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

Study Overview
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Brief Summary
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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
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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

Official Title
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Prevention After Stroke - a Nurse-led Physician-Supervised Model. A Feasibility Study

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized 1:1 to intervention or control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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 | Behavioral: Intervention<br>* Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment<br>|
| No Intervention: Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At follow up 10 months after inclusion in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood pressure | Difference between blood pressure at inclusion in the study and blood pressure measured at final follow up | At follow up 10 months after inclusion in the study |