[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693699":3,"trial-entities:NCT07693699":167,"trial-summary:NCT07693699":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":53,"secondary_outcomes":64,"sex":84,"minimum_age":85,"maximum_age":15,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":100,"locations":103,"central_contacts":156,"overall_officials":161,"references":165,"see_also_links":166},"NCT07693699","IRB00151173","Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care","Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial","RECRUITING","2026-11-20","2026-06","2026-08-03","2026-07-30","Wake Forest University Health Sciences","OTHER",null,"The goal of this study is to identify what cuff delivery and training strategies most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?","The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders\u002Fsupport, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.\n\nIn addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.\n\nPatients will be randomized to one of four arms:\n\n1. Mail-order cuff delivery with hands-on training\n2. Mail-order cuff delivery with written instructions\n3. In-clinic cuff distribution with hands-on training\n4. In-clinic cuff distribution with written instructions\n\nAll other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.",[19],"Hypertension",[21,22,23],"blood pressure cuff","blood pressure cuff delivery","blood pressure cuff instruction","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},150,"ESTIMATED",[32,38,43,48],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","In-Clinic Cuff Delivery - Hands-on Training","Complete vendor form; provide blood pressure log\u002Finstructions; demonstrate self-measured blood pressure using sample cuff; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.",[37],"In-clinic cuff distribution - Hands-on training",{"type":33,"name":39,"description":40,"armGroupLabels":41},"In-Clinic Cuff Delivery - Written Instructions","Complete vendor form; provide blood pressure log\u002Finstructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.",[42],"In-clinic cuff distribution - Written instructions",{"type":33,"name":44,"description":45,"armGroupLabels":46},"Mail Order Cuff Delivery - Hands-on Training","Complete vendor form; provide blood pressure log\u002Finstructions; demonstrate self-measured blood pressure using sample cuff; submit vendor form for mail delivery; complete envelope checklist.",[47],"Mail-order cuff delivery - Hands-on training",{"type":33,"name":49,"description":50,"armGroupLabels":51},"Mail Order Cuff Delivery - Written Instructions","Complete vendor form; provide blood pressure log\u002Finstructions; submit vendor form for mail delivery; complete envelope checklist.",[52],"Mail-order cuff delivery - Written instructions",[54,58,61],{"measure":55,"description":56,"timeFrame":57},"Rate of Blood Pressure Receipt","Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available","up to day 14",{"measure":59,"description":60,"timeFrame":57},"Rate of Training Completion","Number of participants that completed the assigned training modality as documented on the envelope checklist.",{"measure":62,"description":63,"timeFrame":57},"Rate of Cuff Order Completion","Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.",[65,68,72,75,78,81],{"measure":66,"description":67,"timeFrame":57},"Time to Complete Intervention","Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.",{"measure":69,"description":70,"timeFrame":71},"Number of Participants Documenting at Least One Blood Pressure Reading","Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.","up to day 21",{"measure":73,"description":74,"timeFrame":71},"Time Between Cuff Receipt and First Documented Reading","Number of days between cuff receipt and first documented self-monitored blood pressure reading.",{"measure":76,"description":77,"timeFrame":57},"Rate of Workflow Barriers","Number of participants with documented workflow barriers contributing to incomplete or non-concordant intervention delivery, including shipment issues, incomplete vendor forms, patient decline after workflow initiation, training not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.",{"measure":79,"description":80,"timeFrame":57},"Rate of Fidelity","Number of participants that received the assigned cuff delivery modality and assigned training modality without crossover, reassignment, or missing assigned workflow components.",{"measure":82,"description":83,"timeFrame":57},"Rate of Differential Implementation Success","Number of participants with successful delivery of both blood pressure cuff and training.","ALL","18 Years",false,{"inclusion":88,"exclusion":93,"raw_text":99},[89,90,91,92],"Age 18 years or older.","Diagnosed