Enhanced COACH CDS Tool for High Blood Pressure

(COACH Trial)

Recruiting at 2 trial locations

Overseen By Ashley Herrick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy, Cognitive impairment, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called COACH (Collaboration Oriented Approach to Controlling High Blood Pressure) to help people manage high blood pressure more effectively. The researchers aim to determine if COACH, which uses behavioral science to encourage self-management, can improve blood pressure outcomes compared to usual care. Participants will use an app to track their blood pressure and receive tailored messages and reminders. It suits those diagnosed with high blood pressure who use an online health portal to manage their health. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance self-management strategies for high blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your medications might interact with the study.

What prior data suggests that the COACH tool is safe for managing high blood pressure?

Research shows that the COACH tool, which helps manage high blood pressure, is generally safe for people. The COACH app is designed to help users track their blood pressure at home and improve their self-care habits. Studies examining the tool's effectiveness in blood pressure management have not identified any serious safety concerns or side effects from using the app.

This trial is labeled as "Not Applicable" for phase, indicating a focus on behavioral support rather than testing a new drug, so safety risks are minimal. The app provides reminders and visual aids to help manage blood pressure, which are non-invasive and usually very low risk.

In summary, based on current research, the COACH tool appears to be a safe option for those wanting to manage their high blood pressure more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for high blood pressure involve medications, lifestyle changes, or basic digital tools. But the Enhanced COACH is different because it leverages cognitive and behavioral science to help patients manage their blood pressure more effectively. This tool offers personalized features like visualizations of blood pressure trends, timely reminders, and emotionally tailored messages that encourage patients to set and achieve their health goals. Researchers are excited about this approach because it aims to empower individuals with a more engaging and supportive experience, potentially leading to better health outcomes than traditional methods.

What evidence suggests that the COACH tool is effective for managing high blood pressure?

This trial will compare two versions of the COACH app for managing high blood pressure. Research has shown that the COACH app can aid in managing high blood pressure by using behavioral science and technology to simplify tracking and control at home. Participants in the "Enhanced COACH" arm will receive personalized messages and reminders to encourage blood pressure management, potentially leading to better control. Previous studies have demonstrated that tools like COACH can boost patients' confidence and involvement in managing their health. By adding home blood pressure data to medical records, the app facilitates collaborative decision-making between patients and doctors. ^{1 2 3 4 6}

Who Is on the Research Team?

David Dorr, MD, MS, FACMI, FAMIA

Principal Investigator

Oregon Health and Science University

Richelle Koopman, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor recommends home blood pressure monitoring for me.

Patient receives care at a participating primary care clinic and has been seen in the last year

Patient is enrolled in online health portal

Exclusion Criteria

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

I have had bad reactions to blood pressure treatments, like dizziness or falls.

You are on hospice care or have a life expectancy of less than 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the COACH app for blood pressure management, integrating home blood pressure data and goals into EHR reporting

6 months

Regular virtual check-ins via the app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COACH

Trial Overview 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.

How Is the Trial Designed?

Group I: Enhanced COACH Experimental Treatment 1 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 COACH Active Control 1 Intervention

Equivalent of usual care delivered through the CDS tool: Blood pressure management with basic information, reduced reminders, and no affective alerts.

COACH is already approved in United States for the following indications:

Approved in United States as COACH for:

• Hypertension management

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

A health-coaching intervention significantly improved medication adherence among 477 patients with hypertension, leading to an increase in adherence scores from 5.75 to 5.94 (P = .04).

The intervention also resulted in a notable decrease in diastolic blood pressure from 81.6 to 76.1 mm Hg (P < .001), with improvements in medication adherence being linked to these reductions in blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a practice-based multicomponent intervention that includes health coaching on medication adherence and blood pressure control in rural primary care. Wu, JR., Cummings, DM., Li, Q., et al.[2021]

The HerzMobil Tirol network has developed a collaborative heart failure management concept that integrates mHealth-based telemonitoring with disease management programs to improve patient care and communication between patients and healthcare providers.

