Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Participant Survey
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Single-arm: Blood pressure intervention
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.
Intervention: Mobile technology intervention (Combination Product)
Outcomes
Primary Outcomes
Participant Survey
Time Frame: 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
Time Frame: 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).
Change in Blood Pressure
Time Frame: Assessed at baseline and week 12
Change in systolic and diastolic blood pressure (SBP and DBP).
Secondary Outcomes
No secondary outcomes reported
Investigators
Paul Wang
Professor of Medicine
Stanford University