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

Purpose

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)

Condition	Intervention
Cerebrovascular Accident Transient Ischemic Attack Myocardial Infarction	Behavioral: Intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Post Stroke Preventive Trial (PREVENT) A Randomised Controlled Trial Nested in a Cohort (RIALTO) Study

Resource links provided by NLM:

MedlinePlus related topics: Healthy Living Heart Attack Quitting Smoking Smoking Smoking and Youth Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

blood pressure lowering at 12 and 24 months [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood pressure [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]
BMI [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]
Level of physical activity [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]
Time to events:Stroke recurrence, MI and death [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]
all assessed 12 and 24 months after inclusion in the study [ Time Frame: November 2006 - october 2009 ] [ Designated as safety issue: No ]
Smoking cessation [ Time Frame: november 2006 to october 2009 ] [ Designated as safety issue: No ]

Enrollment:	353
Study Start Date:	December 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 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	Behavioral: 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
Experimental: 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	Behavioral: 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

Arms

Assigned Interventions

No Intervention: 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

Behavioral: 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

Experimental: 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

Behavioral: 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

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253097

Locations

Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Frederiksb Hospital
Frederiksberg, Denmark, 2000

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Study Director:

Nete Hornnes, RN, MPH

Clinical Research Unit, Hvidovre Hospital

More Information

No publications provided

Responsible Party:	Nete Hornnes Research Director, Ph.d-student, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:	NCT00253097 History of Changes
Other Study ID Numbers:	KFE 003
Study First Received:	November 14, 2005
Last Updated:	August 10, 2009
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:

stroke recurrence
risk factors
health behavior
intervention
tertiary prevention

Additional relevant MeSH terms:

Ischemic Attack, Transient
Infarction
Myocardial Infarction
Cerebral Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 22, 2013