RecruitingNot ApplicableNCT06612294

Asthma Symptom Perception Study

A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

300 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how well older adults with asthma are able to perceive their own asthma symptoms. Older people sometimes underestimate how bad their breathing is, which can delay treatment. The study aims to better understand this gap and find ways to help. **You may be eligible if...** - You are over 60 years old - You speak English or Spanish - You have been diagnosed with asthma by a doctor, or have self-reported asthma for more than 1 year - Your asthma is currently uncontrolled **You may NOT be eligible if...** - You have dementia - You have COPD, emphysema, or other chronic lung conditions - You have congestive heart failure or other serious heart disease - You are unable to complete the required assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPEF Interventional Session

3 sessions over 6 weeks for asthma management

BEHAVIORALControl Sessions

3 sessions over 6 weeks for asthma management

BEHAVIORALControl Booster

A single booster session after the 6-months assessments are completed.

BEHAVIORALActive booster

A single booster session after the 6-months assessments are completed.


Locations(2)

Ichan School of Medicine at Mount Sinai

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

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NCT06612294


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