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Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)

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ClinicalTrials.gov Identifier: NCT00781365
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : July 14, 2014
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthPartners Institute

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
Hide 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
[1]
completed both 6 and 12 month follow up
Arm/Group Title Usual Care Telemonitoring Intervention Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 228 participants 450 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
152
  68.5%
147
  64.5%
299
  66.4%
>=65 years
70
  31.5%
81
  35.5%
151
  33.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 228 participants 450 participants
60.2  (12.2) 62.0  (11.7) 61.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 228 participants 450 participants
Female
98
  44.1%
103
  45.2%
201
  44.7%
Male
124
  55.9%
125
  54.8%
249
  55.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 228 participants 450 participants
Hispanic or Latino
9
   4.1%
1
   0.4%
10
   2.2%
Not Hispanic or Latino
213
  95.9%
227
  99.6%
440
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
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
1.Primary Outcome
Title Blood Pressure Control
Hide Description Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
Time Frame Baseline, 6 months, 12 months, 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Telemonitoring Intervention
Hide 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.

Overall Number of Participants Analyzed 222 228
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
0
(0 to 0)
0
(0 to 0)
6 Months
45.2
(39.2 to 51.3)
71.8
(65.6 to 77.3)
12 Months
52.8
(45.4 to 60.2)
71.2
(62.0 to 78.9)
18 Months
57.1
(51.5 to 62.6)
71.8
(65.0 to 77.8)
2.Primary Outcome
Title Mean Systolic Blood Pressure
Hide Description Systolic blood pressure at baseline and 4 time points
Time Frame Baseline, 6 months, 12 months, 18 months, 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Telemonitoring Intervention
Hide 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.

Overall Number of Participants Analyzed 222 228
Mean (95% Confidence Interval)
Unit of Measure: mmHg
Baseline
147.7
(145.8 to 149.5)
148.2
(146.3 to 150.0)
6 Months
136.9
(134.6 to 139.2)
126.7
(124.4 to 129.0)
12 Months
134.8
(132.5 to 137.2)
125.7
(123.4 to 128.0)
18 Months
133.0
(130.4 to 135.5)
126.9
(124.3 to 129.4)
54 Months
131.7
(128.8 to 134.6)
131.2
(128.3 to 134.1)
3.Primary Outcome
Title Mean Diastolic Blood Pressure
Hide Description Mean diastolic blood pressure at baseline and 4 time points
Time Frame Baseline, 6 months, 12 months, 18 months, 54 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Telemonitoring Intervention
Hide 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.

Overall Number of Participants Analyzed 222 228
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
Baseline
85.1
(82.9 to 87.3)
84.4
(82.3 to 86.6)
6 Months
81.7
(79.5 to 84.0)
75.0
(72.9 to 77.2)
12 Months
80.8
(78.5 to 83.2)
75.1
(72.8 to 77.4)
18 Months
78.7
(76.6 to 80.9)
75.1
(73.0 to 77.2)
54 Months
79.1
(76.8 to 81.4)
77.8
(75.5 to 80.1)
Time Frame Events were reported at 6, 12, and 18 month clinic visits
Adverse Event Reporting Description All events self-reported by participant
 
Arm/Group Title Usual Care Telemonitoring Intervention
Hide 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.

