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A Behavioral Intervention To Improve Hypertension Control In Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00286754
First received: February 1, 2006
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: January 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Behavioral: SMI
Behavioral: HEI
Behavioral: UC

  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
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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
Stage-matched Intervention (SM) 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
Health Education Intervention (HEI) 6 monthly phone calls of non-tailored counseling for diet, medication and exercise
Usual Care (UC) treatment as usual with no additional counseling

Participant Flow:   Overall Study
    Stage-matched Intervention (SM)   Health Education Intervention (HEI)   Usual Care (UC)
STARTED   176   177   180 
COMPLETED   156   159   170 
NOT COMPLETED   20   18   10 
Adverse Event                2                2                3 
Withdrawal by Subject                6                2                0 
Lost to Follow-up                12                14                6 
Moved out of state                0                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.
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Reporting Groups
  Description
Stage-Matched Intervention (SMI) 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
Health Education Intervention (HEI) 6 monthly calls of nontailored counseling for diet, medication and exercise
Usual Care (UC) treatment as usual for hypertension
Total Total of all reporting groups

Baseline Measures
   Stage-Matched Intervention (SMI)   Health Education Intervention (HEI)   Usual Care (UC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   177   180   533 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Age and Standard Deviation   66.4  (8.8)   66.5  (12.8)   65.4  (10.2)   66.1  (18.5) 
Gender 
[Units: Participants]
       
Female   2   1   4   7 
Male   174   176   176   526 
Race/Ethnicity, Customized 
[Units: Participants]
       
White (non-Hispanic)   81   60   71   212 
Black (non-Hispanic)   65   77   70   212 
Hispanic   24   29   29   82 
Other   6   11   10   27 
Marital status 
[Units: Participants]
       
Married   59   67   70   196 
Not Married   117   110   110   337 
Education 
[Units: Participants]
       
High school graduate or below   72   89   87   248 
Some college or higher   104   88   93   285 
Employment status 
[Units: Participants]
       
Employed   29   41   41   111 
Not employed   147   136   139   422 
Campus 
[Units: Participants]
       
Manhattan campus   96   96   97   289 
Brooklyn campus   80   81   83   244 
Smoking 
[Units: Participants]
       
Current smoker   35   32   32   99 
Current non-smoker   141   145   148   434 
Body mass index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.5  (5.2)   31.2  (5.8)   30.0  (4.8)   30.5  (5.3) 
Blood pressure control [1] 
[Units: Participants]
       
BP controlled   75   72   80   227 
BP not controlled   101   105   100   306 
[1] Controlled BP was defined as systolic BP (SBP) less than130 mm Hg or Diastolic BP (DBP) less than 80 mm Hg in diabetes mellitus or chronic kidney disease, or SBP less than140 mm Hg or DBP less than 90 mm Hg in all others as per the BP guidelines at the time of the study.
Diabetes Mellitus [1] 
[Units: Participants]
       
Diabetes mellitus   71   83   81   235 
No diabetes mellitus   105   94   99   298 
[1] From chart review
Ischemic Heart Disease (IHD) [1] 
[Units: Participants]
       
History of IHD   23   22   23   68 
No history of IHD   153   155   157   465 
[1] self-reported
History of revascularization [1] 
[Units: Participants]
       
History of revascularization   27   28   31   86 
No history of revascularization   149   149   149   447 
[1] self-reported
Hyperlipidemia [1] 
[Units: Participants]
       
Hyperlipidemia   39   38   52   129 
No hyperlipidemia   137   139   128   404 
[1] Hyperlipidemia was defined as LDL cholesterol of greater than or equal to 100 mg/dL from laboratory results
Estimated glomerular filtration rate (EGFR) 
[Units: mL/min/1.73m^2]
Mean (Standard Deviation)
 79.9  (25.5)   83.2  (46.3)   80.6  (28.4)   81.3  (35.8) 
Systolic Blood Pressure, mm Mg 
[Units: Mm Hg]
Mean (Standard Deviation)
 136.0  (11.8)   137.2  (17.7)   137.0  (12.9)   136.7  (15.5) 
Diastolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 75.5  (9.3)   76.1  (11.6)   75.0  (11.1)   75.5  (11.6) 
Aerobic exercise 
[Units: Hours per week]
Mean (Standard Deviation)
 5.3  (8.1)   4.5  (5.9)   5.0  (6.7)   4.9  (6.7) 
Medication adherence by Morisky scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.4  (0.93)   3.2  (0.67)   3.3  (0.94)   3.3  (0.88) 
[1] Morisky medication-taking scale is a 4-item questionnaire scored from 0-4, with 4 being most adherent and less than 4 being considered nonadherent
Number of antihypertensive medications 
[Units: Medications]
Mean (Standard Deviation)
 2.7  (1.5)   2.8  (1.3)   2.7  (1.3)   2.7  (1.4) 
Diet stage of change [1] 
[Units: Participants]
       
Action or Maintenance   69   67   70   206 
Precontemplation, Contemplation or Preparation   107   110   110   327 
[1] The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.
Exercise Stage of Change [1] 
[Units: Participants]
       
Action or Maintenance   125   110   108   343 
Precontemplation, Contemplation, or Preparation   51   67   72   190 
[1] The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence19, 20 due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.
Medication Stage of Change [1] 
[Units: Participants]
       
Action or Maintenance   164   170   166   500 
Precontemplation, Contemplation or Preparation   12   7   14   33 
[1] The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.


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

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

3.  Secondary:   Change in Proportion With BP Under Control From Baseline to 6 Months   [ Time Frame: 6 months ]

4.  Secondary:   Change in Systolic Blood Pressure From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Change in Number of Cardio Exercise Hours From Baseline to 6 Months   [ Time Frame: baseline and 6 months ]

6.  Secondary:   Change in Morisky Score From Baseline to 6 Months   [ Time Frame: baseline and 6 months ]

7.  Secondary:   Diet Stage of Change   [ Time Frame: 6 months ]

8.  Secondary:   Exercise Stage of Change   [ Time Frame: 6 months ]

9.  Secondary:   Medication Stage of Change   [ 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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