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Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?
This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure with telemetry | Experimental | Home blood pressure monitor with telemetry |
|
| Blood pressure without telemetry | Active Comparator | Home blood pressure self monitor without telemetry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure monitor with telemetry | Device | Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Systolic Blood Pressure | Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months. | Baseline, 6 months |
| Mean Change in Diastolic Blood Pressure | Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months. | Baseline, 6 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick North, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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Participants were recruited and enrolled at the Mayo Clinic in Rochester, Minnesota from March 2011 to October 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Pressure With Telemetry | Blood pressure monitor with telemetry blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager |
| FG001 | Blood Pressure Without Telemetry | Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Pressure With Telemetry | Blood pressure monitor with telemetry blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager |
| BG001 | Blood Pressure Without Telemetry |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is indicated in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Systolic Blood Pressure | Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months. | Posted | Mean | 95% Confidence Interval | Millimeters of Mercury | Baseline, 6 months |
|
Baseline to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Pressure With Telemetry | Blood pressure monitor with telemetry blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frederick North | Mayo Clinic | 507-284-5164 | North.Frederick@mayo.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| D013686 | Telemetry |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D008991 | Monitoring, Physiologic |
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|
| Home blood pressure monitor without telemetry | Device | Self monitor of blood pressure without telemetry |
|
|
Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Mean Change in Diastolic Blood Pressure | Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months. | Posted | Mean | 95% Confidence Interval | Millimeters of Mercury | Baseline, 6 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Blood Pressure Without Telemetry | Blood pressure self monitor without telemetry Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry | 0 | 25 | 0 | 25 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |