200 Participants Needed

Health Coaching for Heart Disease

(HEALTHCOACH Trial)

DL
Overseen ByDaniel Luger, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are:* Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke?* Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes?* Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare?Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors.Participants will:* Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6.* Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare* Keep a log of their 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 focuses on health coaching and lifestyle changes, so it's best to discuss your medications with the trial team.

Is health coaching safe for humans?

Health coaching has been shown to be safe and well-received in various studies, with participants experiencing positive changes in behavior and health awareness. No significant safety concerns have been reported in the research available.12345

How is Longitudinal, Individualized Health Coaching different from other heart disease treatments?

Longitudinal, Individualized Health Coaching is unique because it focuses on personalized, ongoing support to help patients make lifestyle changes and improve adherence to medications, rather than just prescribing medication or procedures. This approach can lead to sustained improvements in heart health by addressing individual risk factors and encouraging proactive health management.16789

What data supports the effectiveness of the treatment Longitudinal, Individualized Health Coaching for heart disease?

Research shows that health coaching can help people manage chronic diseases by improving lifestyle habits like diet and exercise, which are important for heart health. A study found that health coaching led to better management of cardiovascular risk factors, suggesting it could be beneficial for heart disease.14101112

Who Is on the Research Team?

DL

Daniel Luger, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who are food insecure and at risk of heart disease, high cholesterol, hypertension, or diabetes. It's designed to help those who need lifestyle changes to improve their health. Participants will be screened for cardiovascular issues and must commit to virtual health coaching sessions.

Inclusion Criteria

Patient is a participant at a CHI sponsored, community screening event
Patient provides informed consent and willingness to participate for the duration of the study
At least 1 cardiometabolic risk factor at suboptimal level: Systolic BP greater than 130mmHg and/or diastolic BP greater than 80mmHg, Obesity: BMI greater than 30 kg/m^2, Dyslipidemia: Total cholesterol greater than 200 mg/dL, Triglycerides greater than 150 mg/dL, LDL greater than 130 mg/dL, HDL less than 40 mg/dL in men or less than 50 mg/dL in women, Hemoglobin A1c greater than or equal to 5.7%, 10-year ASCVD score greater than 5%, Access to a telehealth compatible device
See 1 more

Exclusion Criteria

All cardiometabolic risk factors at optimal levels
No telehealth compatible device
Pregnant patients
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Initial Health Coaching

Participants receive biweekly virtual health coaching sessions for lifestyle modification, including diet and exercise guidance.

4 weeks
4 sessions (virtual)

Continued Health Coaching

Participants continue with monthly virtual health coaching sessions to monitor and adjust lifestyle changes.

8 weeks
2 sessions (virtual)

Follow-up

Participants are monitored for changes in cardiometabolic risk factors and accessibility to healthcare.

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Longitudinal, Individualized Health Coaching
Trial Overview The study tests if regular virtual health coaching can lower the risk of heart attack or stroke over ten years, reduce blood pressure, cholesterol levels, and manage diabetes in a population that lacks access to sufficient food.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

The Physicians' Foundation

Collaborator

Published Research Related to This Trial

Patients referred to health coaching by their physician were much more likely to enroll (21.0% vs 6.0%) and complete the program (8.5% vs 2.7%) compared to those identified through insurer outreach, highlighting the importance of physician involvement in patient engagement.
Both groups showed significant improvements in health risk levels after health coaching, indicating that health coaching can effectively reduce health risks regardless of the referral source, but physician referrals greatly enhance participation.
Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness.Parkinson, MD., Hammonds, T., Keyser, DJ., et al.[2021]
In a study of Kaiser Permanente Northern California patients, 70% of those who completed two or more telephonic health coaching sessions reported satisfaction with the program, indicating a positive patient experience.
73% of participants who engaged in multiple sessions felt that the coaching helped them achieve their weight-related goals, highlighting the efficacy of telephonic coaching in promoting healthy lifestyle changes.
Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011.Adams, SR., Goler, NC., Sanna, RS., et al.[2021]
Health coaching delivered through videoconferencing (VC) resulted in significantly greater weight loss (8.23 kg) and increased physical activity (steps/day) compared to in-person coaching and a control group over a 12-week period, indicating its efficacy for adults with high BMI.
The VC group also showed a significant decrease in insulin resistance (HOMA-IR), suggesting that this method of health coaching can lead to improved metabolic health, while no significant changes were observed in glucose or HbA1c levels.
Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers.Johnson, KE., Alencar, MK., Coakley, KE., et al.[2023]

Citations

What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial. [2022]
Impact of Physician Referral to Health Coaching on Patient Engagement and Health Risks: An Observational Study of UPMC's Prescription for Wellness. [2021]
Improving awareness, accountability, and access through health coaching: qualitative study of patients' perspectives. [2018]
Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011. [2021]
Effects of health coaching on behavioral modification among adults with cardiovascular risk factors: Systematic review and meta-analysis. [2021]
Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. [2023]
Pilot Feasibility Study of Incorporating Whole Person Care Health Coaching Into an Employee Wellness Program. [2021]
Disease-specific perception of fracture risk and incident fracture rates: GLOW cohort study. [2022]
The COACH program produces sustained improvements in cardiovascular risk factors and adherence to recommended medications-two years follow-up. [2022]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
[Effects of Spouse-Participated Health Coaching for Male Office Workers with Cardiocerebrovascular Risk Factors]. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
How effective is health coaching in reducing health services expenditures? [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial. [2021]
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