Health Coaching for Patients with Comorbidities

(Tipping Points Trial)

Not currently recruiting at 3 trial locations

Overseen By TJ Lin, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Directors Network

Disqualifiers: Metastatic cancer, End stage renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding health coaching to regular care helps individuals with multiple chronic health issues avoid hospital stays and disability. It compares two groups: one receiving standard care and another receiving care plus a health coach who assists with self-management and achieving personal goals. Individuals with multiple chronic conditions who are already patients at specific health centers in New York City and Chicago may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative approaches in managing chronic health conditions.

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 is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that health coaching is generally easy for patients to handle. Studies have found that health and wellness coaching can boost confidence, improve quality of life, and reduce depression in people with long-term health issues. This indicates that health coaching is both effective and safe for individuals with multiple health problems.

Further research has demonstrated that health coaching helps patients learn and gain skills, increasing their confidence in managing their health. This team-based approach encourages patients to take an active role in their care, which supports its safety.

These studies have reported no major safety issues, making health coaching a promising option for those with chronic health problems. Overall, current evidence suggests that health coaching is well-tolerated without significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Coach Intervention because it offers a fresh approach to managing multiple chronic diseases, focusing on the power of positive affect and self-affirmation. Unlike traditional treatments that mainly address symptoms, this method helps patients set and achieve life goals, encouraging them to take charge of their health. By integrating this motivational component with the usual care provided through the Patient-Centered Medical Home (PCMH), the intervention aims to enhance patient engagement and self-management, potentially leading to better overall health outcomes.

What evidence suggests that this trial's treatments could be effective for preventing unplanned hospitalization and increased disability?

Research shows that health coaching can assist people with long-term health issues. In this trial, one group will receive a health coaching intervention alongside the usual care provided by the Patient-Centered Medical Home (PCMH). Studies have found that these coaching programs boost confidence in managing health, improve quality of life, and reduce feelings of depression for those with chronic illnesses. Additionally, health coaching benefits older adults with multiple health problems. Adding health coaching to care plans can help prevent unexpected hospital visits and better manage disabilities. ^{2 3 6 7 8}

Who Is on the Research Team?

Jonathan N Tobin, PhD

Principal Investigator

Clinical Directors Network

Mary Charlson, MD

Principal Investigator

Weill Medical College of Cornell University

Andrea Cassells, MPH

Principal Investigator

Clinical Directors Network

Anisa Mian, MPH

Principal Investigator

Clinical Directors Network

Are You a Good Fit for This Trial?

This trial is for adult patients with multiple chronic diseases (comorbidity index ≥4) who are already receiving care at certain health centers in NYC and Chicago. It's not open to those with metastatic cancer, end-stage renal disease on dialysis, severe mental illness, language barriers (non-English/Spanish speakers), post-transplant status, or drug/alcohol abuse issues.

Inclusion Criteria

You have multiple serious health conditions with a score of 4 or higher on the Charlson Comorbidity Index.

Established patients of the participating Federally Qualified Health Centers (FHQCs)

Exclusion Criteria

You have a history of drug or alcohol abuse.

My cancer has spread to other parts of my body.

I am on dialysis for end-stage kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Patient Centered Medical Home (PCMH) care or PCMH plus a health coaching intervention

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Coach Intervention

Trial Overview The study tests if adding a health coaching intervention to the standard Patient Centered Medical Home care can prevent serious health declines leading to hospital stays and disability in high-risk patients. Participants will be grouped by their healthcare center location and randomly assigned one of the two approaches.

How Is the Trial Designed?

Group I: Patient Centered Medical Home (PCMH) plus Health Coach Experimental Treatment 1 Intervention

A health coaching intervention that employs a positive affect/self-affirmation intervention to help motivate patients to succeed at implementing self-management by setting life goals, in addition to the usual care provided for patients with multiple chronic diseases by the The Patient-Centered Medical Home (PCMH).

Group II: Patient Centered Medical Home (PCMH) Active Control 1 Intervention

Usual care provided for patients with multiple chronic diseases by the Patient-Centered Medical Home (PCMH).

Who Is Running the Clinical Trial?

Clinical Directors Network

Lead Sponsor

Trials

13

Recruited

14,200+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.

If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]

This systematic review and meta-analysis aims to evaluate the effectiveness of health coaching in improving health outcomes for individuals with chronic conditions, focusing on clinically important and disease-specific outcomes.

The study will analyze how different components of health coaching, such as the type of coach (health professional vs. trained peer), frequency, and setting, influence its effectiveness, providing valuable insights for optimizing health coaching interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching interventions for persons with chronic conditions: a systematic review and meta-analysis protocol. Boehmer, KR., Barakat, S., Ahn, S., et al.[2019]

This review analyzed five studies on life coaching interventions in healthcare, finding that while the evidence is limited, some patients, particularly those who typically do not respond well to standard interventions, showed promising improvements in health outcomes like HbA1c levels.

The studies suggest that life coaching may enhance self-efficacy and self-empowerment, indicating that alternative communication and approaches in patient care can lead to better engagement and outcomes for disadvantaged patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can life coaching improve health outcomes?--A systematic review of intervention studies. Ammentorp, J., Uhrenfeldt, L., Angel, F., et al.[2022]

Health coaching significantly improved various health outcomes, including stress levels, healthy eating, exercise, and overall quality of life, with 89% of participants achieving at least one health goal within 6 months.

