Recruiting

Asthma

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06612294

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

PEF Interventional Session

Control Sessions

Control Booster

Active booster

Study Details

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

Study ID

NCT06612294

Start date

Sep 18, 2024

Status verified date

Jul, 2026

Completion date

Dec 22, 2028

Anticipated

Primary completion date

Dec 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

placebo comparator: Control Group

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

Interventions

PEF Interventional Session

3 sessions over 6 weeks for asthma management

Control Sessions

3 sessions over 6 weeks for asthma management

Control Booster

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

Active booster

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

Primary outcome measure

  • Peak expiratory flow (PEF) Values [ Time Frame: at baseline, 1-month, 6-months, and 12-months post-intervention ]
  • Mean daily ICS dose used [ Time Frame: at baseline, 1-month, 6-months, and 12-months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Ichan School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Juan Winsnivesky

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-09.