Asthma Symptom Perception Study (ASP RCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: PEF Interventional Session; Behavioral: Active booster; Behavioral: Control Booster; Behavioral: Control Sessions

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Wisnivesky, MD, DrPH; Phone Number: 212-824-7845; Email: juan.wisnivesky@mountsinai.org
• Study Contact Backup: Name: Dhanya Chanumolu, MPH; Phone Number: 332-777-5754; Email: dhanya.chanumolu@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Ichan School of Medicine at Mount Sinai
      • Contact: Dhanya Chanumolu, MPH; Phone Number: 332-777-5754; Email: dhanya.chanumolu@mountsinai.org
      • Principal Investigator: Juan Winsnivesky
    • The Bronx, New York, United States, 10461
      • Not yet recruiting
      • Albert Einstein College Of Medicine
      • Contact: Juliana Rodriguez; Phone Number: (718)-862-1722; Email: juliana.rodriguez@einsteinmed.edu
      • Principal Investigator: Jonathan Feldman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEF group with active booster; This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.	Behavioral: PEF Interventional Session; 3 sessions over 6 weeks for asthma management; Behavioral: Active booster; A single booster session after the 6-months assessments are completed.
Experimental: PEF group with control booster; This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point.	Behavioral: PEF Interventional Session; 3 sessions over 6 weeks for asthma management; Behavioral: Control Booster; A single booster session after the 6-months assessments are completed.
Placebo Comparator: Control Group; This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.	Behavioral: Control Booster; A single booster session after the 6-months assessments are completed.; Behavioral: Control Sessions; 3 sessions over 6 weeks for asthma management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak expiratory flow (PEF) Values	Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.	at baseline, 1-month, 6-months, and 12-months post-intervention
Mean daily ICS dose used	Mean daily ICS dose will be recorded for asthma medications	at baseline, 1-month, 6-months, and 12-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants using medications on ≥70% of days prescribed	Adherence will be measured via the number of participants using medications on ≥70% of days prescribed.	at baseline, 1-month, 6-months, and 12-months post-intervention
Participant personal best PEF percent	Participant personal best PEF percent will be collected using the AM2 during assessments of perception of airflow limitation.	at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Control Questionnaire [ACQ] scores	The ACQ is a self-reported questionnaire that assess asthma beliefs about asthma control. The ACQ is an instrument, full scale from 0-6, higher score indicates more impairment.	at baseline, 1-month, 6-months, and 12-months post-intervention
Asthma Quality of Life Questionnaire [AQLQ] scores	The AQLQ assess asthma beliefs about asthma quality of life. The AQLQ is an instrument, full scale from 1-7, higher score indicates better health outcomes.	at baseline, 1-month, 6-months, and 12-months post-intervention

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Albert Einstein College of Medicine; Yeshiva University
• Investigators: Principal Investigator: Juan Wisnivesky, MD, DrPH, Division Chief, General Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): December 22, 2028
• Study Completion (Estimated): December 22, 2028

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: GCO 23-0259; 1R01HL171676-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: The research team will provide data sets and associated documents to the NIH study Program Official within timelines described in the NIH Policy for Data Sharing from Clinical Trials and Epidemiological Studies - no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the clinical trial has been published - whichever comes first.
• IPD Sharing Access Criteria: Anyone who wishes to access the data. The research team will prepare public use, de-identified datasets which will be uploaded to the Inter-university Consortium for Political and Social Research (ICPSR) repository once the main study aims manuscripts have been published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No