Reducing Risk of Recurrence

Stroke Clinical Trial

— RRR  

Official title:

Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122394
• Other study ID #: CDP 09-414
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: August 25, 2015
• Start date: January 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment;

• Age 21 years or older;

• Continuity of care in the VAMC 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 6-minute walk or timed get up and go).

Exclusion Criteria:

• 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 outside of the NYC area within the next 6 months;

• Inability to communicate over the telephone due to severe cognitive impairment or aphasia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Recurrence
• Stroke
• TIA

Intervention

Behavioral:
• TI
Tailored intervention based on the transtheoretical model
• AP
Attention placebo

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		6 months	No
Secondary	dietary sodium		6 months	No
Secondary	total cholesterol/high density lipoprotein ratio		6 months	No
Secondary	exercise adherence		6 months	No
Secondary	antihypertensive/ lipid-lowering medication adherence		6 months	No