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Remote BP Monitoring in the PP Period

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ClinicalTrials.gov Identifier: NCT03728790
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Philips Healthcare
New York Presbyterian Hospital
Information provided by (Responsible Party):
Leslie Moroz, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypertensive Disorder of Pregnancy
Intervention Device: Remote Patient Monitoring
Enrollment 213
Recruitment Details Subjects were recruited from the inpatient postpartum service after delivery. Recruitment began on November 9, 2018. The last participant was recruited on July 10, 2019.
Pre-assignment Details 426 women with hypertension were assessed for eligibility. 123 women were excluded: 1 was under 18 years old, 49 resided outside of New York State, 22 received care at a non-participating office, 48 were planning on following up at another institution, 2 spoke a language other than English or Spanish and 1 was unable to use the tablet. 90 declined.
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Period Title: Overall Study
Started 112 101
Completed 112 101
Not Completed 0 0
Arm/Group Title Usual Care Remote Patient Monitoring Total
Hide Arm/Group Description Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Total of all reporting groups
Overall Number of Baseline Participants 112 101 213
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 112 participants 101 participants 213 participants
32
(29 to 36)
33
(28 to 36)
33
(26 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Female
112
 100.0%
101
 100.0%
213
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Hispanic or Latino
67
  59.8%
53
  52.5%
120
  56.3%
Not Hispanic or Latino
45
  40.2%
48
  47.5%
93
  43.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
   9.8%
5
   5.0%
16
   7.5%
Native Hawaiian or Other Pacific Islander
1
   0.9%
0
   0.0%
1
   0.5%
Black or African American
32
  28.6%
32
  31.7%
64
  30.0%
White
48
  42.9%
55
  54.5%
103
  48.4%
More than one race
1
   0.9%
0
   0.0%
1
   0.5%
Unknown or Not Reported
19
  17.0%
9
   8.9%
28
  13.1%
Multiparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
81
  72.3%
83
  82.2%
164
  77.0%
Married/Partnered  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
76 89 165
Highest level of education   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Graduate School
35
  31.3%
26
  25.7%
61
  28.6%
College
25
  22.3%
26
  25.7%
51
  23.9%
Some college
16
  14.3%
18
  17.8%
34
  16.0%
High school
26
  23.2%
27
  26.7%
53
  24.9%
Some high school
6
   5.4%
3
   3.0%
9
   4.2%
Elementary school
1
   0.9%
1
   1.0%
2
   0.9%
Declined to answer
3
   2.7%
0
   0.0%
3
   1.4%
[1]
Measure Description: Highest level of maternal education completed
Employment status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Employed
75
  67.0%
66
  65.3%
141
  66.2%
Unemployed
33
  29.5%
30
  29.7%
63
  29.6%
Self-employed
4
   3.6%
5
   5.0%
9
   4.2%
Type of insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Public Insurance
47
  42.0%
41
  40.6%
88
  41.3%
Private Insurance
65
  58.0%
60
  59.4%
125
  58.7%
Born outside of United States  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
54
  48.2%
49
  48.5%
103
  48.4%
Religion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Christian
57
  50.9%
55
  54.5%
112
  52.6%
Jewish
4
   3.6%
7
   6.9%
11
   5.2%
Muslim
4
   3.6%
2
   2.0%
6
   2.8%
Jehovah's Witness
3
   2.7%
0
   0.0%
3
   1.4%
Hindu
0
   0.0%
2
   2.0%
2
   0.9%
None
37
  33.0%
34
  33.7%
71
  33.3%
Other
7
   6.3%
1
   1.0%
8
   3.8%
Type of prenatal care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Generalist
62
  55.4%
55
  54.5%
117
  54.9%
Maternal fetal medicine (MFM)
45
  40.2%
43
  42.6%
88
  41.3%
No prenatal care
5
   4.5%
3
   3.0%
8
   3.8%
Smoking status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Current Smokers
0
   0.0%
1
   1.0%
1
   0.5%
Former Smokers
6
   5.4%
5
   5.0%
11
   5.2%
Drug use status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Current users
0
   0.0%
1
   1.0%
1
   0.5%
Former users
6
   5.4%
1
   1.0%
7
   3.3%
Time of initiation of prenatal care  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
First trimester
84
  75.0%
82
  81.2%
166
  77.9%
Second trimester
24
  21.4%
15
  14.9%
39
  18.3%
Third trimester
1
   0.9%
2
   2.0%
3
   1.4%
Unknown
3
   2.7%
1
   1.0%
4
   1.9%
No prenatal care
0
   0.0%
1
   1.0%
1
   0.5%
Diabetes diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Type 1 Diabetes
1
   0.9%
0
   0.0%
1
   0.5%
Type 2 Diabetes
4
   3.6%
1
   1.0%
5
   2.3%
Gestational diabetes, diet controlled
5
   4.5%
8
   7.9%
13
   6.1%
Gestational diabetes, oral agents
1
   0.9%
4
   4.0%
5
   2.3%
Gestational diabetes, insulin
7
   6.3%
3
   3.0%
10
   4.7%
Gestational age at delivery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
20-23 6/7 weeks
0
   0.0%
1
   1.0%
1
   0.5%
24-27 6/7 weeks
3
   2.7%
1
   1.0%
4
   1.9%
28-33 6/7 weeks
12
  10.7%
8
   7.9%
20
   9.4%
34-36 6/7 weeks
16
  14.3%
20
  19.8%
36
  16.9%
37-38 6/7 weeks
52
  46.4%
42
  41.6%
94
  44.1%
39-40 6/7 weeks
26
  23.2%
29
  28.7%
55
  25.8%
>41 weeks
3
   2.7%
0
   0.0%
3
   1.4%
Type of delivery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Cesarean Delivery
