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Behavioural Intervention
Enhanced COACH CDS Tool for High Blood Pressure (COACH Trial)
N/A
Recruiting
Led By David Dorr, MD, MS, FACMI, FAMIA
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients aged 18-100 years old
Be older than 18 years old
Must not have
Patient has end stage renal disease
Patient has secondary hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a clinical app (COACH) to help people with hypertension manage their blood pressure, ultimately improving their heart health.
Who is the study for?
This trial is for adults aged 18-100 with high blood pressure, who are patients at a participating clinic and use an online health portal. They must have had multiple recent high BP readings and be recommended by their doctor for home monitoring. Exclusions include pregnancy, secondary hypertension, severe cognitive impairment, life expectancy under 2 years, end stage renal disease or risks from tight BP control.
What is being tested?
The study tests the COACH app's effectiveness in managing blood pressure within primary care settings. Participants will either use the Enhanced COACH CDS Tool designed to integrate home BP data into electronic health records or receive Usual Care with standard support tools.
What are the potential side effects?
Since this trial involves using a decision support tool rather than medication, traditional side effects are not expected. However, participants may experience stress or anxiety related to self-monitoring and potential technical issues with the app.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 100 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidneys are in the final stage of failure.
Select...
I have high blood pressure caused by another health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Pressure Control
Secondary study objectives
COACH Application System Usability Evaluation
Demographic factors contributing to blood pressure control
Participant report of health behaviors including Self Efficacy, Social Support, Outcome Expectations and Self-regulation
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced COACHExperimental Treatment1 Intervention
Enhanced blood pressure management recommendations that use cognitive and behavioral science to increase the likelihood of self-management goal setting to lower blood pressure. The CDS tool allows participant access to BP visualizations, reminders, and affectively tailored messaging about blood pressure management.
Group II: Usual Care COACHActive Control1 Intervention
Equivalent of usual care delivered through the CDS tool: Blood pressure management with basic information, reduced reminders, and no affective alerts.
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Who is running the clinical trial?
University of Missouri-ColumbiaOTHER
378 Previous Clinical Trials
627,932 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
901 Previous Clinical Trials
939,076 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,422 Total Patients Enrolled
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