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Trial of Low and High Intensity Strategies to Maintain BP Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00760552
First received: September 24, 2008
Last updated: April 6, 2015
Last verified: November 2014
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Hypertension
Interventions: Other: High Intensity Intervention
Other: Low Intensity Intervention
Other: All- 6 month pharmacist intervention

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
249 total were enrolled. 122 had controlled BP and did not participate in the trial. of the 127 who participated, 4 dropped prior to randomization.

Reporting Groups
  Description
Arm 1

VA patients with uncontrolled HTN.

High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.

Arm 2

VA patients with uncontrolled HTN.

Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     61     62  
COMPLETED     48     52  
NOT COMPLETED     13     10  
Death                 2                 0  
Lost to Follow-up                 11                 10  



  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
Arm 1

VA patients with uncontrolled HTN.

High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP.

Arm 2

VA patients with uncontrolled HTN.

Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  61     62     123  
Age  
[units: years]
Mean (Standard Deviation)
  63.6  (11.2)     66.0  (10.3)     64.8  (10.8)  
Gender  
[units: participants]
     
Female     1     2     3  
Male     60     60     120  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     57     57     114  
More than one race     0     0     0  
Unknown or Not Reported     4     5     9  
Region of Enrollment  
[units: participants]
     
United States     61     62     123  



  Outcome Measures

1.  Primary:   Blood Pressure Change   [ Time Frame: Measured at Baseline, and 6,12,18,24, and 30 months post baseline. ]


  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: Dr. Gary Rosenthal
Organization: Iowa City VA Health Care System
phone: 319-338-0581
e-mail: gary-rosenthal@uiowa.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00760552     History of Changes
Other Study ID Numbers: IIR 07-145
Study First Received: September 24, 2008
Results First Received: December 3, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government