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Prevention After Stroke - a Nurse-led Physician-supervised Model

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention
Sponsored by
Nete Hornnes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with a stroke during stay in the stroke unit of Herlev Hospital

Exclusion Criteria: Severe stroke giving a modified Rankin Scale score >4, severe cognitive deficits or dementia, discharge to a nursing home

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Blood pressure treated to target
    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

    Secondary Outcome Measures

    Reduction in blood pressure
    Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up

    Full Information

    First Posted
    December 19, 2018
    Last Updated
    December 20, 2018
    Sponsor
    Nete Hornnes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03782857
    Brief Title
    Prevention After Stroke - a Nurse-led Physician-supervised Model
    Official Title
    Prevention After Stroke - a Nurse-led Physician-Supervised Model. A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 26, 2012 (Actual)
    Primary Completion Date
    December 17, 2013 (Actual)
    Study Completion Date
    December 17, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nete Hornnes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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)
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomized 1:1 to intervention or control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention
    Intervention Description
    Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment
    Primary Outcome Measure Information:
    Title
    Blood pressure treated to target
    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
    Time Frame
    At follow up 10 months after inclusion in the study
    Secondary Outcome Measure Information:
    Title
    Reduction in blood pressure
    Description
    Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up
    Time Frame
    At follow up 10 months after inclusion in the study
    Other Pre-specified Outcome Measures:
    Title
    Reduction in LDL-cholesterol
    Description
    Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up
    Time Frame
    At follow up 10 months after inclusion in the study
    Title
    LDL-cholesterol treated to target
    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
    Time Frame
    At follow up 10 months after inclusion in the study
    Title
    Intensification of preventive treatment
    Description
    Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge
    Time Frame
    From discharge from the stroke unit to final follow up in study
    Title
    Adherence with preventive medication
    Description
    Proportion of participants with at least 80% adherence with preventive medication
    Time Frame
    At follow up 10 months after inclusion in the study
    Title
    Healthy lifestyle
    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
    Time Frame
    At follow up 10 months after inclusion in the study
    Title
    Time to cardiovascular complications
    Description
    Time to recurrent stroke, myocardial infarction and death in months
    Time Frame
    From inclusion in the study to a median of 65 (61-66) months after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with a stroke during stay in the stroke unit of Herlev Hospital Exclusion Criteria: Severe stroke giving a modified Rankin Scale score >4, severe cognitive deficits or dementia, discharge to a nursing home
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nete Hornnes, MPH,Ph.d
    Organizational Affiliation
    Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prevention After Stroke - a Nurse-led Physician-supervised Model

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