Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations

Not Applicable

Recruiting

• Conditions: Blood Pressure Monitoring, Home; Hypertension

• Registration Number: NCT06871462
• Lead Sponsor: University of California, San Francisco

Brief Summary

This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.

Detailed Description

This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record \[EHR\] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-12
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-11-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 18 years old/order
• Any sex or gender
• Any race or ethnicity
• Must be receiving primary care at any of the six enrolled clinics
• Have uncontrolled hypertension (BP >=140/90 mmHg at any two encounters in the previous 18 months, including the most recent encounter prior to enrollment)
• Can read and write English, Spanish, or Cantonese
• Be able to provide consent
• Must own a cell phone that receives SMS or text messages

Exclusion Criteria

• Those with conditions that might complicate remote BP monitoring:

  • Pregnancy (and 12 months postpartum)
  • Acute myocardial infarction or stroke in the last 12 months
  • End-stage renal disease on dialysis
  • Stage D heart failure
  • Active treatment for cancer (except for nonmelanoma skin cancers)
  • Pacemaker use

• Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in clinic systolic BP	Baseline, 12 months, 18 months
BP Control	Monthly (-6 to 18 months)	Clinic patients with EHR recorded BP \< 140/90

Secondary Outcome Measures

Name	Time	Method
BP Control	Baseline, 12 months, 18 months	Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values
Home Systolic BP (SBP)	Baseline, 12 months, 18 months	Home SBP for enrolled participants
Patient Adoption	12 months	Number of SMBP values per participant
Clinic adoption	Monthly (-6 to 18 months)	Clinic patients with EHR documented patient reported BP
Reach	12 months	Percent of participants who actively participate in SMBP monitoring
Costs	During trial; 12 months	Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies
Patient Activation	Baseline, 12 months	Patient Assessment of Chronic Illness Care (PACIC) - Minimum score: 1, Maximum score: 5. The PACIC is scored by summing participants' responses across all 20 items then dividing by 20, the number of items in the scale. Thus, scores on the PACIC range from 1 to 5 with higher scores indicating a better outcome (patient's perception of greater involvement in self-management and receipt of chronic care counseling).

Trial Locations

Locations (1)

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