Technology-enabled Management Versus Usual Care for Blood Pressure

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Other: Usual Care; Other: Digital Hypertension Management System

• Registration Number: NCT05479461
• Lead Sponsor: Stanford University

Brief Summary

Two arm parallel randomized clinical trial

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-29
• Study Start: 2023-06-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
Mobile Health Technology	Digital Hypertension Management System	-

Primary Outcome Measures

Name	Time	Method
Defined Daily Dose (DDD)	Visit 1 (Baseline), Visit-3 (6 Month follow up)	Change in defined daily dose (DDD)

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (SBP)	Visit-1 (Baseline), Visit -2 (3 Month follow up)	Change in home SBP
Antihypertensive Drugs	Visit-1 (Baseline), Visit-3 (6 Month follow up)	Change in number of antihypertensive drugs
Physician Survey	Visit 1 (Baseline), Visit-3 (6 Month follow up)	Change in Survey score in Likert scale: Hypertension care and satisfaction
Diastolic blood pressure (DBP)	Visit-1 (Baseline), Visit-3 (6 Month follow up)	Change in home diastolic blood pressure (DBP)
Clinician inertia	Visit 1 (Baseline), Visit-3 (6 Month follow up)	Proportion of visits with blood pressure above 130/80 mm Hg where medication was not intensified

Trial Locations

Locations (1)

Stanford Health Care; 🇺🇸 Palo Alto, California, United States