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Enrolling by invitation NCT06113458

Comparing Hypertension Remote Monitoring Evaluation Redesign

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard and One-time Training, Standard and Practice Facilitation, High-intensity and One-time Training, High-intensity and Practice Facilitation.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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.
  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Change in systolic BP (clinic) [Time frame: Baseline, 6 months]
Secondary outcome measures (5)
  • Change in systolic BP (home) [Time frame: Baseline, 6 months]
  • Patient activation and satisfaction [Time frame: Baseline, 6 months]
  • Number of participants with BP control [Time frame: Baseline, 6 months]
  • Medication intensification when BP is uncontrolled [Time frame: Baseline, 6 months]
  • Patient-reported medication adherence [Time frame: Baseline, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Zuckerberg San Francisco General Hospital — San Francisco

Publications

  • 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
  • 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

Identifiers

NCT: NCT06113458 · P0564385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