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

Trial Summary

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 data supports the effectiveness of the COACH treatment for high blood pressure?

Research shows that involving health coaches, such as nonclinicians or students, can improve medication adherence and reduce blood pressure in patients with hypertension. Studies have found that health coaching interventions lead to better medication adherence and significant reductions in blood pressure, similar to those achieved with usual care. ^{1 2 3 4 5}

How is the COACH treatment for high blood pressure different from other treatments?

The COACH treatment is unique because it involves health coaching, where nonclinician personnel help patients manage their high blood pressure by focusing on medication adherence and lifestyle changes, giving patients a more active role in their care. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Richelle Koopman, MD

Principal Investigator

University of Missouri-Columbia

David Dorr, MD, MS, FACMI, FAMIA

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. [2021]

2. United States 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. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

The effects of lay counseling on medication adherence and blood pressure: adjunctive treatment for hypertension. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Delegating responsibility from clinicians to nonprofessional personnel: the example of hypertension control. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness research: evaluating pharmacist interventions and strategies to improve medication adherence. [2022]

6. New Zealand 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Closed-loop healthcare monitoring in a collaborative heart failure network. [2014]

9. Switzerland 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]. [2015]