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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782857
• Other study ID #: 2012-41-0429
• Status: Completed
• Phase: N/A
• Start date: June 26, 2012
• Est. completion date: December 17, 2013

Study information

• Verified date: December 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 17, 2013
• Est. primary completion date: December 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nete Hornnes

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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