Comparing Hypertension Remote Monitoring Evaluation Redesign

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: High-intensity and One-time Training; Behavioral: Standard and Practice Facilitation; Behavioral: Standard and One-time Training; Behavioral: High-intensity and Practice Facilitation

• Registration Number: NCT06113458
• Lead Sponsor: University of California, San Francisco

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Study Start: 2024-10-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2028-04
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High-intensity and One-time Training	High-intensity and One-time Training	Patient level: Personalized feedback Clinic level: One-time training
Standard and Practice Facilitation	Standard and Practice Facilitation	Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching
Standard and One-time Training	Standard and One-time Training	Patient level: Standard, automatic reminders Clinic level: One-time training
High-intensity and Practice Facilitation	High-intensity and Practice Facilitation	Patient level: Personalized feedback Clinic level: Regular, ongoing coaching

Primary Outcome Measures

Name	Time	Method
Change in systolic BP (clinic)	Baseline, 6 months	Clinic-based BP readings in EHR

Secondary Outcome Measures

Name	Time	Method
Change in systolic BP (home)	Baseline, 6 months	Home-based BP readings
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.
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

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States