Do Home Monitors Improve Blood Pressure Control?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579136
Recruitment Status : Terminated (Lack of subjects)
First Posted : April 17, 2012
Last Update Posted : December 24, 2012
Information provided by (Responsible Party):
Karen Weber, DO, FACP, Exempla Saint Joseph Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus Behavioral: Home blood pressure monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01579136

United States, Colorado
Caritas Clinic, Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Exempla Saint Joseph Hospital

Responsible Party: Karen Weber, DO, FACP, Associate Director Outpatient Services, Internal Medicine Residency Program, Exempla Saint Joseph Hospital Identifier: NCT01579136     History of Changes
Other Study ID Numbers: 201147
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases