Back to resultsDo Home Monitors Improve Blood Pressure Control?
Primary Purpose
Hypertension, Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home blood pressure monitor
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension
Eligibility 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
Sites / Locations
- Caritas Clinic, Exempla Saint Joseph Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Home monitors
Arm Description
This group will not get a home blood pressure monitor.
This group will be given a home blood pressure monitor to use.
Outcomes
Primary Outcome Measures
change in blood pressure over time
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01579136
First Posted
April 12, 2012
Last Updated
December 20, 2012
Sponsor
Exempla Saint Joseph Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01579136
Brief Title
Do Home Monitors Improve Blood Pressure Control?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of subjects
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Exempla Saint Joseph Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will not get a home blood pressure monitor.
Arm Title
Home monitors
Arm Type
Experimental
Arm Description
This group will be given a home blood pressure monitor to use.
Intervention Type
Behavioral
Intervention Name(s)
Home blood pressure monitor
Other Intervention Name(s)
Home monitor: Omron BP760 upper arm monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in blood pressure over time
Description
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.
Time Frame
baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Caritas Clinic, Exempla Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
12. IPD Sharing Statement
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Do Home Monitors Improve Blood Pressure Control?
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