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NCT06612294 · ClinicalTrials.gov registry record · NA
Asthma Symptom Perception Study
A NA study of Asthma, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT06612294 is a NA study of Asthma that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 300 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06612294, a NA study of Asthma, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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 interve
Conditions Studied
Interventions
- BEHAVIORAL PEF Interventional Session
- BEHAVIORAL Control Sessions
- BEHAVIORAL Control Booster
- BEHAVIORAL Active booster
Study Locations (2)
New York
- Ichan School of Medicine at Mount Sinai - New York
- Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2028-12-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06612294
The ClinicalTrials.gov registry entry for NCT06612294 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (81% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which PEF Interventional Session is the first listed.
NCT06612294 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06612294 about?
NCT06612294 is a clinical study titled "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 perceptio...
What is the current status of trial NCT06612294?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-09-18. Estimated completion is 2028-12-22.
What conditions does trial NCT06612294 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT06612294?
The interventions under investigation include: PEF Interventional Session (BEHAVIORAL), Control Sessions (BEHAVIORAL), Control Booster (BEHAVIORAL), Active booster (BEHAVIORAL).
Who is sponsoring clinical trial NCT06612294?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06612294 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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