Trial Outcomes & Findings for Mobile Technology for Blood Pressure Management (NCT NCT04841317)

NCT ID: NCT04841317

Last Updated: 2024-03-22

Results Overview

Change in systolic and diastolic blood pressure (SBP and DBP).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Assessed at baseline and week 12
• Results posted on: 2024-03-22

Participant Flow

31 participants signed informed consent; 30 were allocated to the study arm.

Participant milestones

Measure	Blood Pressure Intervention Participants use a home blood pressure monitoring cuff for 12 weeks, integrated with a mobile application to allow their clinician to remotely view and manage blood pressure.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobile Technology for Blood Pressure Management

Baseline characteristics by cohort

Measure	Blood Pressure Intervention n=30 Participants Participants use a home blood pressure monitoring cuff for 12 weeks, integrated with a mobile application to allow their clinician to remotely view and manage blood pressure.
Age, Continuous	52.87 years STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	11 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants
Systolic Blood Pressure (SBP)	135 mmHg STANDARD_DEVIATION 10.01 • n=5 Participants
Diastolic Blood Pressure (DBP)	86.2 mmHg STANDARD_DEVIATION 8.5 • n=5 Participants
Weight	84.82 kg STANDARD_DEVIATION 16.9 • n=5 Participants
Body Mass Index (BMI)	28.14 kg/m^2 STANDARD_DEVIATION 5.09 • n=5 Participants
Chronic Kidney Disease (CKD)	1 Participants n=5 Participants
Sodium	141 mmol/L STANDARD_DEVIATION 2 • n=5 Participants
Potassium	4.3 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants
Creatinine	0.99 mg/dL STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: Assessed at baseline and week 12

Change in systolic and diastolic blood pressure (SBP and DBP).

Outcome measures

Measure	Blood Pressure Intervention n=30 Participants Participants use a home blood pressure monitoring cuff for 12 weeks, integrated with a mobile application to allow their clinician to remotely view and manage blood pressure.
Change in Blood Pressure SBP	-14.5 mmHg Interval -19.2 to -9.8
Change in Blood Pressure DBP	-6.3 mmHg Interval -10.2 to -6.3

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who completed the survey

A survey regarding usability and feedback about the intervention completed by participants. Questions 1 through 5 were rated on a scale of 1 (strongly disagree) to 7 (strongly agree); question 6 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful).

Outcome measures

Measure	Blood Pressure Intervention n=11 Participants Participants use a home blood pressure monitoring cuff for 12 weeks, integrated with a mobile application to allow their clinician to remotely view and manage blood pressure.
Participant Survey Q1: I consider myself to be technology savvy	5 score on a scale Standard Deviation 2.1
Participant Survey Q2: I found the blood pressure cuff easy to use	6.2 score on a scale Standard Deviation 0.75
Participant Survey Q3: I found it helpful to receive reminders to monitor my blood pressure	4.9 score on a scale Standard Deviation 1.76
Participant Survey Q4: I made blood pressure measurement readings without difficulty	6.2 score on a scale Standard Deviation 0.75
Participant Survey Q5: I found the app and blood pressure cuff convenient to manage my blood pressure	5.2 score on a scale Standard Deviation 1.94
Participant Survey Q6: I am able to lower my blood pressure into a healthy range	1.9 score on a scale Standard Deviation 1.14

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who completed the survey

A survey regarding usability and feedback about the intervention completed by physicians. Physicians provided survey responses, but were not enrolled in the study. Questions 1, 2, and 3 were rated on a scale of 1 (strongly agree) to 7 (strongly disagree); question 4 was rated on a scale of 1 (extremely confident) to 5 (extremely doubtful); question 5 was rated on a scale of 1 (extremely pleased) to 7 (extremely displeased).

Outcome measures

Measure	Blood Pressure Intervention n=1 Participants Participants use a home blood pressure monitoring cuff for 12 weeks, integrated with a mobile application to allow their clinician to remotely view and manage blood pressure.
Physician Survey Q1: I consider myself to be technology savvy	5 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Physician Survey Q2: I found the dashboard helpful to view and manage patient blood pressure data	5 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Physician Survey Q3: Using this system blood pressure management is more efficient compared to usual care	2 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Physician Survey Q4: This system will be useful to control my patients' blood pressure to a healthy range	2 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1
Physician Survey Q5: How would you rate your overall satisfaction with the care provided by the Dashboard?	5 score on a scale Standard Deviation NA Standard deviation not calculable for n of 1

Adverse Events

Blood Pressure Intervention

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

Paul J. Wang, MD

Stanford University

Phone: (650) 723-7111

Email: Paul.J.Wang@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place