Trials / Enrolling By Invitation
Enrolling By InvitationNCT06871462
Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | 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 | 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 | 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. |
| BEHAVIORAL | Group classes | Patients will be asked to attend in-person or online group education classes on hypertension management |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2027-11-01
- Completion
- 2028-05-01
- First posted
- 2025-03-12
- Last updated
- 2026-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06871462. Inclusion in this directory is not an endorsement.