An interventional study of Mobile technology intervention in Hypertension, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
The primary objective of this study is to assess the feasibility and effectiveness of a mobile-technology based system that integrates patient-facing and clinician-facing components to assist the management of hypertension.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 31 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will use a mobile technology system comprising of a remote home blood pressure monitoring cuff and a mobile application integrated with a clinician-facing component to view and manage remote blood pressures. Participants will use this for 12 weeks, with assessment of blood pressure outcomes and anonymous surveys regarding the technology at 12 weeks.
Combination Product: Mobile technology intervention
Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely
Change in Blood Pressure
Change in systolic and diastolic blood pressure (SBP and DBP).
Time frame: Assessed at baseline and week 12
Participant 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).
Time frame: 12 weeks
Physician 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).
Time frame: 12 weeks
| Milestone | Blood Pressure Intervention |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Change in systolic and diastolic blood pressure (SBP and DBP).
| mmHg | Blood Pressure Intervention |
|---|---|
| SBP | -14.5 (-19.2 to -9.8) |
| DBP | -6.3 (-10.2 to -6.3) |
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).
| score on a scale | Blood Pressure Intervention |
|---|---|
| Q1: I consider myself to be technology savvy | 5 ± 2.1 |
| Q2: I found the blood pressure cuff easy to use | 6.2 ± 0.75 |
| Q3: I found it helpful to receive reminders to monitor my blood pressure | 4.9 ± 1.76 |
| Q4: I made blood pressure measurement readings without difficulty | 6.2 ± 0.75 |
| Q5: I found the app and blood pressure cuff convenient to manage my blood pressure | 5.2 ± 1.94 |
| Q6: I am able to lower my blood pressure into a healthy range | 1.9 ± 1.14 |
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).
| score on a scale | Blood Pressure Intervention |
|---|---|
| Q1: I consider myself to be technology savvy | 5 ± NA |
| Q2: I found the dashboard helpful to view and manage patient blood pressure data | 5 ± NA |
| Q3: Using this system blood pressure management is more efficient compared to usual care | 2 ± NA |
| Q4: This system will be useful to control my patients' blood pressure to a healthy range | 2 ± NA |
| Q5: How would you rate your overall satisfaction with the care provided by the Dashboard? | 5 ± NA |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blood Pressure Intervention | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Blood Pressure Intervention |
|---|---|
| Mean | 52.87 ± 12.44 |
| Sex: Female, Male(Participants) | Blood Pressure Intervention |
|---|---|
| Female | 5 |
| Male | 25 |
| Race/Ethnicity, Customized(Participants) | Blood Pressure Intervention |
|---|---|
| Asian | 14 |
| Hispanic or Latino | 3 |
| Non-Hispanic Black | 2 |
| Non-Hispanic White | 11 |
| Region of Enrollment(Participants) | Blood Pressure Intervention |
|---|---|
| United States | 30 |
| Systolic Blood Pressure (SBP)(mmHg) | Blood Pressure Intervention |
|---|---|
| Mean | 135 ± 10.01 |
| Diastolic Blood Pressure (DBP)(mmHg) | Blood Pressure Intervention |
|---|---|
| Mean | 86.2 ± 8.5 |
| Weight(kg) | Blood Pressure Intervention |
|---|---|
| Mean | 84.82 ± 16.9 |
| Body Mass Index (BMI)(kg/m^2) | Blood Pressure Intervention |
|---|---|
| Mean | 28.14 ± 5.09 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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