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Enrolling by Invitation

NCT Number: NCT06113458

Comparing Hypertension Remote Monitoring Evaluation Redesign

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).

Enrolling by Invitation

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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 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.

Primary outcomes

  1. Change in systolic BP (clinic)

    Time frame: Baseline, 6 months

    Clinic-based BP readings in EHR

Secondary outcomes

  1. Change in systolic BP (home)

    Time frame: Baseline, 6 months

    Home-based BP readings

  2. 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".

  3. Number of participants with BP control

    Time frame: Baseline, 6 months

    <140/90mmHg, at the patient level within the EHR

  4. Medication intensification when BP is uncontrolled

    Time frame: Baseline, 6 months

    Number of classes of anti-hypertensive medications prescribed per patient

  5. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: CHARMED

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 2, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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