56
  50.0%
57
  56.4%
113
  53.1%
Spontaneous Vaginal Delivery
53
  47.3%
43
  42.6%
96
  45.1%
Forceps-assisted Vaginal Delivery
3
   2.7%
1
   1.0%
4
   1.9%
Neonatal disposition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Fetal Demise
1
   0.9%
0
   0.0%
1
   0.5%
Neonatal Demise
1
   0.9%
0
   0.0%
1
   0.5%
Neonatal intensive care unit (NICU) admission
28
  25.0%
19
  18.8%
47
  22.1%
Type of hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
Chronic Hypertension
14
  12.5%
15
  14.9%
29
  13.6%
Superimposed preeclampsia
12
  10.7%
9
   8.9%
21
   9.9%
Gestational Hypertension
38
  33.9%
33
  32.7%
71
  33.3%
Preeclampsia without severe features
12
  10.7%
17
  16.8%
29
  13.6%
Preeclampsia with severe features/HELLP Syndrome
36
  32.1%
26
  25.7%
62
  29.1%
Eclampsia
0
   0.0%
1
   1.0%
1
   0.5%
Exposure to magnesium sulfate  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
44
  39.3%
34
  33.7%
78
  36.6%
Urgent antihypertensive medication antepartum or intrapartum  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
21
  18.8%
15
  14.9%
36
  16.9%
Discharged on antihypertensive medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 101 participants 213 participants
47
  42.0%
41
  40.6%
88
  41.3%
1.Primary Outcome
Title Blood Pressure (BP) Surveillance Adherence
Hide Description Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
Time Frame Up to 14 days from delivery hospitalization discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Median (Full Range)
Unit of Measure: percentage of recommended BPs reported
0.0
(0.0 to 100.0)
61.1
(0.0 to 92.3)
2.Secondary Outcome
Title Elevated Blood Pressure Percentage
Hide Description Percentage of recorded blood pressure values at first outpatient blood pressure assessment that are elevated (>140 systolic or >90 diastolic)
Time Frame Up to 14 days from delivery hospitalization discharge
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Outpatient BP Assessment Within 14 Days
Hide Description Number of participants who had a documented outpatient BP assessment within 14 days of hospital discharge
Time Frame Up to 14 days from delivery hospitalization discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
69
  61.6%
59
  58.4%
4.Secondary Outcome
Title Incidence of BP Elevations
Hide Description Incidence of elevated blood pressure at outpatient blood pressure assessment
Time Frame Up to 14 days from delivery hospitalization discharge
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants With Outpatient PP Assessment
Hide Description Number of participants who had an outpatient postpartum (PP) assessment
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
88
  78.6%
82
  81.2%
6.Secondary Outcome
Title Incidence of BP Elevations
Hide Description Incidence of elevated blood pressure (BP) at the postpartum visit
Time Frame Up to 8 weeks from delivery
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Medication Initiation
Hide Description Time to initiation of antihypertensive medications (in patients who were not on medications at time of discharge)
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The analyzed population only includes participants in each arm who were not on medications at the time of discharge.
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 65 60
Median (Inter-Quartile Range)
Unit of Measure: days
6.5
(2.75 to 18)
6.0
(3 to 13)
8.Secondary Outcome
Title Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge
Hide Description Number of participants discharged from delivery hospitalization without antihypertensive therapy, who were subsequently started on antihypertensive therapy
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 65 60
Measure Type: Count of Participants
Unit of Measure: Participants
10
  15.4%
24
  40.0%
9.Secondary Outcome
Title Number of Participants Readmitted
Hide Description Number of participants who were readmitted after delivery hospitalization discharge
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
7
   6.3%
13
  12.9%
10.Secondary Outcome
Title Number of Participants With ED Visit
Hide Description Number of participants who had an Emergency Department (ED) visit after delivery hospitalization discharge
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
17
  15.2%
25
  24.8%
11.Secondary Outcome
Title Number of Participants Who Developed Preeclampsia-associated Complications
Hide Description Number of patients who experienced preeclampsia-related morbidity (eg: stroke, seizure, posterior reversible encephalopathy syndrome (PRES) , pulmonary edema, liver function abnormality, reversible cerebral vasoconstriction syndrome (RCVS) , renal insufficiency, thrombocytopenia) after delivery hospitalization discharge.
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.6%
9
   8.9%
12.Secondary Outcome
Title Number of Participants Referred to Primary Care for Continued Blood Pressure Management
Hide Description Number of participants who require a referral to primary care physicians for continued blood pressure management after being discharged from obstetric care at the postpartum visit
Time Frame Up to 8 weeks from delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description:
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

