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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Blood Pressure Monitoring, Home
• Intervention / Treatment: Behavioral: BP monitor use training and app training; Behavioral: SMS reminders to take blood pressure; Behavioral: Education about self-management of hypertension; Behavioral: Educational text messages that encourage seeking support from a support person; Behavioral: Group classes; Behavioral: Online patient portal enrollment and training; Behavioral: Involvement of caregiver or support person

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 Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (two clinic BP readings ≥140/90 mmHg within the previous 18 months)
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-Intensity (Usual Care); Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials. Clinic level: training on standardized workflows and EHR tools, audit and feedback	Behavioral: BP monitor use training and app training; Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.; Behavioral: SMS reminders to take blood pressure; Patients will receive reminders via SMS to take their blood pressure.; Behavioral: Education about self-management of hypertension; One-time training with action planning, access to website with language concordant patient education, and educational text messages; Behavioral: Online patient portal enrollment and training; Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.
Experimental: High-Intensity; Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person. Clinic level: training on standardized workflows and EHR tools, audit and feedback	Behavioral: BP monitor use training and app training; Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.; Behavioral: SMS reminders to take blood pressure; Patients will receive reminders via SMS to take their blood pressure.; Behavioral: Education about self-management of hypertension; One-time training with action planning, access to website with language concordant patient education, and educational text messages; Behavioral: Educational text messages that encourage seeking support from a support person; Educational text messages about behavioral changes that explicitly encourage seeking support from a support person; Behavioral: Group classes; Patients will be asked to attend in-person or online group education classes on hypertension management; Behavioral: Online patient portal enrollment and training; Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.; Behavioral: Involvement of caregiver or support person; Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinic systolic BP		Baseline, 12 months, 18 months
BP Control	Clinic patients with EHR recorded BP < 140/90	Monthly (-6 to 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Systolic BP (SBP)	Home SBP for enrolled participants	Baseline, 12 months, 18 months
Patient Adoption	Number of SMBP values per participant	12 months
Patient Activation	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).	Baseline, 12 months
BP Control	Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values	Baseline, 12 months, 18 months
Clinic adoption	Clinic patients with EHR documented patient reported BP	Monthly (-6 to 18 months)
Costs	Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies	During trial; 12 months
Reach	Percent of participants who actively participate in SMBP monitoring	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Beth Israel Deaconess Medical Center; University of California, Davis; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Elaine Khoong, MD, MS, University of California, San Francisco

Publications and helpful links

General Publications

• Khoong EC, Kim HC, Li J, Larreynaga J, Luna I, Yang A, Kazi DS, Lyles CR, McCulloch C, Rahman SB, Sarkar U, Curtis N. Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations (InSPIRED): A study protocol. Contemp Clin Trials. 2025 Nov;158:108101. doi: 10.1016/j.cct.2025.108101. Epub 2025 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: INSPIRED
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Hypertension; Respiratory Aspiration
• Other Study ID Numbers: 24-42092; R18HS029817 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No