Comparing Hypertension Remote Monitoring Evaluation Redesign (CHARMED)

January 21, 2026 updated by: University of California, San Francisco
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • Any sex/gender
  • Any race or ethnicity
  • Have hypertension or high blood pressure (BP) (BP >=140/90 mmHg at least twice in the previous 18 months)
  • Can read and write English or Spanish
  • Be able to provide consent

Exclusion Criteria:

• We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:

  • Pregnancy
  • Lactating/nursing
  • Dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard and One-time Training
Patient level: Standard, automatic reminders Clinic level: One-time training
Behavioral: Standard and One-time Training

Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.

Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
Experimental: Standard and Practice Facilitation
Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching
Behavioral: Standard and Practice Facilitation

Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring.

Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.
Experimental: High-intensity and One-time Training
Patient level: Personalized feedback Clinic level: One-time training
Behavioral: High-intensity and One-time Training

Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.

Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
Experimental: High-intensity and Practice Facilitation
Patient level: Personalized feedback Clinic level: Regular, ongoing coaching
Behavioral: High-intensity and Practice Facilitation

Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring.

Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic BP (clinic)
Time Frame: Baseline, 6 months
Clinic-based BP readings in EHR
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic BP (home)
Time Frame: Baseline, 6 months
Home-based BP readings
Baseline, 6 months
Patient activation and satisfaction
Time Frame: Baseline, 6 months
Patients will complete the Patient Assessment of Chronic Illness Care (PACIC) survey of 20 questions regarding elements of the care of their chronic condition(s) over the last six months. Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "Almost Never" and 5 signifying "Almost Always".
Baseline, 6 months
Number of participants with BP control
Time Frame: Baseline, 6 months
<140/90mmHg, at the patient level within the EHR
Baseline, 6 months
Medication intensification when BP is uncontrolled
Time Frame: Baseline, 6 months
Number of classes of anti-hypertensive medications prescribed per patient
Baseline, 6 months
Patient-reported medication adherence
Time Frame: Baseline, 6 months
Patients will complete the 4-item Krousel-Wood Medication Adherence Scale (M-Wood-MAS-4). The scale score is calculated by summing the points for the 4 questions (scale score ranges from 0 to 4, with higher score indicating worse adherence); low adherence on the K-Wood-MAS-4 is defined as a score ≥1.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Urmimala Sarkar, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0564385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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