Comparing Hypertension Remote Monitoring Evaluation Redesign

Hypertension Clinical Trial

— CHARMED  

Official title:

Comparing Hypertension Remote Monitoring Evaluation Redesign

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06113458
• Other study ID #: P0564385
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2024
• Est. completion date: July 2028

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: July 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic BP (clinic)	Clinic-based BP readings in EHR	Baseline, 6 months
Secondary	Change in systolic BP (home)	Home-based BP readings	Baseline, 6 months
Secondary	Patient activation and satisfaction	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".	Baseline, 6 months
Secondary	Number of participants with BP control	<140/90mmHg, at the patient level within the EHR	Baseline, 6 months
Secondary	Medication intensification when BP is uncontrolled	Number of classes of anti-hypertensive medications prescribed per patient	Baseline, 6 months
Secondary	Patient-reported medication adherence	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.	Baseline, 6 months