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Do Home Monitors Improve Blood Pressure Control?

This study has been terminated.
(Lack of subjects)
Sponsor:
Information provided by (Responsible Party):
Karen Weber, DO, FACP, Exempla Saint Joseph Hospital
ClinicalTrials.gov Identifier:
NCT01579136
First received: April 12, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Hypertension
Diabetes Mellitus
 Behavioral: Home blood pressure monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Exempla Saint Joseph Hospital:

Primary Outcome Measures:
  • change in blood pressure over time [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579136

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

No publications provided

Responsible Party: Karen Weber, DO, FACP, Associate Director Outpatient Services, Internal Medicine Residency Program, Exempla Saint Joseph Hospital
ClinicalTrials.gov Identifier: NCT01579136     History of Changes
Other Study ID Numbers: 201147
Study First Received: April 12, 2012
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013