This approach aims to tailor the intensity of care based on the severity of the patient's condition and their risk of readmission, promoting continuity of care after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop healthcare monitoring in a collaborative heart failure network. Modre-Osprian, R., Pölzl, G., Von Der Heidt, A., et al.[2014]

The Health Coaching Program, tested by 20 family doctors over 12 months, successfully engaged 91% of invited patients, demonstrating high acceptance and feasibility among both patients and physicians.

Of the patients who participated, 37% completed all four steps of the program, and about 50% achieved a positive behavior change, indicating the program's effectiveness in promoting health behavior improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. Neuner-Jehle, S., Grüninger, U., Schmid, M.[2015]

Twenty participants with poorly controlled hypertension engaged in a three-month health coaching program led by pharmacists, resulting in positive health changes such as improved understanding and management of their condition.

Participants reported more realistic beliefs about hypertension and were generally positive about their coaching experiences, while pharmacists identified logistical challenges in implementing health coaching that could be addressed with better planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Australian Pharmacist Health Coaching Trial of Participants with Poorly Controlled Hypertension: A Qualitative Study of Participants' and Coaches' Experiences. Singh, HK., Kennedy, G., Stupans, I.[2022]

The Stroke Coach telehealth program did not significantly improve overall lifestyle behaviors among stroke survivors, as measured by the Health Promoting Lifestyle Profile II.

However, participants in the Stroke Coach group showed significant improvements in glucose control (HbA1c levels) and health-related quality of life (HRQoL) after 6 months, with these benefits maintained at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. Sakakibara, BM., Lear, SA., Barr, SI., et al.[2022]

Collaborative management between physicians and pharmacists has been shown to effectively lower blood pressure by enhancing medication adherence and optimizing treatment regimens.

The review highlights that while poor medication adherence contributes to inadequate blood pressure control, suboptimal medication regimens are often a more significant issue in primary care, suggesting a need for improved intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness research: evaluating pharmacist interventions and strategies to improve medication adherence. Carter, BL., Foppe van Mil, JW.[2022]

Clinicians are generally supportive of involving trained nonclinician health coaches in managing hypertension, believing that this delegation can improve medication adherence and patient outcomes.

The study highlights the importance of effective communication between coaches and clinicians, as well as the need for ongoing health coaching to maintain blood pressure control, especially in low-income patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delegating responsibility from clinicians to nonprofessional personnel: the example of hypertension control. Margolius, D., Wong, J., Goldman, ML., et al.[2012]

In a study involving 25 uninsured hypertensive patients, the use of trained student health coaches led to a significant increase in medication adherence and a notable reduction in systolic blood pressure by 11 mmHg.

Qualitative feedback indicated high patient satisfaction with the coaching intervention, suggesting that this model could be a feasible approach to improve blood pressure management in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. Leung, LB., Busch, AM., Nottage, SL., et al.[2021]

In a study of 10 noncompliant hypertensive patients, monitoring and counseling led to significant reductions in blood pressure, with systolic pressure decreasing by 10 mmHg and diastolic pressure by 7 mmHg (P < 0.05).

Counseling also improved medication adherence from 69% to 84%, demonstrating that adjunctive support can effectively enhance treatment outcomes for patients struggling with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. Hovell, MF., Geary, DC., Black, DR., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38977368/

Collaboration Oriented Approach to Controlling High blood ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management.

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/collaboration-oriented-approach-controlling-high-blood-pressure-coach

Collaboration-Oriented Approach to Controlling High Blood ... When applied to COACH, these four components will be: 1) a training module to improve patient confidence in monitoring their own BP; 2) weekly data ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/14/7/e085898

Study protocol: Collaboration Oriented Approach to ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06124716

Collaboration Oriented Approach to Controlling High Blood ... The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with ...

5. annfammed.org annfammed.org/content/21/Supplement_3/5452

Patient Co-Investigator Refinement of the Collaboration ... Patient Co-Investigator Refinement of the Collaboration Oriented Approach for Controlling High blood pressure (COACH) app. Richelle Koopman ...

6. researchgate.net researchgate.net/publication/382090014_Study_protocol_Collaboration_Oriented_Approach_to_Controlling_High_blood_pressure_COACH_in_adults_-_a_randomised_controlled_trial

Collaboration Oriented Approach to Controlling High blood ... This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management. Methods and analysis The study design ...