Overall Number of Participants Analyzed 112 101
Measure Type: Count of Participants
Unit of Measure: Participants
31
  27.7%
38
  37.6%
13.Secondary Outcome
Title Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
Hide Description The modified TSUQ is an 18-item survey that will be used to measure patient satisfaction with remote blood pressure monitoring. Individuals score each of the items based on their satisfaction, with 1=strongly disagree to 5=strongly agree. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction.
Time Frame Up to 8 weeks from delivery
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change in Score on the Philips Program Survey
Hide Description The Philips program start survey is a 4 question survey to gauge how patients relate to their care and their doctors prior to initiation of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups. The Philips program end survey is a 6 question survey to gauge how patients related to their care and their doctors after the completion of their blood pressure monitoring program. Individuals score each of the items based on the perception of their care, with 5 being best and 1 being worst. The responses would then be used to calculate a mean score on the 5-point scale, with 5 indicating the most satisfaction, and compared between the 2 groups.
Time Frame Up to 8 weeks from delivery
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Communications
Hide Description Elevated blood pressures that led to communication with an obstetric provider
Time Frame Up to 14 days post delivery hospitalization discharge
Outcome Measure Data Not Reported
Time Frame Adverse event data were collected through the end of the study period, which ended at the time of participants' postpartum visit or 8 weeks postpartum, whichever came first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Remote Patient Monitoring
Hide Arm/Group Description Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.

Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.

Remote Patient Monitoring: Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.

All-Cause Mortality
Usual Care Remote Patient Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      0/101 (0.00%)    
Hide Serious Adverse Events
Usual Care Remote Patient Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/112 (6.25%)      13/101 (12.87%)    
Pregnancy, puerperium and perinatal conditions     
Readmission  [1]  7/112 (6.25%)  7 13/101 (12.87%)  13
Indicates events were collected by systematic assessment
[1]
This metric refers to hospital readmissions after delivery hospitalization discharge. This was also a secondary outcome metric of this study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Remote Patient Monitoring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/101 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leslie Moroz
Organization: Columbia University
Phone: 646-532-8208
EMail: lm3000@cumc.columbia.edu
Publications:
Layout table for additonal information
Responsible Party: Leslie Moroz, Columbia University
ClinicalTrials.gov Identifier: NCT03728790    
Other Study ID Numbers: AAAS0065
First Submitted: October 28, 2018
First Posted: November 2, 2018
Results First Submitted: July 24, 2020
Results First Posted: September 28, 2020
Last Update Posted: September 28, 2020