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Do Home Monitors Improve Blood Pressure Control?

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ClinicalTrials.gov Identifier: NCT01579136
Recruitment Status : Terminated (Lack of subjects)
First Posted : April 17, 2012
Last Update Posted : December 24, 2012
Information provided by (Responsible Party):

April 12, 2012
April 17, 2012
December 24, 2012
December 2011
December 2012   (Final data collection date for primary outcome measure)
change in blood pressure over time [ Time Frame: baseline and 3 months ]
We are measuring the change in blood pressure between 2 groups: the intervention group which will be using home blood pressure monitors and the control group which will get care as usual for their blood pressure.
Same as current
Complete list of historical versions of study NCT01579136 on ClinicalTrials.gov Archive Site
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Do Home Monitors Improve Blood Pressure Control?
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The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Hypertension
  • Diabetes Mellitus
Behavioral: Home blood pressure monitor
The patients using home monitors checked their blood pressure on Monday, Wed, and Friday. They took 2 measurements 5 minutes apart after sitting 5 minutes in the left arm.
Other Name: Home monitor: Omron BP760 upper arm monitor
  • No Intervention: Control group
    This group will not get a home blood pressure monitor.
  • Experimental: Home monitors
    This group will be given a home blood pressure monitor to use.
    Intervention: Behavioral: Home blood pressure monitor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • over 18 years old,
  • diabetes as defined by HgA1C over 6.5%,
  • uncontrolled blood pressure (SBP > 130 and or DBP > 80)

Exclusion Criteria:

  • pregnancy,
  • transplanted organ,
  • MI/CHF/CVA within 3 months,
  • dialysis,
  • arrhythmia,
  • metastatic cancer,
  • dementia,
  • visual or hearing difficulties
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Karen Weber, DO, FACP, Exempla Saint Joseph Hospital
Exempla Saint Joseph Hospital
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Exempla Saint Joseph Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP