An interventional study of Self-Management Support and COPD Education in Chronic Obstructive Pulmonary Disease, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
The Icahn School of Medicine at Mount Sinai will conduct a randomized controlled trial of a self-management support intervention for predominantly minoritized and low-income adults with chronic obstructive pulmonary disease (COPD). The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations. The research team will compare this intervention with an attention control group to evaluate the effects on medication adherence, COPD symptoms, inhaler technique, physical activity and exercise capacity at 6 months, and at 12 months to examine sustainability of treatment effects. The research team will also examine hospitalizations and emergency department visits at 12 months. The study will recruit 300 participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn, ensuring diverse representation. Health coaches from the VNS Health will deliver the intervention, guided by a detailed training manual. Weekly conference calls will address logistical and protocol-related issues.
The Icahn School of Medicine at Mount Sinai is the lead and only site of recruitment for this project. Research study activities will be conducted at practices across the Mount Sinai Health System. The research team will identify a patient pool through the electronic health record. The research team will recruit 300 (150 per arm) participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn in NYC. These practices provide care to a diverse population with considerable sociodemographic diversity (\~40% Latino and \~30% Black, \~50% with household incomes \<$1,350/month). Randomization will occur 1 month after the baseline interview (and after the devices are returned). Randomization will be in blocks of variable size (4 to 6) and stratified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria B or E. The study's main outcomes will be assessed at 6 months and sustainability of treatment effects at 12 months. The intervention will be delivered by community health workers (CHW)health coaches employed by VNS Health. The research team will follow a detailed intervention training manual and Manual of Operations to guide CHWs through the intervention. The CHWs will also attend a 90-minute monthly group meeting to discuss cases and hear presentations on topics of their choosing for skills and knowledge development. The research team will meet by conference call weekly to discuss logistical issues, refinement of protocol, and other issues pertaining to the study. The project manager will email any modifications to the IRB and research coordinator within one day of receiving approval. The project manager will also email a copy of the amendment approval letter. Mount Sinai will abide by IRB policies as serving site.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 300 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Self-Management Support
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.
Behavioral: COPD Education
The intervention will be delivered by CHWs in person and supplemented with telephone or video encounters over 6 months. The intervention comprises six core elements: engagement, intake, self-management assessment, barrier screening, actions to address identified barriers, and follow-up/maintenance support.
Also known as: SaMBA-COPD
The attention control is where CHWs will provide COPD education using the COPD 1-2-3 booklet. The attention control will consist of 6 CHW visits (approximately 1 per month) with the patient and care giver in their home or via video conference, per patient preference.
COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is a validated measure of the impact of COPD on a person's life. COPD symptoms will be measured by self-report using the CAT. Full range from 0-40, with higher scores indicating a more severe impact of COPD on a patient's life.
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of participants who adhere to ≥ 80% of prescribed actuations
Adherence will be measured by the number of participants who adhere to ≥ 80% of prescribed actuations (doses).
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Inhaler Technique
Participants will be observed performing an inhalation from their COPD controller medication. Participant inhaler technique will be scored using a validated checklist. Higher score indicates better health outcomes. For metered dose and dry powdered inhalers, 0-7 For Ellipta devices, 0-9 For Respimat devices, 0-12
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of steps counted on Actigraph
Physical activity will be measured by total number of steps counted on triaxial accelerometer (Actigraph).
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Quality of life measured using the Clinical COPD Questionnaire (CCQ)
The CCQ is a 10-item questionnaire scored from 0 to 6 for each item (0 being never and 6 being all the time, with higher scores representing worse quality of life). The total score is 0-60.
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Number of participants with hospitalizations
Number of participants with hospitalizations for COPD-related events obtained from the Statewide Planning and Research Cooperative System (SPARCS).
Time frame: at Baseline and at 12 months
Number of participants with emergency department (ED) visits
Number of participants with ED visits obtained from the Statewide Planning and Research Cooperative System (SPARCS).
Time frame: at Baseline and at 12 months
Six Minute Walk Test (6MWT) to measure Exercise Capacity
The 6MWT measures the total the distance walked by the participant over 6 minutes on a closed track.
Time frame: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Sap, Analytic code
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Icahn School of Medicine at Mount Sinai