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Enrolling by Invitation

NCT Number: NCT06871462

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BP monitor use training and app training

Behavioral

Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.

Online patient portal enrollment and training

Behavioral

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.

SMS reminders to take blood pressure

Behavioral

Patients will receive reminders via SMS to take their blood pressure.

Education about self-management of hypertension

Behavioral

One-time training with action planning, access to website with language concordant patient education, and educational text messages

Educational text messages that encourage seeking support from a support person

Behavioral

Educational text messages about behavioral changes that explicitly encourage seeking support from a support person

Involvement of caregiver or support person

Behavioral

Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.

Group classes

Behavioral

Patients will be asked to attend in-person or online group education classes on hypertension management

Primary outcomes

  1. Change in clinic systolic BP

    Time frame: Baseline, 12 months, 18 months

  2. BP Control

    Time frame: Monthly (-6 to 18 months)

    Clinic patients with EHR recorded BP < 140/90

Secondary outcomes

  1. BP Control

    Time frame: Baseline, 12 months, 18 months

    Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values

  2. Home Systolic BP (SBP)

    Time frame: Baseline, 12 months, 18 months

    Home SBP for enrolled participants

  3. Patient Adoption

    Time frame: 12 months

    Number of SMBP values per participant

  4. Clinic adoption

    Time frame: Monthly (-6 to 18 months)

    Clinic patients with EHR documented patient reported BP

  5. Reach

    Time frame: 12 months

    Percent of participants who actively participate in SMBP monitoring

  6. Costs

    Time frame: During trial; 12 months

    Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies

  7. Patient Activation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Beth Israel Deaconess Medical Center
  • University of California, Davis

Registry information

Acronym: INSPIRED

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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