Collaboration Oriented Approach to Controlling High Blood Pressure
Hypertension is a significant contributor to poor cardiovascular outcomes. Self-management support tools can increase patient behaviors to improve blood pressure. The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with communications informed by behavioral economics principles to support shared decision-making. The study aims to measure the effectiveness of the COACH intervention in a pragmatic multi-site randomized trial in a primary care setting.
Conditions:
🦠 Hypertension 🦠 Multiple Chronic Conditions
🗓️ Study Start (Actual) 12 January 2024
🗓️ Primary Completion (Estimated) 31 May 2026
✅ Study Completion (Estimated) 30 June 2026
👥 Enrollment (Estimated) 550
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbia, Missouri, United States
📍 Portland, Oregon, United States
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adult patients aged 18-100 years old
    • * Patient receives care at a participating primary care clinic and has been seen in the last year
    • * Patient has high BP, defined as an average of 4 BPs \> 140 systolic or \> 90 diastolic (clinic) or \> 135 OR \> 85 (home)
    • * Patient is enrolled in online health portal
    • * Patient can communicate in English
    • * Patient has been recommended by their physician who thinks the patient would benefit from a home blood pressure monitoring program.

    Exclusion Criteria:

    • * Patient is pregnant at the time of consent
    • * Patient who, in the opinion of the primary care clinician, has severe cognitive impairment
    • * Patient is on hospice care and/or has a life expectancy of less than 2 years
    • * Patient has end stage renal disease
    • * Patient for whom tight blood pressure control presents a greater risk, such as those with a history of adverse events from hypertension treatment (falls, dizziness, electrolyte disturbances, hypotension, active heart failure)
    • * Patient has any other disease or disorder that in the opinion of the investigator or the patient's primary care clinician, could put participants at risk and affect trial results, or hinder participation will exclude them from participating
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 November 2023
  • First Submitted that Met QC Criteria 6 November 2023
  • First Posted 9 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 March 2024
  • Last Update Posted 25 March 2024
  • Last Verified March 2024