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Technology-enabled Management Versus Usual Care for Blood Pressure (HrtEx)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Hypertension Management System
Usual Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring High blood pressure, Digital Health Mobile Technology, Cardiovascular risk, Clinical Research, Medications

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Health Technology

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Defined Daily Dose (DDD)
Change in defined daily dose (DDD)

Secondary Outcome Measures

Systolic Blood Pressure (SBP)
Change in home SBP
Diastolic blood pressure (DBP)
Change in home diastolic blood pressure (DBP)
Antihypertensive Drugs
Change in number of antihypertensive drugs
Systolic Blood Pressure (SBP)
Change in home SBP
Physician Survey
Change in Survey score in Likert scale: Hypertension care and satisfaction
Clinician inertia
Proportion of visits with blood pressure above 130/80 mm Hg where medication was not intensified

Full Information

First Posted
July 20, 2022
Last Updated
August 27, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05479461
Brief Title
Technology-enabled Management Versus Usual Care for Blood Pressure
Acronym
HrtEx
Official Title
A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
High blood pressure, Digital Health Mobile Technology, Cardiovascular risk, Clinical Research, Medications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health Technology
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Digital Hypertension Management System
Intervention Description
Mobile health technology using physician- directed, semi-automated management of hypertension
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
The participants will receive usual care
Primary Outcome Measure Information:
Title
Defined Daily Dose (DDD)
Description
Change in defined daily dose (DDD)
Time Frame
Visit 1 (Baseline), Visit-3 (6 Month follow up)
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure (SBP)
Description
Change in home SBP
Time Frame
Visit-1 (Baseline), Visit-3 (6 Month follow up)
Title
Diastolic blood pressure (DBP)
Description
Change in home diastolic blood pressure (DBP)
Time Frame
Visit-1 (Baseline), Visit-3 (6 Month follow up)
Title
Antihypertensive Drugs
Description
Change in number of antihypertensive drugs
Time Frame
Visit-1 (Baseline), Visit-3 (6 Month follow up)
Title
Systolic Blood Pressure (SBP)
Description
Change in home SBP
Time Frame
Visit-1 (Baseline), Visit -2 (3 Month follow up)
Title
Physician Survey
Description
Change in Survey score in Likert scale: Hypertension care and satisfaction
Time Frame
Visit 1 (Baseline), Visit-3 (6 Month follow up)
Title
Clinician inertia
Description
Proportion of visits with blood pressure above 130/80 mm Hg where medication was not intensified
Time Frame
Visit 1 (Baseline), Visit-3 (6 Month follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul J Wang, MD
Phone
(650) 723-9363
Email
pjwang@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karma Lhamo, MSc
Email
karmalh@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Wang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Wang, M.D.
Phone
650-723-9363
Email
pjwang@stanford.edu
First Name & Middle Initial & Last Name & Degree
Mario Funes Hernandez, M.D.
Email
mfunes@stanford.edu
First Name & Middle Initial & Last Name & Degree
Paul Wang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Technology-enabled Management Versus Usual Care for Blood Pressure

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