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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014