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NCT Number: NCT06612294

Asthma Symptom Perception Study

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ichan School of Medicine at Mount Sinai, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEF Interventional Session

Behavioral

3 sessions over 6 weeks for asthma management

Control Sessions

Behavioral

3 sessions over 6 weeks for asthma management

Control Booster

Behavioral

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

Active booster

Behavioral

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

Primary outcomes

  1. Peak expiratory flow (PEF) Values

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

    Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.

  2. Mean daily ICS dose used

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

    Mean daily ICS dose will be recorded for asthma medications

Secondary outcomes

  1. Number of participants using medications on ≥70% of days prescribed

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

    Adherence will be measured via the number of participants using medications on ≥70% of days prescribed.

  2. Participant personal best PEF percent

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

    Participant personal best PEF percent will be collected using the AM2 during assessments of perception of airflow limitation.

  3. Asthma Control Questionnaire [ACQ] scores

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

    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.

  4. Asthma Quality of Life Questionnaire [AQLQ] scores

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dhanya Chanumolu, MPH

CONTACT

[email protected]

332-777-5754

Juan Wisnivesky, MD, DrPH

CONTACT

[email protected]

212-824-7845

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Albert Einstein College of Medicine
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Yeshiva University

Registry information

Official study title

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

Acronym: ASP RCT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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