All-Cause Mortality
Usual Care Telemonitoring Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Usual Care Telemonitoring Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/222 (16.67%)      30/228 (13.16%)    
Blood and lymphatic system disorders     
Anemia * [1]  4/222 (1.80%)  4 2/228 (0.88%)  2
Cardiac disorders     
Chest pain, atypical * [2]  0/222 (0.00%)  0 4/228 (1.75%)  4
Hypertensive crisis *  1/222 (0.45%)  1 1/228 (0.44%)  1
Stable angina *  0/222 (0.00%)  0 1/228 (0.44%)  1
Atrial fibrillation *  1/222 (0.45%)  1 1/228 (0.44%)  1
Myocardial Infarction *  8/222 (3.60%)  8 0/228 (0.00%)  0
Endocrine disorders     
Hyperglycemia *  1/222 (0.45%)  1 0/228 (0.00%)  0
Gastrointestinal disorders     
Acute pancreatitis *  0/222 (0.00%)  0 1/228 (0.44%)  1
Small bowel obstruction *  1/222 (0.45%)  1 1/228 (0.44%)  3
Gastrointestinal bleed *  2/222 (0.90%)  2 1/228 (0.44%)  1
General disorders     
Dehydration *  1/222 (0.45%)  1 0/228 (0.00%)  0
Chest pain, non-cardiac, non-specific *  4/222 (1.80%)  4 3/228 (1.32%)  4
Hepatobiliary disorders     
Ascites *  1/222 (0.45%)  1 0/228 (0.00%)  0
Acute abdominal pain * [3]  1/222 (0.45%)  1 0/228 (0.00%)  0
Infections and infestations     
Appendicitis *  0/222 (0.00%)  0 1/228 (0.44%)  1
Sepsis *  1/222 (0.45%)  1 0/228 (0.00%)  0
Peri-operative wound infection *  1/222 (0.45%)  1 0/228 (0.00%)  0
Injury, poisoning and procedural complications     
Overdose, toxicity, or withdrawal * [4]  4/222 (1.80%)  4 1/228 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Acute back pain *  1/222 (0.45%)  1 1/228 (0.44%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer *  0/222 (0.00%)  0 1/228 (0.44%)  1
Nervous system disorders     
Hashimoto's encephalopathy *  0/222 (0.00%)  0 1/228 (0.44%)  1
Psychiatric disorders     
Pyschiatric hospitalization * [5]  2/222 (0.90%)  2 1/228 (0.44%)  1
Reproductive system and breast disorders     
Prostate resection *  0/222 (0.00%)  0 2/228 (0.88%)  2
Respiratory, thoracic and mediastinal disorders     
Worsening Chronic Obstructive Pulmonary Disease (COPD) *  1/222 (0.45%)  2 2/228 (0.88%)  2
Skin and subcutaneous tissue disorders     
Cellulitis *  1/222 (0.45%)  1 1/228 (0.44%)  1
Surgical and medical procedures     
Knee, hip, or shoulder arthroplasty *  2/222 (0.90%)  2 4/228 (1.75%)  4
Spinal decompression/fusion *  6/222 (2.70%)  6 3/222 (1.35%)  3
Fracture repair * [6]  1/222 (0.45%)  1 2/228 (0.88%)  2
Hernia repair *  1/222 (0.45%)  1 1/228 (0.44%)  1
Thyroidectomy *  1/222 (0.45%)  1 0/228 (0.00%)  0
Hysterectomy *  1/222 (0.45%)  1 0/228 (0.00%)  0
Cholecystectomy *  2/222 (0.90%)  2 0/228 (0.00%)  0
Hemorrhoid surgery *  1/222 (0.45%)  1 0/228 (0.00%)  0
Bladder suspension *  1/222 (0.45%)  1 0/228 (0.00%)  0
Vascular disorders     
Cerebrovascular accident (stroke) *  5/222 (2.25%)  5 2/228 (0.88%)  2
Hypotension with syncope * [7]  0/222 (0.00%)  0 3/228 (1.32%)  3
Transient Ischemic Attack *  3/222 (1.35%)  3 0/228 (0.00%)  0
Peripheral artery disease *  1/222 (0.45%)  1 0/228 (0.00%)  0
Coronary artery disease *  1/222 (0.45%)  1 0/228 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Secondary to other conditions (renal failure, Chronic Obstructive Pulmonary Disease(COPD ), GI blood loss, anal fissure)
[2]
Cardiac cause not ruled out (history of cardiac disease, hypertensive crisis)
[3]
Secondary to end stage liver disease
[4]
Alcohol and narcotic overdose, toxicity, withdrawal
[5]
Psychiatric hospital admissions: depression, alcohol abuse, psychosis, nonspecific altered mental state
[6]
Hospitalizations and surgery related to bone fracture
[7]
Hospitalization for hypotension with syncope
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Telemonitoring Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/222 (3.60%)      5/228 (2.19%)    
Cardiac disorders     
Hypotension, dizziness, near syncope * [1]  1/222 (0.45%)  1 3/228 (1.32%)  3
Injury, poisoning and procedural complications     
Allergic reaction * [2]  1/222 (0.45%)  1 0/228 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer *  1/222 (0.45%)  1 0/228 (0.00%)  0
Prostate Cancer *  0/222 (0.00%)  0 1/228 (0.44%)  1
Renal and urinary disorders     
Uretral stent change *  0/222 (0.00%)  0 1/228 (0.44%)  3
Skin and subcutaneous tissue disorders     
Erythema nodosum *  1/222 (0.45%)  1 0/228 (0.00%)  0
Vascular disorders     
Hypertensive crisis * [3]  2/222 (0.90%)  2 0/228 (0.00%)  0
Hypertension * [4]  1/222 (0.45%)  1 0/228 (0.00%)  0
Allergic vasculitis * [5]  1/222 (0.45%)  1 0/228 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
ER or urgent care visit for low blood pressure, near syncope
[2]
ER visit for allergic reaction possibly related to antihypertensive drugs
[3]
ER or urgent care visit for high blood pressure
[4]
New diagnosis
[5]
Secondary to bladder infection treatment
1) Response rate: 1 in 7 patients solicited by mail responded;of those screened, 1 in 4 eligible. 2) Participants were well-educated, had high income levels, 3) 1 integrated health care system, 4) study was not blinded.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Karen Margolis, MD MPH
Organization: HealthPartners Institute for Education and Research
Phone: 952-967-7301
EMail: karen.l.margolis@healthpartners.com
Layout table for additonal information
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