Actively Recruiting
Asthma Symptom Perception Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-08-26
300
Participants Needed
2
Research Sites
222 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
A
Albert Einstein College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Asthma affects 8% of the United States population ages \>60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire \[ACQ\] scores), quality of life (Asthma Quality of Life Questionnaire \[AQLQ\] scores), and emergency department and hospital use, and test the intervention's impact on mean daily ICS dose used (daily maintenance and as needed). Data will be collected at baseline, 1-month, 6-months (primary analyses of effectiveness) and 12-months post-intervention. In secondary analyses, the research team will test the sustainability of treatment effects with vs. without the booster treatment session (active booster vs. attention control booster) delivered immediately after the 6-month assessment on outcomes at 12-months.
CONDITIONS
Official Title
Asthma Symptom Perception Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 60 years
- English or Spanish speaking
- Self-report or physician diagnosis of asthma >1 year ago
- Uncontrolled asthma
You will not qualify if you...
- Dementia
- Chronic obstructive pulmonary disease (COPD) or other chronic respiratory illnesses
- Congestive Heart Failure (New York Heart Association [NYHA] stages 4-5)
- Cigarette smoking >15 pack-years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
2
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Not Yet Recruiting
Research Team
J
Juan Wisnivesky, MD, DrPH
CONTACT
D
Dhanya Chanumolu, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here