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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
Results First Received: July 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Stroke
TIA
Hypertension
Hyperlipidemia
Interventions: Behavioral: TI
Behavioral: AP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from a prior American Heart Association-funded study testing the effectiveness of a 6-mo TI vs. AP. Participants were recruited at completion of the AHA study to participate in the current study for an additional 6 months. They continued to receive the intervention to which they were originally assigned in the AHA study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tailored Intervention (TI) Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
Attention Placebo (AP) General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)

Participant Flow:   Overall Study
    Tailored Intervention (TI)   Attention Placebo (AP)
STARTED   66   74 
COMPLETED   63   70 
NOT COMPLETED   3   4 
Withdrawal by Subject                1                1 
Lost to Follow-up                2                2 
Adverse Event                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tailored Intervention (TI) Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
Attention Placebo (AP) General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Total Total of all reporting groups

Baseline Measures
   Tailored Intervention (TI)   Attention Placebo (AP)   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   74   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.38  (9.86)   68.73  (10.30)   67.62  (10.13) 
Gender 
[Units: Participants]
     
Female   2   0   2 
Male   64   74   138 
Race/Ethnicity, Customized 
[Units: Participants]
     
White (non-Hispanic)   21   27   48 
Black/African American (non-Hispanic)   35   34   69 
Hispanic/Latino   6   9   15 
Other   3   4   7 
Refused   1   0   1 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Dietary Sodium   [ Time Frame: 6 months ]

3.  Secondary:   Total Cholesterol/High Density Lipoprotein Ratio   [ Time Frame: 6 months ]

4.  Secondary:   Exercise Adherence   [ Time Frame: 6 months ]

5.  Secondary:   Antihypertensive/ Lipid-lowering Medication Adherence   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Friedberg, Ph.D.
Organization: VA New York Harbor Healthcare System
phone: 212-951-3314
e-mail: jennifer.friedberg@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01122394     History of Changes
Other Study ID Numbers: CDP 09-414
Study First Received: May 10, 2010
Results First Received: July 15, 2016
Last Updated: August 26, 2016