PEF Interventional Session
Behavioral3 sessions over 6 weeks for asthma management
NCT Number: NCT06612294
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Ichan School of Medicine at Mount Sinai, New York, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 sessions over 6 weeks for asthma management
3 sessions over 6 weeks for asthma management
A single booster session after the 6-months assessments are completed.
A single booster session after the 6-months assessments are completed.
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.
Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention
Mean daily ICS dose will be recorded for asthma medications
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dhanya Chanumolu, MPH
CONTACT
Juan Wisnivesky, MD, DrPH
CONTACT
Icahn School of Medicine at Mount Sinai
Other
A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
Acronym: ASP RCT
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