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

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

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)

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Intervention

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment
No Intervention: Control group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in LDL-cholesterol	Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up	At follow up 10 months after inclusion in the study
LDL-cholesterol treated to target	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	At follow up 10 months after inclusion in the study
Intensification of preventive treatment	Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge	From discharge from the stroke unit to final follow up in study
Adherence with preventive medication	Proportion of participants with at least 80% adherence with preventive medication	At follow up 10 months after inclusion in the study
Healthy lifestyle	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	At follow up 10 months after inclusion in the study
Time to cardiovascular complications	Time to recurrent stroke, myocardial infarction and death in months	From inclusion in the study to a median of 65 (61-66) months after inclusion

Collaborators and Investigators

• Sponsor: Nete Hornnes
• Investigators: Principal Investigator: Nete Hornnes, MPH,Ph.d, Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2012
• Primary Completion (Actual): December 17, 2013
• Study Completion (Actual): December 17, 2013

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2012-41-0429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No