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| ID | Type | Description | Link |
|---|---|---|---|
| 20FRN35360178 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm: Blood pressure intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile technology intervention | Combination Product | Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Change in systolic and diastolic blood pressure (SBP and DBP). | 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). | 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29133356 | Background | Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available. | |
| 12493255 |
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31 participants signed informed consent; 30 were allocated to the study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Blood Pressure | Change in systolic and diastolic blood pressure (SBP and DBP). | Posted | Mean | 95% Confidence Interval | mmHg | Assessed at baseline and week 12 |
|
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul J. Wang, MD | Stanford University | (650) 723-7111 | Paul.J.Wang@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2021 | Feb 5, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Background |
| Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. |
| 19454737 | Background | Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009 May 19;338:b1665. doi: 10.1136/bmj.b1665. |
| 23989679 | Background | Jaffe MG, Lee GA, Young JD, Sidney S, Go AS. Improved blood pressure control associated with a large-scale hypertension program. JAMA. 2013 Aug 21;310(7):699-705. doi: 10.1001/jama.2013.108769. |
| 22615116 | Background | Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51-7. doi: 10.1161/HYPERTENSIONAHA.111.188409. Epub 2012 May 21. |
| 17765133 | Background | Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. doi: 10.1016/j.amjhyper.2007.03.020. |
| 31732293 | Background | Casey DE Jr, Thomas RJ, Bhalla V, Commodore-Mensah Y, Heidenreich PA, Kolte D, Muntner P, Smith SC Jr, Spertus JA, Windle JR, Wozniak GD, Ziaeian B. 2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2019 Nov 26;74(21):2661-2706. doi: 10.1016/j.jacc.2019.10.001. No abstract available. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Chronic Kidney Disease (CKD) | Count of Participants | Participants |
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| Sodium | Mean | Standard Deviation | mmol/L |
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| Potassium | Mean | Standard Deviation | mmol/L |
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| Creatinine | Mean | Standard Deviation | mg/dL |
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| 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). | Participants who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| 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). | Participants who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| 0 |
| 18 |
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| 18 |
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| 18 |
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| Q4: I made blood pressure measurement readings without difficulty |
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| Q5: I found the app and blood pressure cuff convenient to manage my blood pressure |
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| Q6: I am able to lower my blood pressure into a healthy range |
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| Q3: Using this system blood pressure management is more efficient compared to usual care |
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| Q4: This system will be useful to control my patients' blood pressure to a healthy range |
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| Q5: How would you rate your overall satisfaction with the care provided by the Dashboard? |
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