Cerebrovascular AccidentPREVENTNCT00253097
The Post Stroke Preventive Trial (PREVENT). A RCT Nested in a Cohort Study
A study testing Intervention in people with Cerebrovascular Accident and Transient Ischemic Attack, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cerebrovascular Accident, Transient Ischemic Attack, Myocardial Infarction
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 2 sitesDenmark
- Study dates
- Dec 2005to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of stroke or TIA inclusion in the RIALTO cohort no severe cognitive deficits or dementia
Who cannot join
- discharge to a nursing home
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Copenhagen, 2400
Frederiksb Hospital
Frederiksberg, 2000
About this study
Official title: The Post Stroke Preventive Trial (PREVENT) A Randomised Controlled Trial Nested in a Cohort (RIALTO) Study
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.
Read more
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)
Read the 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.
- Being tested
- Intervention
- Keywords
- stroke recurrence, risk factors, health behavior, intervention, tertiary prevention
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Myocardial Infarction, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 Receives: Behavioral: Intervention |
| Intervention | Experimental | 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 Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure lowering at 12 and 24 months
Measured: November 2006 - october 2009
Secondary outcomes (6)
blood pressure
Measured: November 2006 - october 2009
BMI
Measured: November 2006 - october 2009
Level of physical activity
Measured: November 2006 - october 2009
Time to events:Stroke recurrence, MI and death
Measured: November 2006 - october 2009
all assessed 12 and 24 months after inclusion in the study
Measured: November 2006 - october 2009
Smoking cessation
Measured: november 2006 to october 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nete Hornnes, RN, MPH, Study director, Clinical Research Unit, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253097
- Sponsor's protocol ID
- KFE 003
- Acronym
- PREVENT
- Status last verified
- Jul 2009
- First submitted
- 14 Nov 2005
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hornnes N, Larsen K, Brink-Kjaer T, Boysen G. Specific antismoking advice after stroke. Dan Med J. 2014 Apr;61(4):A4816.
PubMed 24814592
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Post Stroke Preventive Trial (PREVENT) A Randomised Controlled Trial Nested in a Cohort (RIALTO) Study
- ClinicalTrials.gov ID
- NCT00253097
- Acronym / sponsor ID
- PREVENT / KFE 003
- Keywords
- stroke recurrence, risk factors, health behavior, intervention, tertiary prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Behavioral: 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 | Experimental | Behavioral: InterventionPatienta 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of stroke or TIA inclusion in the RIALTO cohort no severe cognitive deficits or dementia
Key exclusion criteria (1 listed)
- discharge to a nursing home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionPatients 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 | Behavioural | Control, Intervention |
Primary outcome
blood pressure lowering at 12 and 24 months
Time frame: November 2006 - october 2009
6 secondary outcomes
blood pressure
Time frame: November 2006 - october 2009
BMI
Time frame: November 2006 - october 2009
Level of physical activity
Time frame: November 2006 - october 2009
Time to events:Stroke recurrence, MI and death
Time frame: November 2006 - october 2009
all assessed 12 and 24 months after inclusion in the study
Time frame: November 2006 - october 2009
Smoking cessation
Time frame: november 2006 to october 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
- Derived from this study: PubMed 24814592Hornnes N, Larsen K, Brink-Kjaer T, Boysen G. Specific antismoking advice after stroke. Dan Med J. 2014 Apr;61(4):A4816.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nete Hornnes, RN, MPH study director
Clinical Research Unit, Hvidovre Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cerebrovascular Accident and Transient Ischemic Attack, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure lowering at 12 and 24 months (time frame: November 2006 - october 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.