Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
INSPIRED
2 other identifiers
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
February 5, 2026
February 1, 2026
2.5 years
March 4, 2025
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
BP Control
Baseline, 12 months, 18 months
Home Systolic BP (SBP)
Baseline, 12 months, 18 months
Patient Adoption
12 months
Clinic adoption
Monthly (-6 to 18 months)
Reach
12 months
- +2 more secondary outcomes
Study Arms (2)
Low-Intensity (Usual Care)
ACTIVE COMPARATORPatient 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
High-Intensity
EXPERIMENTALPatient 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
Interventions
Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.
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.
Patients will receive reminders via SMS to take their blood pressure.
One-time training with action planning, access to website with language concordant patient education, and educational text messages
Educational text messages about behavioral changes that explicitly encourage seeking support from a support person
Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.
Patients will be asked to attend in-person or online group education classes on hypertension management
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- University of California, Daviscollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Agency for Healthcare Research and Quality (AHRQ)collaborator
Study Sites (1)
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (1)
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.
PMID: 41057081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Khoong, MD, MS
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 12, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share