hypertension documented prior to the index clinic visit.","Scheduled for and attends an in-person visit with a participating clinician at a study clinic.","Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP \\>=140 mmHg or diastolic BP \\>=90 mmHg.",[94,95,96,97,98],"Visit is canceled, rescheduled, or the patient does not attend the visit.","Patient already has a usable home BP cuff provide through insurance within the past 5 years.","Patient declines assistance obtaining a BP cuff.","Patient declines submitting cuff order to insurance.","Patient unable to participate for operational reasons.","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosed hypertension documented prior to the index clinic visit.\n* Scheduled for and attends an in-person visit with a participating clinician at a study clinic.\n* Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP \\>=140 mmHg or diastolic BP \\>=90 mmHg.\n\nExclusion Criteria:\n\n* Visit is canceled, rescheduled, or the patient does not attend the visit.\n* Patient already has a usable home BP cuff provide through insurance within the past 5 years.\n* Patient declines assistance obtaining a BP cuff.\n* Patient declines submitting cuff order to insurance.\n* Patient unable to participate for operational reasons.",[101,102],"ADULT","OLDER_ADULT",[104,120,126,132,141,151],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":117},"Advocate Medical Group Chicago (Southeast)","NOT_YET_RECRUITING","Chicago","Illinois","60617","United States",[112],{"name":113,"role":114,"phone":115,"email":116},"Nicole Glowacki, MPH","CONTACT","708-684-3691","nicole.glowacki@aah.org",{"lat":118,"lon":119},41.85003,-87.65005,{"facility":121,"status":106,"city":107,"state":108,"zip":122,"country":110,"contacts":123,"geoPoint":125},"Advocate Medical Group Chicago (Imani Village)","60619",[124],{"name":113,"role":114,"phone":115,"email":116},{"lat":118,"lon":119},{"facility":127,"status":106,"city":107,"state":108,"zip":128,"country":110,"contacts":129,"geoPoint":131},"Advocate Medical Group Beverly","60643",[130],{"name":113,"role":114,"phone":115,"email":116},{"lat":118,"lon":119},{"facility":133,"status":106,"city":134,"state":108,"zip":135,"country":110,"contacts":136,"geoPoint":138},"Advocate Medical Group Merrionette Park","Merrionette Park","60803",[137],{"name":113,"role":114,"phone":115,"email":116},{"lat":139,"lon":140},41.6842,-87.70033,{"facility":142,"status":106,"city":143,"state":108,"zip":144,"country":110,"contacts":145,"geoPoint":148},"Advocate Medical Group Oak Lawn (FP)","Oak Lawn","60453",[146],{"name":113,"role":114,"phone":115,"email":147},"nicole.gowacki@aah.org",{"lat":149,"lon":150},41.71087,-87.75811,{"facility":152,"status":8,"city":143,"state":108,"zip":144,"country":110,"contacts":153,"geoPoint":155},"Advocate Medical Group Oak Lawn (IM)",[154],{"name":113,"role":114,"phone":115,"email":116},{"lat":149,"lon":150},[157],{"name":158,"role":114,"phone":159,"email":160},"Rasha Khatib, PhD","7086843691","Rasha.Alkhatib@aah.org",[162],{"name":158,"affiliation":163,"role":164},"Advocate Health","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":168,"biomarkers":169},[19],[],{"nct_id":4,"found":171,"summary":172,"prompt_version":182},true,{"design":173,"status":174,"heading":175,"summary":176,"follow_up":177,"word_count":178,"commitments":179,"compensation":180,"drugs_mentioned":181},"This is an interventional study planning to enroll 150 participants. Participants will be randomly assigned to one of four groups testing different ways to deliver blood pressure cuffs and training.","completed","Optimizing Cuff Access and Training for Self-Measured Blood Pressure Monitoring","This study is looking at the best ways to help adults with high blood pressure (hypertension) monitor their blood pressure at home. We want to find out the most effective methods for giving patients blood pressure cuffs and teaching them how to use them. The study compares four approaches: receiving a cuff in the clinic with hands-on training, receiving a cuff in the clinic with written instructions, getting a cuff by mail with hands-on training, or getting a cuff by mail with written instructions. We're hoping to learn which of these methods leads to more patients successfully getting a cuff and completing their training, ultimately helping them manage their blood pressure better.","The study will track your progress for up to 14 days to see if you received your blood pressure cuff and completed training.",112,"You would need to be 18 or older, have a diagnosis of high blood pressure, and attend an in-person clinic visit where your blood pressure is elevated. The study involves receiving a blood pressure cuff and instructions.","Not stated in the trial record.",[],"v2"]