Trial Outcomes & Findings for App-based Remote Blood Pressure Monitoring (NCT NCT05595629)
NCT ID: NCT05595629
Last Updated: 2025-02-19
Results Overview
Number of participants who adhere to recommended blood pressure check after hospital discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
3-10 days postpartum
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Text-message Based Remote Blood Pressure Monitoring
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
App-based Remote Blood Pressure Monitoring
Baseline characteristics by cohort
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32 years
n=5 Participants
|
31 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-10 days postpartumNumber of participants who adhere to recommended blood pressure check after hospital discharge
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Blood Pressure Ascertainment
|
40 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Within 30 days of hospital discharge, patient is readmitted for complications related to hypertension or preeclampsiaReadmission rate for HTN/preeclampsia
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Postpartum Readmission for Hypertension or Preeclampsia
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From randomization until 6 weeks postpartumMedication initiation/titration, postpartum blood pressure goal of \<150/100
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Adherence to Evidence-based Practice
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From randomization until 6 weeks postpartumStroke, seizure/eclampsia, acute fatty liver of pregnancy, posterior reversible encephalopathy syndrome, pulmonary edema, heart failure, hemolysis elevated liver enzymes and low platelets, placental abruption, postpartum hemorrhage, acute kidney injury, transaminitis
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Postpartum Severe Maternal Morbidity Composite
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartumPatient preference of treatment group
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
"Using Any Number From 0 to 10 Where 0 is the Worst Possible Experience and 10 is the Best Possible Experience, Please Rate Your Experience in the Postpartum Hypertension Program"
|
10 score on a scale
Interval 9.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: Assessed at randomization and at 40 days postpartum, reported at 40 days postpartumExtent to which participant regrets participating in a treatment group. To help interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.
Outcome measures
| Measure |
Text-message Based Remote Blood Pressure Monitoring
n=60 Participants
Women in this group will receive current standard of care: remote blood pressure monitoring via text message. Specifically, they will receive automatic blood pressure cuffs, instructions how to obtain their blood pressures and log them into our Electronic Medical Record, and contact information for the nurse practitioner and community health worker managing the program. The NP will respond via text message to each individual measurement with instructions as to next steps.
text-message based remote blood pressure monitoring: Participants will receive automatic blood pressure cuffs and instructions as to how to upload their measurements to the Electronic Medical Record.
|
App-based Remote Blood Pressure Monitoring
n=59 Participants
Women in this group will receive a Bluetooth-enabled automatic blood pressure cuff that synchs automatically to a smartphone application that incorporates Artificial Intelligence to respond to each recorded measurements with recommended next steps and also document the measurement and response in a secure platform. This affiliated smartphone application will also contain education on hypertension management. Upon receipt of the blood pressure cuff, participants will be instructed to set up the program/app.
App-based remote blood pressure monitoring: Fully synched bluetooth-enabled remote blood pressure monitoring using a smartphone application. The digital health company, Twistle, has modified an existing postpartum hypertension pathway in their app according to our hospital's management algorithm.
|
|---|---|---|
|
Decisional Regret Scale
|
5 score on a scale
Interval 0.0 to 25.0
|
0 score on a scale
Interval 0.0 to 15.0
|
Adverse Events
Text-message Based Remote Blood Pressure Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
App-based Remote Blood Pressure Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Adam Lewkowitz
Women & Infants Hospital of Rhode Island
Phone: 401-274-1122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place