Technology-enabled Management Versus Usual Care for Blood Pressure

Hypertension Clinical Trial

— HrtEx  

Official title:

A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479461
• Other study ID #: 63700
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Paul J Wang, MD
• Phone: (650) 723-9363
• Email: pjwang[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two arm parallel randomized clinical trial

Description:

Patients will be randomized 1:1 to receive mobile technology intervention versus usual care. Half of patients from a clinician team will receive the intervention and half will receive usual care. We aim to recruit at least 200 patients, 100 in each arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 30-90 yrs.

• Smartphone ownership

• Office SBP: = 140 mm Hg

• = 2 current anti-HTN meds

• Able to add or dose-increase at least 2 of the following classes of medications:

ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose)

• English or Spanish-speakers

Exclusion Criteria:

• Heart failure with reduced ejection fraction (EF < 40%)

• ESRD (GFR <15)

• Renal replacement therapy

• Pregnant

• Myocardial infarction or stroke within preceding 6 months

• Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months

• Prior solid organ transplantation

• At the clinical discretion of the investigators

• Enrolled in another clinical study

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Digital Hypertension Management System
Mobile health technology using physician- directed, semi-automated management of hypertension
• Usual Care
The participants will receive usual care

Locations

Country	Name	City	State
United States	Stanford Health Care	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defined Daily Dose (DDD)	Change in defined daily dose (DDD)	Visit 1 (Baseline), Visit-3 (6 Month follow up)
Secondary	Systolic Blood Pressure (SBP)	Change in home SBP	Visit-1 (Baseline), Visit-3 (6 Month follow up)
Secondary	Diastolic blood pressure (DBP)	Change in home diastolic blood pressure (DBP)	Visit-1 (Baseline), Visit-3 (6 Month follow up)
Secondary	Antihypertensive Drugs	Change in number of antihypertensive drugs	Visit-1 (Baseline), Visit-3 (6 Month follow up)
Secondary	Systolic Blood Pressure (SBP)	Change in home SBP	Visit-1 (Baseline), Visit -2 (3 Month follow up)
Secondary	Physician Survey	Change in Survey score in Likert scale: Hypertension care and satisfaction	Visit 1 (Baseline), Visit-3 (6 Month follow up)
Secondary	Clinician inertia	Proportion of visits with blood pressure above 130/80 mm Hg where medication was not intensified	Visit 1 (Baseline), Visit-3 (6 Month follow up)