[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06871462":3,"trial-entities:NCT06871462":141,"trial-summary:NCT06871462":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":61,"secondary_outcomes":69,"sex":93,"minimum_age":94,"maximum_age":95,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":117,"locations":120,"central_contacts":130,"overall_officials":131,"references":135,"see_also_links":140},"NCT06871462","24-42092","Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations","ENROLLING_BY_INVITATION","2028-05-01","2026-02","2026-02-05","2025-05-01","University of California, San Francisco","OTHER",true,"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.","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.",[18,19],"Blood Pressure Monitoring, Home","Hypertension",[21],"INSPIRED","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},330,"ESTIMATED",[30,37,41,45,49,53,57],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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.",[35,36],"High-Intensity","Low-Intensity (Usual Care)",{"type":31,"name":38,"description":39,"armGroupLabels":40},"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.",[35,36],{"type":31,"name":42,"description":43,"armGroupLabels":44},"SMS reminders to take blood pressure","Patients will receive reminders via SMS to take their blood pressure.",[35,36],{"type":31,"name":46,"description":47,"armGroupLabels":48},"Education about self-management of hypertension","One-time training with action planning, access to website with language concordant patient education, and educational text messages",[35,36],{"type":31,"name":50,"description":51,"armGroupLabels":52},"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",[35],{"type":31,"name":54,"description":55,"armGroupLabels":56},"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.",[35],{"type":31,"name":58,"description":59,"armGroupLabels":60},"Group classes","Patients will be asked to attend in-person or online group education classes on hypertension management",[35],[62,65],{"measure":63,"timeFrame":64},"Change in clinic systolic BP","Baseline, 12 months, 18 months",{"measure":66,"description":67,"timeFrame":68},"BP Control","Clinic patients with EHR recorded BP \\\u003C 140\u002F90","Monthly (-6 to 18 months)",[70,72,75,79,82,85,89],{"measure":66,"description":71,"timeFrame":64},"Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values",{"measure":73,"description":74,"timeFrame":64},"Home Systolic BP (SBP)","Home SBP for enrolled participants",{"measure":76,"description":77,"timeFrame":78},"Patient Adoption","Number of SMBP values per participant","12 months",{"measure":80,"description":81,"timeFrame":68},"Clinic adoption","Clinic patients with EHR documented patient reported BP",{"measure":83,"description":84,"timeFrame":78},"Reach","Percent of participants who actively participate in SMBP monitoring",{"measure":86,"description":87,"timeFrame":88},"Costs","Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies","During trial; 12 months",{"measure":90,"description":91,"timeFrame":92},"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","ALL","18 Years",null,false,{"inclusion":98,"exclusion":107,"raw_text":116},[99,100,101,102,103,104,105,106],"18 years old\u002Forder","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\u002F90 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",[108,109,110,111,112,113,114,115],"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","Inclusion Criteria:\n\n* 18 years old\u002Forder\n* Any sex or gender\n* Any race or ethnicity\n* Must be receiving primary care at any of the six enrolled clinics\n* Have uncontrolled hypertension (BP \\>=140\u002F90 mmHg at any two encounters in the previous 18 months, including the most recent encounter prior to enrollment)\n* Can read and write English, Spanish, or Cantonese\n* Be able to provide consent\n* Must own a cell phone that receives SMS or text messages\n\nExclusion Criteria:\n\n* Those with conditions that might complicate remote BP monitoring:\n\n  * Pregnancy (and 12 months postpartum)\n  * Acute myocardial infarction or stroke in the last 12 months\n  * End-stage renal disease on dialysis\n  * Stage D heart failure\n  * Active treatment for cancer (except for nonmelanoma skin cancers)\n  * Pacemaker use\n* Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation",[118,119],"ADULT","OLDER_ADULT",[121],{"facility":122,"city":123,"state":124,"zip":125,"country":126,"geoPoint":127},"Zuckerberg San Francisco General Hospital","San Francisco","California","94110","United States",{"lat":128,"lon":129},37.77493,-122.41942,[],[132],{"name":133,"affiliation":12,"role":134},"Elaine Khoong, MD, MS","PRINCIPAL_INVESTIGATOR",[136],{"pmid":137,"type":138,"citation":139},"41057081","DERIVED","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\u002Fj.cct.2025.108101. Epub 2025 Oct 6.",[],{"nct_id":4,"conditions":142,"biomarkers":143},[19],[],{"nct_id":4,"found":96,"summary":95,"prompt_version":95}]