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Behavioral Intervention

Home-based Care Coaching for Chronic Obstructive Pulmonary Disease (SAMBA COPD Trial)

N/A

Recruiting

Led By Alex Federman, MD, MPH

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥40 years

Be older than 18 years old

Must not have

EHR documented dementia, as the research team's focus is on patients with capacity to independently perform self-care tasks.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 12 months

Summary

This trial will study a program to help adults with chronic obstructive pulmonary disease (COPD) who are mostly from minority and low-income backgrounds. The program will include screening for COPD barriers,

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on education and coaching rather than new medications or invasive procedures, side effects may be minimal but could include discomfort from increased physical activity or stress related to self-management of a chronic condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

COPD Assessment Test (CAT) Score

Number of participants who adhere to ≥ 80% of prescribed actuations

Secondary study objectives

Inhaler Technique

Number of participants with emergency department (ED) visits

Number of participants with hospitalizations

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Selt-Management Support (SaMBA-COPD)Experimental Treatment1 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 SupportPlacebo Group1 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.

0 / 2Eligibility criteria met