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Reducing Risk of Recurrence (RRR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01122394
First received: May 10, 2010
Last updated: August 26, 2016
Last verified: August 2016

May 10, 2010
August 26, 2016
January 2010
June 2015   (final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01122394 on ClinicalTrials.gov Archive Site
  • Dietary Sodium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exercise Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by 7-day Physical Activity Recall
  • Antihypertensive/ Lipid-lowering Medication Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent
  • 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 ]
Not Provided
Not Provided
 
Reducing Risk of Recurrence
Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • TIA
  • Hypertension
  • Hyperlipidemia
  • Behavioral: TI
    Tailored intervention based on the transtheoretical model
  • Behavioral: AP
    Attention placebo
  • Experimental: Tailored Intervention (TI)
    Tailored intervention based on the transtheoretical model
    Intervention: Behavioral: TI
  • Placebo Comparator: Attention Placebo (AP)
    Attention Placebo
    Intervention: Behavioral: AP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01122394
CDP 09-414
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Jennifer P Friedberg, PhD Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
VA Office of Research and Development
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP