Home-based Care Coaching for Chronic Obstructive Pulmonary Disease

(SAMBA COPD Trial)

Overseen By Jennifer Utkin, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: LAMA, LABA, ICS

Disqualifiers: Dementia

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 90

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adults with chronic obstructive pulmonary disease (COPD) manage their condition better at home. It will test a new support program called Comprehensive Patient-Centered Home-based Care Coaching, which includes home-based rehabilitation and proactive treatments, like steroids and antibiotics, to prevent flare-ups. Researchers will compare participants to a control group receiving general education to determine if the new method improves medication use, symptom control, and physical activity. The trial seeks English or Spanish-speaking adults with COPD who are currently using certain inhaler medications. It is especially interested in those experiencing symptoms that affect daily life. As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance daily life for those with COPD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, since the study focuses on medication adherence, you may need to continue taking your prescribed COPD medications.

What prior data suggests that this self-management support intervention is safe for COPD patients?

Research has shown that a patient-focused, home-based care approach for COPD (chronic obstructive pulmonary disease) has been well received by patients in past studies. This care includes home-based pulmonary rehabilitation, which helps patients exercise and manage symptoms at home. An earlier study found that this approach led to positive results and was generally well accepted by participants.

Additionally, a small initial study of a similar home-based program for COPD showed that participants could follow the program without major problems. The study reported no significant negative effects, suggesting the treatment is safe for people.

While the current trial's safety data is not yet available, existing evidence suggests that home-based care coaching is generally safe and well-tolerated by people living with COPD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing Chronic Obstructive Pulmonary Disease (COPD) through comprehensive home-based care coaching. Unlike standard COPD treatments, which often focus solely on medication and hospital-based interventions, this method integrates community health workers to provide personalized support right at home. The study emphasizes screening for and managing barriers to COPD control, offering home-based pulmonary rehabilitation, and proactive treatment of exacerbations with pre-emptive prescriptions. This holistic, patient-centered approach could lead to more effective management of COPD and improve patients' quality of life.

What evidence suggests that this trial's treatments could be effective for COPD?

Research has shown that performing pulmonary rehabilitation exercises at home can help people with COPD manage their symptoms more effectively. Studies have found that these programs can enhance exercise capacity and ease breathing. In this trial, participants in the Self-Management Support (SaMBA-COPD) arm will receive comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation. This approach also includes using oral steroids and antibiotics to prevent flare-ups, effectively managing worsening symptoms. Early results suggest that self-management of COPD is well-received and can improve condition control. Overall, these strategies aim to make living with COPD easier and may reduce the need for hospital visits. ^{1 3 6 7 8}

Who Is on the Research Team?

Alex Federman, MD, MPH

Principal Investigator

Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Are You a Good Fit for This Trial?

This trial is for adults with COPD who are mostly from minoritized and low-income backgrounds. Participants should be able to follow a home-based care program, including pulmonary rehabilitation and medication management. The study excludes individuals who do not meet the specific inclusion criteria set by the researchers.

Inclusion Criteria

I am 40 years old or older.

My COPD is classified as GOLD B or E, indicating a higher risk of symptoms and flare-ups.

I am prescribed LAMA, LABA, ICS, or a combination for my condition.

Exclusion Criteria

I do not have dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation, oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations

6 months

Monthly 90-minute sessions

Follow-up

Participants are monitored for sustainability of treatment effects, hospitalizations, and emergency department visits

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Patient-Centered Home-based Care Coaching

Trial Overview

The trial tests a self-management support intervention that includes comprehensive screening, targeted management of COPD barriers, home-based rehab, and preemptive medication for flare-ups. It compares these methods against standard attention control to see if they improve COPD outcomes over 6-12 months.

How Is the Trial Designed?

Group I: Selt-Management Support (SaMBA-COPD) Experimental Treatment 1 Intervention

Participants receiving SaMBA-COPD intervention by community health workers (CHW). Participants will receive comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation, oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations.

Group II: Attention-Matched Support Placebo Group 1 Intervention

Participants will receive support by CHWs providing education using the COPD 1-2-3 booklet. Participants will receive similar visit frequencies but will not undergo barrier screening or targeted interventions.

Comprehensive Patient-Centered Home-based Care Coaching is already approved in United States for the following indications:

Approved in United States as Comprehensive Patient-Centered Home-based Care Coaching for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

VNS Health

Collaborator

Trials

2

Recruited

320+

Baystate Medical Center

Collaborator

Trials

67

Recruited

44,500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Health coaching provided by a respiratory therapist or nurse significantly improved self-management abilities in patients with COPD after hospital discharge, as evidenced by a greater increase in Chronic Respiratory Disease Questionnaire mastery scores compared to usual care.

In a study of 215 COPD patients, 55% of those receiving health coaching achieved a clinically meaningful improvement in self-management skills, highlighting the effectiveness of this intervention in reducing re-hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Health Coaching Delivered by a Respiratory Therapist or Nurse on Self-Management Abilities in Severe COPD: Analysis of a Large Randomized Study. Benzo, R., McEvoy, C.[2020]

A study involving 72 COPD patients showed that an unsupervised home-based pulmonary rehabilitation program significantly improved dyspnea and self-efficacy after three months compared to a control group.

