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Clinical Trials/NCT04841317
NCT04841317
Completed
Not Applicable

Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study

Stanford University1 site in 1 country31 target enrollmentMarch 31, 2021
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Stanford University
Enrollment
31
Locations
1
Primary Endpoint
Participant Survey
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2021
End Date
December 7, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Wang

Professor of Medicine

Stanford University

Eligibility Criteria

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

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).

Study Sites (1)

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