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

Tracking Information
First Received Date ^ICMJE	April 12, 2012
Last Updated Date	December 20, 2012
Start Date ^ICMJE	December 2011
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01579136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Do Home Monitors Improve Blood Pressure Control?
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Hypertension Diabetes Mellitus
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	26
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01579136
Other Study ID Numbers ^ICMJE	201147
Has Data Monitoring Committee	No
Responsible Party	Karen Weber, DO, FACP, Exempla Saint Joseph Hospital
Study Sponsor ^ICMJE	Exempla Saint Joseph Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Exempla Saint Joseph Hospital
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top