Back to Trials
NCT06612294NARecruiting

Asthma Symptom Perception Study

Icahn School of Medicine at Mount Sinai

Start Date

9/18/2024

Completion Date

12/22/2028

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 Criteria

Age Range: 60 years to No maximum

Inclusion Criteria: * Age \> 60 years * English or Spanish speaking * Self-report or physician diagnosis of asthma \>1 year ago * Uncontrolled asthma Exclusion Criteria: * Dementia * Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses, * Congestive Heart Failure (CHF, New York Heart Association \[NYHA\] stages 4-5) * Cigarette smoking \>15 packs-years

Interventions

BEHAVIORAL

PEF Interventional Session

BEHAVIORAL

Control Sessions

BEHAVIORAL

Control Booster

BEHAVIORAL

Active booster

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Asthma

Locations

Ichan School of Medicine at Mount Sinai

New York, New York 10029

United States

Albert Einstein College of Medicine

The Bronx, New York 10461

United States