Comparing Hypertension Remote Monitoring Evaluation Redesign

NCT ID: NCT06113458

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2028-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard and One-time Training

Patient level: Standard, automatic reminders Clinic level: One-time training

Group Type ACTIVE_COMPARATOR

Standard and One-time Training

Intervention Type BEHAVIORAL

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.

Standard and Practice Facilitation

Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching

Group Type EXPERIMENTAL

Standard and Practice Facilitation

Intervention Type BEHAVIORAL

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.

High-intensity and One-time Training

Patient level: Personalized feedback Clinic level: One-time training

Group Type EXPERIMENTAL

High-intensity and One-time Training

Intervention Type BEHAVIORAL

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.

High-intensity and Practice Facilitation

Patient level: Personalized feedback Clinic level: Regular, ongoing coaching

Group Type EXPERIMENTAL

High-intensity and Practice Facilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urmimala Sarkar

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

References

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Lyles CR, Khoong EC, Stern RJ, Abtahi N, Sharma AE, Pletcher MJ, Xia F, Garcia F, Shah ND, Tieu L, Sarkar U; CHARMED consortium. Championing Hypertension Remote Monitoring for Equity and Dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol. Contemp Clin Trials. 2025 May;152:107879. doi: 10.1016/j.cct.2025.107879. Epub 2025 Mar 12.

Reference Type DERIVED
PMID: 40086748 (View on PubMed)

Other Identifiers

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P0564385

Identifier Type: -

Identifier Source: org_study_id