The Post Stroke Preventive Trial (PREVENT). A RCT Nested in a Cohort Study

NCT ID: NCT00253097

Last Updated: 2009-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-10-31

Brief Summary

Patients with a diagnosis of stroke or TIA, who are already included in the RIALTO-cohort study are asked to participate in a RCT after discharge from hospital.

Patients in the intervention group will receive four visits by a study nurse with the aim of controlling the patient's hypertension, reducing risk factors like tobacco smoking and obesity, and motivating the patient to physical activity and to a healthy diet.Patients in the control group will receive the usual treatment.

This study is aimed at testing the hypothesis, that

Primary outcome: the blood pressure lowering will be greater in the intervention group Secondary outcomes: the blood pressure will be lower in the intervention group and the number of patients who have stopped smoking will be greater in the intervention group The number of obese patients who have reduced their BMI will be greater in the intervention group The number of patients with a Rankin Scale<3 who are physically active for four hours a week will be greater in the intervention group Time to recurrent stroke, MI and death will be longer in the intervention group

Outcomes are measured by follow up visit one and two years after inclusion in the study

Expected Total Enrollment: 342 in the RCT, 1200 in the cohort

Study Start: 011205 (PREVENT) Study Completion: January 2009(PREVENT), September 2013 (RIALTO Cohort study)

Detailed Description

Stroke survivors are at risk of cerebrovascular and cardiovascular complications. In Denmark 25% of stroke admissions are caused by recurrent stroke or TIA. Little is known of the risk factors for recurrent stroke. This is being investigated in a cohort study (RIALTO) initiated in may 2004. The PREVENT study is aimed at studying the health behavior of stroke survivors as well as the effect of a preventive intervention aimed at risk factors associated with hypertension. Hypertension is the main risk factor for primary stroke and the one risk factor known to be associated with stroke recurrence.

Inclusion criteria: inclusion in the RIALTO-cohort, no severe cognitive deficits or dementia, no other life threatening disease.

Exclusion criteria: discharge to a nursing home

Participants (n=342) are randomised to either the intervention group (n=171) or the control group (n=171). Randomisation is performed by a computer-generated allocation schedule, with the randomisation sequence blocked from previewing. The analyser will be blinded from the allocation of the patients.

Baselinedata: Blood pressure, BMI and Rankin scale will be monitored few days prior to discharge.Blood pressure will be measured according to standards set by the Danish Society of hypertension.

Patients in the intervention group will receive a visit by a study nurse one, four, seven, and ten months after discharge. The aim of the visits are: controlling the patient's hypertension, reducing risk factors like tobacco smoking and obesity, motivating the patient to physical activity and to a healthy diet as well as compliance with pharmacological treatment of hypertension, diabetes, hypercholesterolemia and anti-thrombotic treatment.Patients in the control group will receive the usual treatment.

This study is aimed at testing the hypothesis, that

Primary outcome: the blood pressure lowering will be greater in the intervention group Secondary outcomes: the blood pressure will be lower in the intervention group and the number of patients who have stopped smoking will be greater in the intervention group The number of obese patients who have reduced their BMI will be greater in the intervention group The number of patients with a Rankin Scale<3 who are physically active for four hours a week will be greater in the intervention group Time to recurrent stroke, MI and death will be longer in the intervention group

Outcomes are measured by follow up visit one and two years after inclusion in the study. Hypertension is defined as a blood pressure > 140 mm Hg or > 90 mm Hg. The diagnosis of a recurrent stroke will be based on a CT og MR scan or on the clinical diagnosis made by a neurologist.MI should be confirmed by an ECG and by relevant biomarkers.

All participants will be followed up by register data for six years from inclusion as will all participants of the RIALTO cohort.

Conditions

Cerebrovascular Accident; Transient Ischemic Attack; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Patients in the control group had the usual care provided at the stroke unit, that is counselling on avoiding risky health behavior, compliance with preventive medication, measurement of blood pressure and a 3 months' visit in the outpatient clinic

Group Type: NO_INTERVENTION

Intervention

Intervention Type: BEHAVIORAL

Patients allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate

Intervention

Patienta allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

Patients allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate

Interventions

Intervention

Patients allocated to the intervention group have 4 visits by a study nurse. She will measure patient's blood pressure (BP) by standardized meathods, inform the patient about the target BP, stress the importance of lowering the BP and in case of elevated BP she advices the patient to go the the GP for further control. She advises about smoking cessation, reduction of alcohol consumption, loss of excess body weigt and stresses the importance of physical activity as appropriate

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• a diagnosis of stroke or TIA inclusion in the RIALTO cohort no severe cognitive deficits or dementia

Exclusion Criteria

• discharge to a nursing home

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Copenhagen University Hospital, Hvidovre

Principal Investigators

Nete Hornnes, RN, MPH

Role: STUDY_DIRECTOR

Clinical Research Unit, Hvidovre Hospital

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Frederiksb Hospital

Frederiksberg, , Denmark

Countries

Denmark

References

Hornnes N, Larsen K, Brink-Kjaer T, Boysen G. Specific antismoking advice after stroke. Dan Med J. 2014 Apr;61(4):A4816.

Reference Type: DERIVED

PMID: 24814592 (View on PubMed)

Other Identifiers

KFE 003

Identifier Type: -

Identifier Source: org_study_id