Health Coach Consultations for Asthma-COPD Overlap Syndrome

(PuSHCon Trial)

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

360 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new approach where health coaches assist low-income patients with COPD, asthma, or ACOS in following their doctor's advice. The goal is to improve their care and health by ensuring they understand and adhere to specialist recommendations.

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 data supports the effectiveness of the treatment PushCon Model, Pulmonary Specialist-Health Coach Consultation Model, PuSHCon Study for Asthma-COPD Overlap Syndrome?

Research shows that health coaching can improve quality of life and reduce hospital admissions for people with COPD. Additionally, pulmonary rehabilitation, which includes exercise and education, is recommended for COPD patients to help control symptoms and improve health outcomes. ^{1 2 3 4 5}

How is the PushCon Model treatment different from other treatments for Asthma-COPD Overlap Syndrome?

The PushCon Model treatment is unique because it combines health coach consultations with usual care, focusing on personalized support and guidance, which is not typically part of standard treatments for Asthma-COPD Overlap Syndrome. ^{6 7 8 9 10}

Research Team

Rachel Willard-Grace, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

I speak English or Spanish.

I am 18 years old or older.

My symptoms are not under control.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intensive out-of-hospital coaching for frequently hospitalized COPD patients: a before-after feasibility study. [2023]

3. England 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Nurse-led multidisciplinary programme for patients with COPD in primary health care: a controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Recent updates in chronic obstructive pulmonary disease. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term chemotherapy-induced peripheral neuropathy among breast cancer survivors: prevalence, risk factors, and fall risk. [2022]

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

Supportive Care: Low Cost, High Value. [2021]

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

Cancer Survivors' Perspectives of Virtual Yoga for Chronic Chemotherapy-Induced Peripheral Neuropathy Pain During the COVID-19 Pandemic. [2023]

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

Assessment of Fall-Related Self-Efficacy: Characteristics that Influence the Perception of Patients with Chemotherapy-Induced Peripheral Neuropathy. [2022]

10. England 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. [2023]