Despite only 7% of eligible candidates participating, those with higher chronic disease burdens were more likely to engage, indicating that health coaching may be particularly beneficial for individuals with complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of Telephonic Health Coaching on Health Outcomes in a High-risk Population. Lawson, KL., Jonk, Y., O'Connor, H., et al.[2022]

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]

A 12-week health coaching program involving 82 participants led to significant weight loss and improvements in diet and physical activity, even though weight loss was not the primary goal of the study.

Medical assistants can effectively be trained to provide health coaching, and both patients and providers reported high satisfaction with the program, suggesting it could be beneficial in family medicine clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Health Coaching by Medical Assistants in Primary Care. Djuric, Z., Segar, M., Orizondo, C., et al.[2022]

Health and wellness coaching (HWC) is emerging as an effective method for promoting lifestyle changes to prevent and treat chronic diseases like diabetes and heart disease, based on a systematic review of 219 articles, 150 of which were data-based.

The review highlights the need for further research to establish consensus on HWC definitions and standards, as the current literature is scattered and lacks a comprehensive summary, making it challenging for practitioners and researchers to access relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compendium of the Health and Wellness Coaching Literature. Sforzo, GA., Kaye, MP., Todorova, I., et al.[2020]

The comprehensive lifestyle health coaching (LHC) program has been successfully implemented in various settings, including large employers and healthcare facilities, using technology to deliver services primarily via telephone and the Internet.

Outcomes from published studies and clinical trials demonstrate that the LHC program effectively modifies multiple health risk factors in both healthy individuals and those with chronic diseases, showcasing its clinical effectiveness and integration with traditional medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. Gordon, NF., Salmon, RD., Wright, BS., et al.[2020]

Patient coaching is an effective process that helps individuals achieve their health goals, whether for preventive measures or chronic treatment.

By creating a supportive environment for open communication, coaching can lead to quicker and more efficient improvements in health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Coaching and diabetes]. Roca, JM.[2011]

Health coaching significantly reduced outpatient and total healthcare expenditures for high-risk participants, with estimated savings of $286 and $412 per person per month, respectively.

While health coaching did not impact emergency room costs, it did lead to a significant decrease in the probability of incurring inpatient expenditures, highlighting its potential effectiveness in managing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is health coaching in reducing health services expenditures? Jonk, Y., Lawson, K., O'Connor, H., et al.[2022]

In a study involving 4377 older adults with multimorbidity, health coaching did not show significant improvements in patient-reported outcomes like quality of life or depression, likely due to low uptake of the intervention (41% consent rate).

Despite the lack of improvement in primary outcomes, health coaching was associated with lower emergency care use and a potential cost-effectiveness with an incremental cost per quality-adjusted life year (QALY) of £8049, suggesting it may still be a valuable approach for managing multimorbidity in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is telephone health coaching a useful population health strategy for supporting older people with multimorbidity? An evaluation of reach, effectiveness and cost-effectiveness using a 'trial within a cohort'. Panagioti, M., Reeves, D., Meacock, R., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The My Health, My Life, My Way study is a 6-month randomized controlled trial involving 200 individuals with chronic conditions and physical disabilities, designed to assess the feasibility and preliminary efficacy of a web-based self-management program that combines health coaching and telehealth technology.

The study aims to determine the most effective combination of scheduled coaching calls and gamified rewards to enhance participation in self-management, potentially leading to a scalable solution for managing chronic conditions in people with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study. Evans, E., Zengul, A., Knight, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125027/

Clinical Effectiveness of Lifestyle Health Coaching In this article, we describe the key features of an affordable, evidence-based, technology-enabled, data-driven, outcomes-oriented, comprehensive lifestyle ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399123003555

The impact of health and wellness coaching on patient ... Health and Wellness Coaching (HWC) improved short-term self-efficacy, quality of life, and depression for patients with chronic conditions.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0197457225003520

Effectiveness of a digital health coaching self-management ... This study will demonstrate that digital health coaching interventions are feasible and effective among older adults with multimorbidity and limited ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0236734

Health and wellness coaching positively impacts individuals ... Health and wellness coaching (HWC) interventions have been reported to improve health outcomes for individuals with chronic diseases such as ...

5. neurologylive.com neurologylive.com/view/reviewing-power-health-wellness-coaching-ms-care

Reviewing the Power of Health and Wellness Coaching in ... They found that health and wellness coaching improved short-term self-efficacy, quality of life, and depression for patients with chronic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964774/

The impact of health and wellness coaching on patient ... Health and Wellness Coaching (HWC) may be beneficial in chronic condition care. We sought to appraise its effectiveness on quality of life (QoL), self-efficacy ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08649-x

Lay health coaching intervention for older adults with chronic ... Health coaching is a promising intervention that enhances individuals' health knowledge and supports changes in health behaviours. Even though ...

8. edhub.ama-assn.org edhub.ama-assn.org/steps-forward/module/2827438

Health Coaching: Help Patients Take Charge of Their Health Health coaching is a team-based approach that helps patients gain the knowledge, skills, and confidence to become active participants in their care.