Enrolling by invitation NCT06113458
Comparing Hypertension Remote Monitoring Evaluation Redesign
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 →
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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