Comparing Hypertension Remote Monitoring Evaluation Redesign (CHARMED)

University of California San Francisco (UCSF)

Status: Invitation-only

Conditions: Hypertension

Treatments: Behavioral: Standard and Practice Facilitation; Behavioral: High-intensity and One-time Training; Behavioral: Standard and One-time Training; Behavioral: High-intensity and Practice Facilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06113458

P0564385

Details and patient eligibility

About

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).

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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2,500 participants in 4 patient groups

Standard and One-time Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard and One-time Training

Standard and Practice Facilitation

Experimental group

Description:

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

Treatment:

Behavioral: Standard and Practice Facilitation

High-intensity and One-time Training

Experimental group

Description:

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

Treatment:

Behavioral: High-intensity and One-time Training

High-intensity and Practice Facilitation

Experimental group

Description:

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

Treatment:

Behavioral: High-intensity and Practice Facilitation