Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01122394
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2010-05-10
Brief Title:
Reducing Risk of Recurrence
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Reducing Risk of Recurrences Issues in Maintenance and Stability in Stroke CDA 08-009
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RRR
Brief Summary:
Adults who have had a previous stroke or transient ischemic attack TIA remain at risk for having a second serious event especially if they have uncontrolled blood pressure or cholesterol However many patients have difficulty following treatment recommendations for lowering blood pressure and cholesterol The purpose of this research project is to evaluate the effect of 2 booster sessions of an educational counseling intervention on how well adults who have already participated in a 6-month clinical trial had a stroke or transient ischemic attack TIA are able to follow a treatment plan and control their blood pressure and cholesterol levels We will also examine how effective this intervention is in improving adherence to diet medication and physical activity recommendations for adults who have had a prior stroke or TIA
Detailed Description:
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 We will determine whether a telephone-delivered behaviorally tailored intervention TI can lead to sustained change resulting in a BP and lipid control and b improved adherence to diet medication and exercise recommendations in veterans with a history of stroke or TIA compared to an attention placebo AP in veterans who have completed 6 months of a clinical trial In this CDA project we evaluate the long-term effectiveness of booster sessions in a randomized manner One arm will receive 6 months of a tailored intervention TI followed by two booster TI sessions at 8 and 10 months and one arm will receive 6 months of an attention placebo AP followed by two booster AP sessions at 8 and 10 months BP 3 measures taken at least 5 min apart and dietary sodium are the primary outcomes while secondary outcomes will be total cholesterolhigh density lipoprotein ratio adherence to antihypertensive and lipid-lowering drugs and exercise adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None