Blood Pressure Monitoring, HomeINSPIREDNCT06871462
Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
A study testing BP monitor use training and app training, Online patient portal enrollment and training and SMS reminders to take blood pressure in people with Blood Pressure Monitoring, Home and Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure Monitoring, Home, Hypertension
- What is being tested?
- BP monitor use training and app training, Online patient portal enrollment and training and SMS reminders to take blood pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
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.
Read the 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.
- Conditions
- Blood Pressure Monitoring, Home, Hypertension
- Being tested
- BP monitor use training and app training, Online patient portal enrollment and training, SMS reminders to take blood pressure, Education about self-management of hypertension, Educational text messages that encourage seeking support from a support person
- Keywords
- INSPIRED
- Medical subject headings
- Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP monitor use training and app trainingBehavioural
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 trainingBehavioural
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 pressureBehavioural
Patients will receive reminders via SMS to take their blood pressure.
Education about self-management of hypertensionBehavioural
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 personBehavioural
Educational text messages about behavioral changes that explicitly encourage seeking support from a support person
Involvement of caregiver or support personBehavioural
Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.
Group classesBehavioural
Patients will be asked to attend in-person or online group education classes on hypertension management
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity (Usual Care) | Active comparator | 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 Receives: Behavioral: BP monitor use training and app training; Behavioral: Online patient portal enrollment and training; Behavioral: SMS reminders to take blood pressure; Behavioral: Education about self-management of hypertension |
| High-Intensity | Experimental | 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 Receives: Behavioral: BP monitor use training and app training; Behavioral: Online patient portal enrollment and 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: Involvement of caregiver or support person; Behavioral: Group classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinic systolic BP
Measured: Baseline, 12 months, 18 months
BP Control
Clinic patients with EHR recorded BP < 140/90
Measured: Monthly (-6 to 18 months)
Secondary outcomes (7)
BP Control
Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values
Measured: Baseline, 12 months, 18 months
Home Systolic BP (SBP)
Home SBP for enrolled participants
Measured: Baseline, 12 months, 18 months
Patient Adoption
Number of SMBP values per participant
Measured: 12 months
Clinic adoption
Clinic patients with EHR documented patient reported BP
Measured: Monthly (-6 to 18 months)
Reach
Percent of participants who actively participate in SMBP monitoring
Measured: 12 months
Costs
Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies
Measured: During trial; 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).
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 May 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure Monitoring, HomeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Beth Israel Deaconess Medical Center, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Elaine Khoong, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871462
- Sponsor's protocol ID
- 24-42092
- Other IDs
- R18HS029817
- Acronym
- INSPIRED
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41057081