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Reducing Risk of Recurrence (RRR)

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ClinicalTrials.gov Identifier: NCT01122394
Recruitment Status : Completed
First Posted : May 13, 2010
Results First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke TIA Hypertension Hyperlipidemia Behavioral: TI Behavioral: AP Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)
Study Start Date : January 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tailored Intervention (TI)
Tailored intervention based on the transtheoretical model
 Behavioral: TI
Tailored intervention based on the transtheoretical model
Placebo Comparator: Attention Placebo (AP)
Attention Placebo
 Behavioral: AP
Attention placebo


Outcome Measures
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Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Dietary Sodium [ Time Frame: 6 months ]
    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)

  2. Total Cholesterol/High Density Lipoprotein Ratio [ Time Frame: 6 months ]
  3. Exercise Adherence [ Time Frame: 6 months ]
    Measured by 7-day Physical Activity Recall

  4. Antihypertensive/ Lipid-lowering Medication Adherence [ Time Frame: 6 months ]
    Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122394


Locations
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United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jennifer P Friedberg, PhD Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01122394    
Other Study ID Numbers: CDP 09-414
First Posted: May 13, 2010    Key Record Dates
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016
Last Verified: August 2016
Keywords provided by VA Office of Research and Development:
stroke
recurrence
blood pressure
prevention
Additional relevant MeSH terms:
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Stroke
Hyperlipidemias
Recurrence
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases