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NCT01579136 Clinical Trial

Do Home Monitors Improve Blood Pressure Control?

Hypertension Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01579136
Other study ID # 201147
Secondary ID
Status Terminated
Phase N/A
First received April 12, 2012
Last updated December 20, 2012
Start date December 2011
Est. completion date December 2012

Study information
Verified date December 2012
Source Exempla Saint Joseph Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 26
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Caritas Clinic, Exempla Saint Joseph Hospital Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
Exempla Saint Joseph Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. baseline and 3 months No
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