosed with a stroke during stay in the stroke unit of Herlev Hospital\n\nExclusion Criteria: Severe stroke giving a modified Rankin Scale score \\>4, severe cognitive deficits or dementia, discharge to a nursing home'}, 'identificationModule': {'nctId': 'NCT03782857', 'briefTitle': 'Prevention After Stroke - a Nurse-led Physician-supervised Model', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Prevention After Stroke - a Nurse-led Physician-Supervised Model. A Feasibility Study', 'orgStudyIdInfo': {'id': '2012-41-0429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Initiation/stepwise escalation of antihypertensive medication in case of blood pressure above individual target Initiation/stepwise escalation of cholesterol lowering medication in case of LDL-cholesterol above individual target Advice on healthy lifestyle and life long adherence to preventive medication', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants had the usual treatment: all patients were invited to one visit in the outpatient clinic three months after discharge with a diagnosis of stroke/TIA'}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nete Hornnes, MPH,Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nete Hornnes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Nurse', 'investigatorFullName': 'Nete Hornnes', 'investigatorAffiliation': 'Herlev Hospital'}}}}