Comparing Hypertension Remote Monitoring Evaluation Redesign

NCT06113458 | Enrolling By Invitation DMC

• 1 other identifier: P0564385
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in systolic BP (clinic)

  Clinic-based BP readings in EHR

  Baseline, 6 months

Secondary Outcomes (5)

• Change in systolic BP (home)

  Baseline, 6 months

• Patient activation and satisfaction

  Baseline, 6 months

• Number of participants with BP control

  Baseline, 6 months

• Medication intensification when BP is uncontrolled

  Baseline, 6 months

• Patient-reported medication adherence

  Baseline, 6 months

Study Arms (4)

Standard and One-time Training

ACTIVE COMPARATOR

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

Behavioral: Standard and One-time Training

Standard and Practice Facilitation

EXPERIMENTAL

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

Behavioral: Standard and Practice Facilitation

High-intensity and One-time Training

EXPERIMENTAL

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

Behavioral: High-intensity and One-time Training

High-intensity and Practice Facilitation

EXPERIMENTAL

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

Behavioral: High-intensity and Practice Facilitation

Interventions

Standard and One-time Training 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 One-time Training

Standard and Practice Facilitation 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.

Standard and Practice Facilitation

High-intensity and One-time Training 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 One-time Training

High-intensity and Practice Facilitation 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.

High-intensity and Practice Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (2)

• Tieu L, Khoong EC, Shah ND, Gosdin MM, Wang SJ, Sharma A, Abtahi N, Stern RJ, Zhou C, Sarkar U, Lyles CR; CHARMED Consortium. Applying behavior change theory to intervention design: promoting clinic-level implementation of self-measured blood pressure monitoring in safety net primary care settings. Transl Behav Med. 2026 Jan 7;16(1):ibaf094. doi: 10.1093/tbm/ibaf094.

  PMID: 41723583 DERIVED

• 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.

  PMID: 40086748 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Urmimala Sarkar

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: October 21, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)