Hypertension
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTMobile technology intervention
Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely
Sponsors
American Heart Association
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older with an established diagnosis of essential hypertension
Exclusion criteria
* Patients on more than 2 antihypertensives at time of enrollment * Clinical diagnosis of secondary hypertension, that is, hypertension due to a secondary cause, including but not limited to the following: * Renal artery stenosis * Primary hyperaldosteronism * Cushing syndrome * Coarctation of the aorta * Drug-induced hypertension * Pheochromocytoma * Obstructive sleep apnea * Hospitalization for malignant hypertension or severe hypertension (including stroke, cardiac events, acute kidney injury) in the preceding 6 months * Hospitalization for unstable angina or myocardial infarction in the preceding 6 months * Prior diagnosis of heart failure or cardiomyopathy * Stroke or transient ischemic attack within prior 6 months * Prior organ transplantation * Failure to obtain informed consent * Pregnant or currently trying to become pregnant * Patients who are enrolled in other research studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | Assessed at baseline and week 12 | Change in systolic and diastolic blood pressure (SBP and DBP). |
| Participant Survey | 12 weeks | 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). |
| Physician Survey | 12 weeks | 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). |
Countries
United States
Participant flow
Pre-assignment details
31 participants signed informed consent; 30 were allocated to the study arm.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Blood Pressure Intervention |
|---|---|
| Age, Continuous | 52.87 years STANDARD_DEVIATION 12.44 |
| Body Mass Index (BMI) | 28.14 kg/m^2 STANDARD_DEVIATION 5.09 |
| Chronic Kidney Disease (CKD) | 1 Participants |
| Creatinine | 0.99 mg/dL STANDARD_DEVIATION 0.2 |
| Diastolic Blood Pressure (DBP) | 86.2 mmHg STANDARD_DEVIATION 8.5 |
| Potassium | 4.3 mmol/L STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 11 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 25 Participants |
| Sodium | 141 mmol/L STANDARD_DEVIATION 2 |
| Systolic Blood Pressure (SBP) | 135 mmHg STANDARD_DEVIATION 10.01 |
| Weight | 84.82 kg STANDARD_DEVIATION 16.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in Blood Pressure
Change in systolic and diastolic blood pressure (SBP and DBP).
Time frame: Assessed at baseline and week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Blood Pressure Intervention | Change in Blood Pressure | SBP | -14.5 mmHg |
| Blood Pressure Intervention | Change in Blood Pressure | DBP | -6.3 mmHg |
Primary
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
Population: Participants who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blood Pressure Intervention | 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 |
| Blood Pressure Intervention | Participant Survey | Q1: I consider myself to be technology savvy | 5 score on a scale | Standard Deviation 2.1 |
| Blood Pressure Intervention | Participant Survey | Q2: I found the blood pressure cuff easy to use | 6.2 score on a scale | Standard Deviation 0.75 |
| Blood Pressure Intervention | Participant Survey | Q4: I made blood pressure measurement readings without difficulty | 6.2 score on a scale | Standard Deviation 0.75 |
| Blood Pressure Intervention | 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 |
| Blood Pressure Intervention | 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
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
Population: Participants who completed the survey
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Blood Pressure Intervention | Physician Survey | Q1: I consider myself to be technology savvy | 5 score on a scale |
| Blood Pressure Intervention | Physician Survey | Q2: I found the dashboard helpful to view and manage patient blood pressure data | 5 score on a scale |
| Blood Pressure Intervention | Physician Survey | Q3: Using this system blood pressure management is more efficient compared to usual care | 2 score on a scale |
| Blood Pressure Intervention | Physician Survey | Q4: This system will be useful to control my patients' blood pressure to a healthy range | 2 score on a scale |
| Blood Pressure Intervention | Physician Survey | Q5: How would you rate your overall satisfaction with the care provided by the Dashboard? | 5 score on a scale |