Reducing Risk of Recurrence (RRR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01122394
First received: May 10, 2010
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Stroke
TIA
Hypertension
Hyperlipidemia
Behavioral: TI
Behavioral: AP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dietary sodium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • total cholesterol/high density lipoprotein ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • exercise adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • antihypertensive/ lipid-lowering medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 202
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Tailored intervention based on the transtheoretical model
Behavioral: TI
Tailored intervention based on the transtheoretical model
Placebo Comparator: Arm 2
Attention Placebo
Behavioral: AP
Attention placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122394

Contacts
Contact: Julia Levine, MPA (212) 951-3395 julia.levine@va.gov

Locations
United States, New York
New York Harbor HCS Recruiting
New York, New York, United States, 10010
Contact: Julia Levine, MPA    212-951-3395    julia.levine@va.gov   
Principal Investigator: Jennifer P Friedberg, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jennifer P Friedberg, PhD New York Harbor HCS
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01122394     History of Changes
Other Study ID Numbers: CDP 09-414
Study First Received: May 10, 2010
Last Updated: April 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
stroke
recurrence
blood pressure
prevention

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Recurrence
Stroke
Cerebral Infarction
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014