While both groups saw improvements in overall COPD symptoms, the experimental group experienced more pronounced benefits, indicating that home-based rehabilitation can be an effective self-management strategy for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of an unsupervised home-based pulmonary rehabilitation with self-management program in patients with chronic obstructive pulmonary disease. Liou, HL., Lai, ZY., Huang, YT., et al.[2023]

A pilot study involving 50 patients with moderate to severe COPD tested a telephone-based health-coaching intervention, which significantly improved dyspnea levels and quality of life after 3 months, with 71% of participants showing meaningful improvements.

The intervention was well-accepted and demonstrated that motivational interviewing techniques can serve as an effective alternative to traditional pulmonary rehabilitation programs, especially for patients who have limited access to such services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Motivational Interviewing-Based Health Coaching on Quality of Life in Subjects With COPD. Rehman, H., Karpman, C., Vickers Douglas, K., et al.[2022]

Patients with COPD reported that participating in a 6-month health coaching self-management program helped them gain valuable insights into managing their condition and taking personal responsibility for their health.

The study highlighted the importance of support from healthcare professionals and the need to address individual challenges to improve the effectiveness of self-management programs for COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of a health coaching self-management program in patients with COPD: a qualitative content analysis. Wang, L., Mårtensson, J., Zhao, Y., et al.[2018]

A home-based pulmonary rehabilitation program for patients with very severe COPD receiving long-term oxygen treatment is both safe and effective, showing no complications from exercise.

Participants in the rehabilitation program significantly improved their exercise tolerance, as evidenced by a notable increase in the distance covered in a 6-minute walk test and a reduction in respiratory-related quality of life scores after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based pulmonary rehabilitation in very severe COPD: is it safe and useful? Fernández, AM., Pascual, J., Ferrando, C., et al.[2009]

In a case series involving 19 COPD patients, those with more advanced disease (group 1) showed significant improvements in patient activation, mastery, and anxiety after using an Internet-based health program with nurse-coach support, while the less advanced group (group 2) did not show similar benefits.

Both groups reported feeling more informed about COPD and experienced improvements in physical functioning, but group 1 particularly valued the nurse-coach support, which was deemed more important than the online program for building confidence in self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of an off-the-shelf online health resource with integrated nurse coaching to support self-management in COPD. Early, F., Young, JS., Robinshaw, E., et al.[2018]

A multicenter clinical trial with 375 COPD patients showed that a 12-week remote patient monitoring program with health coaching significantly improved both physical and emotional quality of life, as measured by the Chronic Respiratory Questionnaire (CRQ).

The intervention not only enhanced overall quality of life but also positively impacted self-management, daily physical activity, sleep, and reduced symptoms of depression, with benefits maintained even 24 weeks after the program ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Benzo, R., Hoult, J., McEvoy, C., et al.[2023]

A 9-week home-based pulmonary rehabilitation program for patients with severe COPD significantly improved exercise tolerance, as evidenced by increased distance covered in a 3-minute walk test, with these improvements maintained at 6 months.

Patients also experienced significant reductions in dyspnea and fatigue after the rehabilitation program, indicating enhanced health-related quality of life, although the improvement in dyspnea was not sustained at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits of a home-based pulmonary rehabilitation program for patients with severe chronic obstructive pulmonary disease]. Regiane Resqueti, V., Gorostiza, A., Gáldiz, JB., et al.[2022]

A home-based pulmonary rehabilitation program with health coaching was found to be feasible and highly acceptable for patients with moderate to severe COPD, achieving an impressive adherence rate of 86% to the exercise routine.

While there was no significant difference in breathlessness levels, the program significantly improved self-management abilities, indicating its potential to empower patients in managing their condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Benzo, RP., Ridgeway, J., Hoult, JP., et al.[2023]

Home-based pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease (COPD) showed significant improvements in health-related quality of life and exercise capacity compared to standard care, based on a systematic review of 12 studies.

When compared to hospital-based rehabilitation, home-based programs did not demonstrate significant differences in health-related quality of life or exercise capacity, suggesting that home-based rehabilitation can be a viable alternative without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based pulmonary rehabilitation in chronic obstructive pulmonary disease patients. Vieira, DS., Maltais, F., Bourbeau, J.[2018]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06634810

Comprehensive Patient-Centered Home-based Care ...

The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10913921/

Feasibility Trial of a Comprehensive, Highly Patient ...

A highly patient-centered, self-management support intervention for people with COPD was well received by patients and associated with potential improvements.

3.

trial.medpath.com

trial.medpath.com/clinical-trial/3cfe9cf4db9e6b0b/nct06634810-patient-centered-home-care-coaching-copd

Comprehensive Patient-Centered Home-based Care ...

The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral ...

4.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-07779-9

Effectiveness of home-based pulmonary rehabilitation ...

This systematic review aimed to determine the effectiveness of home-based PR (HBPR) programs for COPD patients.

5.

database.clin-star.org

database.clin-star.org/display/project-5R34HL14374703

Comprehensive Home-based Self-management Support ...

Unfortunately, COPD self-management support programs have produced disappointing results and access to pulmonary rehabilitation is limited, indicating that new ...

6.

mountsinai.org

mountsinai.org/clinical-trials/comprehensive-patient-centered-home-based-care-coaching-for-copd-self-management

Comprehensive Patient-Centered Home-based Care ...

The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2542454823000449

Home-Based Physical Activity Program With Health ...

This 8-week pilot study aimed to determine the feasibility of a home-based physical activity program for participants with chronic obstructive pulmonary disease ...

8.

ctv.veeva.com

ctv.veeva.com/study/comprehensive-patient-centered-home-based-care-coaching-for-copd-self-management

Comprehensive Patient-Centered Home-based Care ...

The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral ...