Health Coach Consultations for Asthma-COPD Overlap Syndrome

(PuSHCon Trial)

No longer recruiting at 10 trial locations

Overseen By Abby Cabrera, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pulmonary care, Cognitive dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how health coaches can assist individuals with poorly controlled asthma or COPD (a lung disease that makes breathing difficult) by connecting them with specialists. The aim is to determine if a health coach helps patients follow specialist advice more effectively than standard care. Participants will either work with a health coach (PushCon Model) or continue with their usual care. Suitable candidates speak English or Spanish, have asthma or COPD, and struggle with managing their symptoms. As an unphased trial, this study offers a unique opportunity to explore innovative care strategies that could enhance health management.

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 seems to focus on health coaching rather than medication changes.

What prior data suggests that the PuSHCon model is safe for patients with asthma-COPD overlap syndrome?

Research has shown that using health coaches for asthma and COPD care is promising. Studies indicate that this method, known as the PuSHCon model, helps patients follow their doctor's advice more effectively without requiring additional in-person visits.

In this treatment, a health coach collaborates with a lung specialist to provide advice and support to patients. This approach has been implemented without reports of serious side effects. The main goal is to enhance patients' quality of life and simplify the management of their conditions.

Overall, the PuSHCon model is considered safe and has been well-received in previous applications, making it a potentially beneficial option for patients seeking improved asthma and COPD management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PushCon model for managing asthma-COPD overlap syndrome because it integrates personalized health coaching with specialist support. Unlike the usual care, which typically involves standard management by primary care clinicians, this model provides patients with a health coach who collaborates with a pulmonary specialist to tailor recommendations. This approach aims to enhance patient outcomes by ensuring that primary care clinicians receive expert guidance and support throughout the treatment process, potentially leading to more precise and effective management of the condition.

What evidence suggests that the PuSHCon model is effective for asthma-COPD overlap syndrome?

Research has shown that the PuSHCon model, a treatment arm in this trial that includes support from health coaches, can improve health for individuals with asthma, COPD, and asthma-COPD overlap syndrome. Studies have found that health coaches help patients follow their doctor's advice more effectively, reducing the need for frequent in-person visits. This approach has successfully managed symptoms and decreased hospital visits. Patients have reported easier access to specialist care, aiding in better condition management. Overall, the PuSHCon model appears promising in enhancing care for individuals with these respiratory issues. ^{3 4 5 6 7}

Who Is on the Research Team?

Rachel Willard-Grace, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with asthma or COPD who have uncontrolled symptoms or frequent flare-ups. Participants must speak English or Spanish and plan to visit their primary care clinic within the next 3 months. It's not for those already receiving specialist lung care, without a phone, or with cognitive issues preventing them from working with a health coach.

Inclusion Criteria

My symptoms are not under control.

I have been diagnosed with asthma or COPD.

Exclusion Criteria

I do not have a phone for contact.

You have seen a lung specialist at least once in the past year.

I can communicate and interact with a health coach without issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health coaching or usual care for COPD and asthma management

16 weeks

Regular follow-ups with health coach or primary care clinician

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PushCon Model
• Usual care

Trial Overview The study is testing the PuSHCon model where patients get help from health coaches alongside usual care versus just getting usual care. The goal is to see if this extra support improves access to specialist advice and its implementation in treatment plans for low-income patients at public clinics.

How Is the Trial Designed?

Group I: PuSHCon model Experimental Treatment 1 Intervention

A health coach will contact patients with poorly controlled asthma or COPD. The health coach will gather information from the patient and medical record and review the case with a pulmonary specialist. The specialist will provide recommendations to the primary care clinician based on the case review; the specialist may request an in-person patient visit if needed. The health coach will follow up with the primary care clinician and will support implementation of recommendations that the the primary care clinician accepts,

Group II: Usual care Active Control 1 Intervention

Patients with poorly controlled asthma or COPD will receive the standard of care, which usually means management within primary care. The study team will provide in-service sessions on COPD and asthma guidelines to primary care clinicians in both arms. As in standard practice, a primary care clinician may refer a patient for specialty consultation or diagnostic testing at any time.

PushCon Model is already approved in United States for the following indications:

Approved in United States as PuSHCon Model for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma
• Asthma COPD Overlap Syndrome (ACOS)

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 100 cancer patients experiencing chemotherapy-induced peripheral neuropathy (CIPN), 81% reported a fear of falling during daily activities, indicating a significant impact on their self-efficacy related to fall prevention.

Low perceived self-efficacy in preventing falls was notably associated with being female, having a low body mass index (BMI), and higher severity of CIPN symptoms, suggesting that these factors may increase the need for targeted interventions to improve fall-related confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Fall-Related Self-Efficacy: Characteristics that Influence the Perception of Patients with Chemotherapy-Induced Peripheral Neuropathy. Yamamoto, S., Fujikawa, N., Asano, K., et al.[2022]

Chronic obstructive pulmonary disease (COPD) is a serious condition primarily caused by smoking, and its management includes addressing exacerbations and comorbidities, which can significantly affect patients' quality of life and prognosis.

Regular physical activity and pulmonary rehabilitation are crucial for all COPD patients, as they can improve symptoms, enhance health-related quality of life, and reduce hospitalization rates, highlighting the importance of exercise in managing this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent updates in chronic obstructive pulmonary disease. Garvey, C.[2016]

Long-acting bronchodilators, such as tiotropium, have been shown to reduce exacerbation rates and improve health-related quality of life in COPD patients, based on findings from the UPLIFT® and TORCH trials involving large patient populations.

