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

NCT03782857 | Completed DMC

• 1 other identifier: 2012-41-0429
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in blood pressure

  At follow up 10 months after inclusion in the study

Other Outcomes (6)

• Reduction in LDL-cholesterol

  At follow up 10 months after inclusion in the study

• LDL-cholesterol treated to target

  At follow up 10 months after inclusion in the study

• Intensification of preventive treatment

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Intervention BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Nete Hornnes: lead

MeSH Terms

Conditions

Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Nete Hornnes, MPH,Ph.d

  Department of Neurology, Herlev Hospital, 2730 Herlev, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Nurse

Model Details: Participants were randomized 1:1 to intervention or control group

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: June 26, 2012
• Primary Completion: December 17, 2013
• Study Completion: December 17, 2013
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share