Study Stopped
Lack of subjects
Do Home Monitors Improve Blood Pressure Control?
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Dec 2011
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 12, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 24, 2012
December 1, 2012
1 year
April 12, 2012
December 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control group
NO INTERVENTIONThis group will not get a home blood pressure monitor.
Home monitors
EXPERIMENTALThis group will be given a home blood pressure monitor to use.
Interventions
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.
Eligibility Criteria
You may qualify if:
- over 18 years old,
- diabetes as defined by HgA1C over 6.5%,
- uncontrolled blood pressure (SBP \> 130 and or DBP \> 80)
You may not qualify if:
- pregnancy,
- transplanted organ,
- MI/CHF/CVA within 3 months,
- dialysis,
- arrhythmia,
- metastatic cancer,
- dementia,
- visual or hearing difficulties
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caritas Clinic, Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director Outpatient Services, Internal Medicine Residency Program
Study Record Dates
First Submitted
April 12, 2012
First Posted
April 17, 2012
Study Start
December 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 24, 2012
Record last verified: 2012-12