RECRUITING

Collaboration Oriented Approach to Controlling High Blood Pressure

Conditions

Hypertension Multiple Chronic Conditions Pragmatic trial Primary care Clinical decision support

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Collaboration Oriented Approach to Controlling High Blood Pressure

Quick Facts

Study Start:2024-01-12

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06124716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

LeAnn Michaels

CONTACT

5034944806

michaell@ohsu.edu

Aisha Ghumman

CONTACT

ghumman@ohsu.edu

Principal Investigator

David Dorr, MD, MS, FACMI, FAMIA

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Richelle Koopman, MD

PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Study Locations (Sites)

University of Missouri-Columbia

Columbia, Missouri, 65211

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

David Dorr, MD, MS, FACMI, FAMIA, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University
Richelle Koopman, MD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

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

Study Start Date2024-01-12

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-01-12

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Pragmatic trial
Primary care
Clinical decision support

Additional Relevant MeSH Terms

Hypertension
Multiple Chronic Conditions