Stroke
Conditions
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
Interventions
BEHAVIORALIntervention
Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment
Sponsors
Nete Hornnes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants were randomized 1:1 to intervention or control group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure treated to target | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction in blood pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Intensification of preventive treatment | 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 |
| Adherence with preventive medication | At follow up 10 months after inclusion in the study | Proportion of participants with at least 80% adherence with preventive medication |
| Reduction in LDL-cholesterol | 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 |
| Time to cardiovascular complications | 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 |
| Healthy lifestyle | 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 |
| LDL-cholesterol treated to target | 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 |
Outcome results
None listed