A Behavioral Intervention To Improve Hypertension Control In Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
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  
Number of Participants  
[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  
Diabetes Mellitus [2]
[units: participants]
       
Diabetes mellitus     71     83     81     235  
No diabetes mellitus     105     94     99     298  
Ischemic Heart Disease (IHD) [3]
[units: participants]
       
History of IHD     23     22     23     68  
No history of IHD     153     155     157     465  
History of revascularization [3]
[units: participants]
       
History of revascularization     27     28     31     86  
No history of revascularization     149     149     149     447  
Hyperlipidemia [4]
[units: participants]
       
Hyperlipidemia     39     38     52     129  
No hyperlipidemia     137     139     128     404  
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 [5]
[units: units on a scale]
Mean (Standard Deviation)
  3.4  (0.93)     3.2  (0.67)     3.3  (0.94)     3.3  (0.88)  
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 [6]
[units: participants]
       
Action or Maintenance     69     67     70     206  
Precontemplation, Contemplation or Preparation     107     110     110     327  
Exercise Stage of Change [7]
[units: participants]
       
Action or Maintenance     125     110     108     343  
Precontemplation, Contemplation, or Preparation     51     67     72     190  
Medication Stage of Change [8]
[units: participants]
       
Action or Maintenance     164     170     166     500  
Precontemplation, Contemplation or Preparation     12     7     14     33  
[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.
[2] From chart review
[3] self-reported
[4] Hyperlipidemia was defined as LDL cholesterol of greater than or equal to 100 mg/dL from laboratory results
[5] 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
[6] 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.
[7] 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.
[8] 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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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sundar Natarajan, MD, Staff Physician
Organization: Department of Veterans Affairs
phone: 212-686-7500 ext 3287
e-mail: Sundar.Natarajan@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00286754     History of Changes
Other Study ID Numbers: IIR 04-170
Study First Received: February 1, 2006
Results First Received: January 21, 2015
Last Updated: May 8, 2015
Health Authority: United States: Federal Government