Asthma Symptom Perception Study

NCT06612294 | Recruiting DMC

• 2 other identifiers: GCO 23-02591R01HL171676-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  at baseline, 1-month, 6-months, and 12-months post-intervention

• Asthma Control Questionnaire [ACQ] scores

  at baseline, 1-month, 6-months, and 12-months post-intervention

• Asthma Quality of Life Questionnaire [AQLQ] scores

  at baseline, 1-month, 6-months, and 12-months post-intervention

Study Arms (3)

PEF group with active booster

EXPERIMENTAL

This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.

Behavioral: PEF Interventional Session; Behavioral: Active booster

PEF group with control booster

EXPERIMENTAL

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; Behavioral: Control Booster

Control Group

PLACEBO COMPARATOR

This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.

Behavioral: Control Sessions; Behavioral: Control Booster

Interventions

PEF Interventional Session BEHAVIORAL

3 sessions over 6 weeks for asthma management

PEF group with active booster; PEF group with control booster

Control Sessions BEHAVIORAL

3 sessions over 6 weeks for asthma management

Control Group

Control Booster BEHAVIORAL

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

Control Group; PEF group with control booster

Active booster BEHAVIORAL

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

PEF group with active booster

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• English or Spanish speaking
• Self-report or physician diagnosis of asthma \>1 year ago
• Uncontrolled asthma

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Albert Einstein College of Medicine: collaborator
• Yeshiva University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Juan Wisnivesky, MD, DrPH

  Division Chief, General Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Wisnivesky, MD, DrPH

CONTACT

212-824-7845; juan.wisnivesky@mountsinai.org

Dhanya Chanumolu, MPH

CONTACT

332-777-5754; dhanya.chanumolu@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Research Coordinators conducting interviews and all investigators will be blinded to treatment allocation. Project staff will be assigned as Care Coaches for the intervention and the control treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, General Internal Medicine

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): December 22, 2028
• Study Completion (Estimated): December 22, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

US (2)