Despite the primary outcomes of lung function decline and mortality being negative, the use of tiotropium and combination therapies did not increase mortality risk or serious cardiac events, indicating a favorable safety profile for these maintenance treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease megatrials: taking the results into office practice. Stoloff, SW.[2015]

Early supportive care interventions in cancer treatment significantly improve symptoms, quality of life, and overall survival, highlighting the importance of regular assessment of patient needs using validated tools.

Nonpharmacologic strategies, such as physical exercise, counseling, and cognitive behavioral therapy, are effective in managing common issues like cancer-related fatigue and malnutrition, while pharmacologic agents have limited efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care: Low Cost, High Value. Popescu, RA., Roila, F., Arends, J., et al.[2021]

Health coaching significantly improves health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD), with a standardized mean difference of -0.69 based on a meta-analysis of 10 randomized controlled trials involving various health coaching components.

The intervention also leads to a notable reduction in COPD-related hospital admissions, with an odds ratio of 0.46, indicating that health coaching can help manage COPD more effectively and potentially lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does health coaching improve health-related quality of life and reduce hospital admissions in people with chronic obstructive pulmonary disease? A systematic review and meta-analysis. Long, H., Howells, K., Peters, S., et al.[2019]

Out-of-hospital coaching by specialized respiratory nurses for 170 severe COPD patients led to a 24% reduction in hospitalization rates and improvements in health status, anxiety, and nutritional status over a 6-month period.

The coaching program was well-accepted by patients and successfully implemented, highlighting its feasibility and effectiveness in enhancing health management and reducing healthcare costs associated with re-hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive out-of-hospital coaching for frequently hospitalized COPD patients: a before-after feasibility study. Noort, BAC., van der Vaart, T., van der Maten, J., et al.[2023]

In a study of 296 long-term breast cancer survivors who received taxane-based chemotherapy, 58.4% reported symptoms of chemotherapy-induced peripheral neuropathy (CIPN), with obesity identified as a significant risk factor for developing these symptoms.

Survivors with CIPN experienced higher levels of psychological distress, including anxiety and depression, and had increased rates of falls, highlighting the need for targeted interventions that address both CIPN and associated mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors: prevalence, risk factors, and fall risk. Bao, T., Basal, C., Seluzicki, C., et al.[2022]

Cancer survivors expressed a willingness to try virtual yoga as a nonpharmacological treatment for chronic chemotherapy-induced peripheral neuropathy pain, highlighting the need for alternative therapies due to the ineffectiveness of medications.

Participants appreciated the flexibility of virtual yoga sessions but noted a desire for the social support that in-person classes provide, indicating that while virtual formats are convenient, they may lack important social interaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic. Knoerl, R., Bockhoff, J., Fox, E., et al.[2023]

An online self-help intervention called 'Embrace Pain' was developed using Acceptance and Commitment Therapy (ACT) to help cancer survivors manage chemotherapy-induced peripheral neuropathy (CIPN), which affects about 30% of survivors long after treatment.

The intervention was shaped by patient feedback and expert insights, ensuring it is user-friendly and addresses the specific needs of survivors, featuring six sessions focused on psychoeducation and ACT processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered development of Embrace Pain: an online acceptance and commitment therapy intervention for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy. van de Graaf, DL., Smeets, T., van der Lee, ML., et al.[2023]

A nurse-led multidisciplinary program for pulmonary rehabilitation significantly reduced the frequency of exacerbations in patients with chronic obstructive pulmonary disease (COPD), with a notable difference between the intervention group and the control group after one year (p=0.009).

However, the program did not result in significant improvements in functional capacity or quality of life, indicating that while it may help manage exacerbations, further research is needed to assess its impact on overall health and daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led multidisciplinary programme for patients with COPD in primary health care: a controlled trial. Zakrisson, AB., Engfeldt, P., Hägglund, D., et al.[2021]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT03695276

Pulmonary Specialist-Health Coach Consult Model Study The proposed study will evaluate the effectiveness of a novel model for pulmonary specialist-health coach consultations (PuSHCon) in its ability ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S155372502100194X

Implementation and Impact of the Pulmonary Specialist ... In this novel model, health coaches facilitated pulmonary specialist consultations for patients with COPD without the need for an in-person visit.

3. withpower.com withpower.com/trial/phase-asthma-9-2020-e11c4

Health Coach Consultations for Asthma-COPD Overlap ... This trial tests a new approach where health coaches assist low-income patients with COPD, asthma, or ACOS in following their doctor's advice.

4. cepc.ucsf.edu cepc.ucsf.edu/sites/cepc.ucsf.edu/files/PuSHCon%20Health%20Coach%20Consultation%20Template%202019-1218_0.pdf

Health Coach Consultation Form for Patients with Chronic ... This form is designed to guide staff in gathering information from patients with chronic obstructive pulmonary disease (COPD) and/or Asthma in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28223792/

Asthma-COPD overlap syndrome in the US - PubMed - NIH Asthma-COPD overlap syndrome in the US: a prospective population-based analysis of patient-reported outcomes and health care utilization.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03695276

Pulmonary Specialist-Health Coach Consult Model Study The second aim of the study regarding patient-reported outcomes will be measured primarily through the change in COPD and/or asthma related quality of life ...

7. trialx.com trialx.com/clinical-trials/listings/222331/pulmonary-specialist-health-coach-consult-model-study/

Pulmonary Specialist-Health Coach Consult Model Study The proposed study will evaluate the effectiveness of a novel model for pulmonary specialist-health coach consultations (PuSHCon) in its ability ...