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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Stroke
TIA
Hypertension
Hyperlipidemia
Interventions Behavioral: TI
Behavioral: AP
Enrollment 140
Recruitment Details 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  
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Period Title: Overall Study
Started 66 74
Completed 63 70
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             2             2
Adverse Event             0             1
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP) Total
Hide Arm/Group Description Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening) Total of all reporting groups
Overall Number of Baseline Participants 66 74 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 74 participants 140 participants
66.38  (9.86) 68.73  (10.30) 67.62  (10.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 74 participants 140 participants
Female
2
   3.0%
0
   0.0%
2
   1.4%
Male
64
  97.0%
74
 100.0%
138
  98.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 74 participants 140 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
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description:

Tailored intervention based on the transtheoretical model

TI: Tailored intervention based on the transtheoretical model

Attention Placebo

AP: Attention placebo

Overall Number of Participants Analyzed 54 59
Median (Inter-Quartile Range)
Unit of Measure: mm Hg
130.83
(119.5 to 144.83)
133.67
(114.5 to 144.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Intervention (TI), Attention Placebo (AP)
Comments Robust regressions were performed
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method robust regression
Comments controlling for provider clustering
2.Secondary Outcome
Title Dietary Sodium
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description:
Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Number of Participants Analyzed 63 70
Measure Type: Number
Unit of Measure: participants
pre-action 11 18
Action or Maintenance 52 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Intervention (TI), Attention Placebo (AP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Logistic
Comments This analysis includes participants in pre-action and action/maintenance
3.Secondary Outcome
Title Total Cholesterol/High Density Lipoprotein Ratio
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description:
Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Number of Participants Analyzed 60 71
Median (Inter-Quartile Range)
Unit of Measure: ratio
3.47
(2.8 to 4.25)
3.21
(2.8 to 3.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Intervention (TI), Attention Placebo (AP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Exercise Adherence
Hide Description Measured by 7-day Physical Activity Recall
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description:
Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Number of Participants Analyzed 63 70
Median (Inter-Quartile Range)
Unit of Measure: hours per week of cardio
2.50
(1.25 to 5.25)
2.75
(1 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Intervention (TI), Attention Placebo (AP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Secondary Outcome
Title Antihypertensive/ Lipid-lowering Medication Adherence
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description:
Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Number of Participants Analyzed 62 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.58  (0.76) 3.43  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Intervention (TI), Attention Placebo (AP)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tailored Intervention (TI) Attention Placebo (AP)
Hide Arm/Group Description Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
All-Cause Mortality
Tailored Intervention (TI) Attention Placebo (AP)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tailored Intervention (TI) Attention Placebo (AP)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/66 (1.52%)   2/74 (2.70%) 
Cardiac disorders     
Coronary Artery Bypass Graft *  1/66 (1.52%)  1/74 (1.35%) 
Nervous system disorders     
Stroke *  0/66 (0.00%)  1/74 (1.35%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tailored Intervention (TI) Attention Placebo (AP)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/66 (13.64%)   9/74 (12.16%) 
Musculoskeletal and connective tissue disorders     
Broken bone *  2/66 (3.03%)  2/74 (2.70%) 
Torn Ligament *  1/66 (1.52%)  1/74 (1.35%) 
Bone/Muscle injury *  6/66 (9.09%)  6/74 (8.11%) 
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01122394     History of Changes
Other Study ID Numbers: CDP 09-414
First Submitted: May 10, 2010
First Posted: May 13, 2010
Results First Submitted: July 15, 2016
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016