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Completed

NCT Number: NCT03782857

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

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)

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment

Primary outcomes

  1. Blood pressure treated to target

    Time frame: At follow up 10 months after inclusion in the study

    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 outcomes

  1. Reduction in blood pressure

    Time frame: At follow up 10 months after inclusion in the study

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

Other outcomes

  1. Reduction in LDL-cholesterol

    Time frame: At follow up 10 months after inclusion in the study

    Difference between LDL-cholesterol at inclusion in the study and LDL-cholesterol measured at final follow up

  2. LDL-cholesterol treated to target

    Time frame: At follow up 10 months after inclusion in the study

    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

  3. Intensification of preventive treatment

    Time frame: From discharge from the stroke unit to final follow up in study

    Proportion of participants who had an intensification of antihypertensive / lipid lowering medication since discharge

  4. Adherence with preventive medication

    Time frame: At follow up 10 months after inclusion in the study

    Proportion of participants with at least 80% adherence with preventive medication

  5. Healthy lifestyle

    Time frame: At follow up 10 months after inclusion in the study

    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

  6. Time to cardiovascular complications

    Time frame: From inclusion in the study to a median of 65 (61-66) months after inclusion

    Time to recurrent stroke, myocardial infarction and death in months

Sponsors and collaborators

Lead sponsor

Nete Hornnes

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2018
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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