StrokePREVENTSNCT01020851
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
A study testing tailored intervention in people with Stroke and Transient Ischemic Attack, run by Narrows Institute for Biomedical Research at 1 site in United States.
Trial summary
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Well-documented history of stroke or TIA
- Age 21 years or older
- Continuity of care in the primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year
- On hypertensive and/or lipid-lowering agents
- A score of >16 on the Mini-Mental Status Exam-
- Ability to exercise (assessed by time to get up and go).
Who cannot join
- Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer
- No telephone number at which patient can be reached
- Plans to relocate within the next 6 months
- Inability to communicate over the telephone due to severe cognitive impairment or aphasia
Trial locations and contacts
1 site in 1 country.
United States1 site
VA New York Harbor Healthcare System, NY and Brooklyn Campuses
New York, New York, 10010
About this study
Official title: The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. By a randomized controlled trial, the investigators will test whether a tailored, telephone-delivered transtheoretical model-based behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo.
The primary specific aims of this project are to:
Read more
- determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA
- assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA.
Secondary aims are to
- assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months
- evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA
- determine whether the TI is effective in improving adherence to exercise recommendations after 6 months.
To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- tailored intervention, attention placebo
- Keywords
- hypertension, stroke, cholesterol, adherence
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored interventionBehavioural
Also called stage-matched intervention, transtheoretical model
6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
attention placeboBehavioural
6 monthly telephone-delivered sessions focusing on general health topics
| Study group | Role | What they receive |
|---|---|---|
| tailored intervention | Experimental | Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model. Receives: Behavioral: tailored intervention |
| attention placebo | Active comparator | Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics Receives: Behavioral: attention placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: 6 months
Secondary outcomes (4)
cholesterol
Measured: 6 months
dietary adherence
Measured: 6 months
exercise adherence
Measured: 6 months
medication adherence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Narrows Institute for Biomedical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Friedberg, Narrows Institute for Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020851
- Sponsor's protocol ID
- AHA0835195N
- Acronym
- PREVENTS
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
- ClinicalTrials.gov ID
- NCT01020851
- Acronym / sponsor ID
- PREVENTS / AHA0835195N
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- hypertension, stroke, cholesterol, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Narrows Institute for Biomedical ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Nov 2009 (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.
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. By a randomized controlled trial, the investigators will test whether a tailored, telephone-delivered transtheoretical model-based behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo.
The primary specific aims of this project are to:
- determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA
- assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA.
Secondary aims are to
- assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months
- evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA
- determine whether the TI is effective in improving adherence to exercise recommendations after 6 months.
To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tailored intervention | Experimental | Behavioral: tailored interventionParticipants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model. |
| attention placebo | Active comparator | Behavioral: attention placeboParticipants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Well-documented history of stroke or TIA
- Age 21 years or older
- Continuity of care in the primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year
- On hypertensive and/or lipid-lowering agents
- A score of >16 on the Mini-Mental Status Exam-
Key exclusion criteria (4 listed)
- Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer
- No telephone number at which patient can be reached
- Plans to relocate within the next 6 months
- Inability to communicate over the telephone due to severe cognitive impairment or aphasia
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 |
|---|---|---|
| tailored interventionAlso: stage-matched intervention, transtheoretical model6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model | Behavioural | tailored intervention |
| attention placebo6 monthly telephone-delivered sessions focusing on general health topics | Behavioural | attention placebo |
Primary outcome
blood pressure
Time frame: 6 months
4 secondary outcomes
cholesterol
Time frame: 6 months
dietary adherence
Time frame: 6 months
exercise adherence
Time frame: 6 months
medication adherence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored intervention in people with Stroke and Transient Ischemic Attack, run by Narrows Institute for Biomedical Research at 1 site in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2015.