The Post Stroke Preventive Trial (PREVENT). A RCT Nested in a Cohort Study
PREVENT
1 other identifier
interventional
353
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 11, 2009
July 1, 2009
3.8 years
November 14, 2005
August 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure lowering at 12 and 24 months
November 2006 - october 2009
Secondary Outcomes (6)
blood pressure
November 2006 - october 2009
BMI
November 2006 - october 2009
Level of physical activity
November 2006 - october 2009
Time to events:Stroke recurrence, MI and death
November 2006 - october 2009
all assessed 12 and 24 months after inclusion in the study
November 2006 - october 2009
- +1 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients 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
Intervention
EXPERIMENTALPatienta 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
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
Eligibility Criteria
You may not qualify if:
- discharge to a nursing home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Frederiksb Hospital
Frederiksberg, 2000, Denmark
Related Publications (1)
Hornnes N, Larsen K, Brink-Kjaer T, Boysen G. Specific antismoking advice after stroke. Dan Med J. 2014 Apr;61(4):A4816.
PMID: 24814592DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nete Hornnes, RN, MPH
Clinical Research Unit, Hvidovre Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 15, 2005
Study Start
December 1, 2005
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 11, 2009
Record last verified: 2009-07