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Mobile Technology for Blood Pressure Management

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04841317
Collaborator
American Heart Association (Other)
50
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Mobile technology intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementing a Mobile Technology-Based System for Physician-Directed Remote Management of Hypertension: A Pilot Study
Anticipated Study Start Date :
Mar 31, 2021
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Combination Product: Mobile technology intervention
Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [12 weeks]

    Systolic and diastolic blood pressures for each participant measured by home blood pressure monitoring

  2. Participant survey [12 weeks]

    A survey regarding usability and feedback about the intervention completed by participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • American Heart Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Paul Wang, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT04841317
Other Study ID Numbers:
  • 59671
  • 20FRN35360178
First Posted:
Apr 12, 2021
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Apr 12, 2021