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Reducing Risk of Recurrence (RRR)

Primary Purpose

Stroke, TIA, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TI
AP
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, recurrence, blood pressure, prevention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tailored Intervention (TI)

Attention Placebo (AP)

Arm Description

Tailored intervention based on the transtheoretical model

Attention Placebo

Outcomes

Primary Outcome Measures

Systolic Blood Pressure

Secondary Outcome Measures

Dietary Sodium
self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)
Total Cholesterol/High Density Lipoprotein Ratio
Exercise Adherence
Measured by 7-day Physical Activity Recall
Antihypertensive/ Lipid-lowering Medication Adherence
Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent

Full Information

First Posted
May 10, 2010
Last Updated
August 26, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01122394
Brief Title
Reducing Risk of Recurrence
Acronym
RRR
Official Title
Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, TIA, Hypertension, Hyperlipidemia
Keywords
stroke, recurrence, blood pressure, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Intervention (TI)
Arm Type
Experimental
Arm Description
Tailored intervention based on the transtheoretical model
Arm Title
Attention Placebo (AP)
Arm Type
Placebo Comparator
Arm Description
Attention Placebo
Intervention Type
Behavioral
Intervention Name(s)
TI
Intervention Description
Tailored intervention based on the transtheoretical model
Intervention Type
Behavioral
Intervention Name(s)
AP
Intervention Description
Attention placebo
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dietary Sodium
Description
self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)
Time Frame
6 months
Title
Total Cholesterol/High Density Lipoprotein Ratio
Time Frame
6 months
Title
Exercise Adherence
Description
Measured by 7-day Physical Activity Recall
Time Frame
6 months
Title
Antihypertensive/ Lipid-lowering Medication Adherence
Description
Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer P Friedberg, PhD
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

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Reducing Risk of Recurrence

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