CHARMED: Comparing Hypertension Remote Monitoring Evaluation Redesign

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06113458

Collaborator

Patient-Centered Outcomes Research Institute (Other)

2,500

Enrollment

Location

Arms

Anticipated Duration (Months)

55.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: Standard and One-time Training Behavioral: Standard and Practice Facilitation Behavioral: High-intensity and One-time Training Behavioral: High-intensity and Practice Facilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing Hypertension Remote Monitoring Evaluation Redesign

Anticipated Study Start Date :

Oct 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2028

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard and One-time Training Patient level: Standard, automatic reminders Clinic level: One-time training	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.
Experimental: Standard and Practice Facilitation Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching	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.
Experimental: High-intensity and One-time Training Patient level: Personalized feedback Clinic level: One-time training	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.
Experimental: High-intensity and Practice Facilitation Patient level: Personalized feedback Clinic level: Regular, ongoing coaching	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.

Outcome Measures

Primary Outcome Measures

Change in systolic BP (clinic) [Baseline, 6 months]
Clinic-based BP readings in EHR

Secondary Outcome Measures

Change in systolic BP (home) [Baseline, 6 months]
Home-based BP readings
Patient activation and satisfaction [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".
Number of participants with BP control [Baseline, 6 months]
<140/90mmHg, at the patient level within the EHR
Medication intensification when BP is uncontrolled [Baseline, 6 months]
Number of classes of anti-hypertensive medications prescribed per patient
Patient-reported medication adherence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

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

Investigators

Principal Investigator: Urmimala Sarkar, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT06113458

Other Study ID Numbers:

P0564385

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Nov 7, 2023