Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)
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| ClinicalTrials.gov Identifier: NCT00781365 |
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Recruitment Status :
Completed
First Posted : October 29, 2008
Results First Posted : July 14, 2014
Last Update Posted : April 13, 2017
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
| Condition |
Hypertension |
| Intervention |
Other: Telemonitors and pharmacy management |
| Enrollment | 450 |
| Recruitment Details | Recruitment was between March 2009-April 2011. We identified adult patients with elevated BP (systolic BP >140 or diastolic BP >90 mm Hg) at the two most recent primary care visits in the past year using electronic medical records. Patients received up to two mailings followed by phone calls. Further screening occurred in research clinic. |
| Pre-assignment Details | Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization). |
| Arm/Group Title | Telemonitoring Intervention | Usual Care |
|---|---|---|
 Arm/Group Description |
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments. Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist. |
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. |
| Period Title: Overall Study | ||
| Started | 228 | 222 |
| Completed | 194 [1] | 186 [1] |
| Not Completed | 34 | 36 |
| Reason Not Completed | ||
| Withdrawal by Subject | 13 | 8 |
| Did Not Attend Visit | 20 | 28 |
| Language barrier | 1 | 0 |
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[1]
completed both 6 and 12 month follow up
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| Arm/Group Title | Usual Care | Telemonitoring Intervention | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. |
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments. Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 222 | 228 | 450 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 222 participants | 228 participants | 450 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
152 68.5%
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147 64.5%
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299 66.4%
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| >=65 years |
70 31.5%
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81 35.5%
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151 33.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 222 participants | 228 participants | 450 participants | |
| 60.2 (12.2) | 62.0 (11.7) | 61.1 (12.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 222 participants | 228 participants | 450 participants | |
| Female |
98 44.1%
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103 45.2%
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201 44.7%
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| Male |
124 55.9%
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125 54.8%
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249 55.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 222 participants | 228 participants | 450 participants | |
| Hispanic or Latino |
9 4.1%
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1 0.4%
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10 2.2%
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| Not Hispanic or Latino |
213 95.9%
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227 99.6%
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440 97.8%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 222 participants | 228 participants | 450 participants |
| White | 177 | 191 | 368 | |
| Black or African American | 29 | 24 | 53 | |
| Asian | 3 | 4 | 7 | |
| Other | 13 | 9 | 22 | |
| Name/Title: | Dr. Karen Margolis, MD MPH |
| Organization: | HealthPartners Institute for Education and Research |
| Phone: | 952-967-7301 |
| EMail: | karen.l.margolis@healthpartners.com |
| Responsible Party: | HealthPartners Institute |
| ClinicalTrials.gov Identifier: | NCT00781365 |
| Other Study ID Numbers: |
07116 1R01HL090965 ( U.S. NIH Grant/Contract ) 2R01HL090965 ( U.S. NIH Grant/Contract ) |
| First Submitted: | October 28, 2008 |
| First Posted: | October 29, 2008 |
| Results First Submitted: | February 27, 2014 |
| Results First Posted: | July 14, 2014 |
| Last Update Posted: | April 13, 2017 |