Asthma Symptom Perception Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEF Interventional Session, Control Sessions, Control Booster, Active booster.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
Overview
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.
Interventions
- Behavioral PEF Interventional Session
3 sessions over 6 weeks for asthma management - Behavioral Control Sessions
3 sessions over 6 weeks for asthma management - Behavioral Control Booster
A single booster session after the 6-months assessments are completed. - Behavioral Active booster
A single booster session after the 6-months assessments are completed.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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 [Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention]
- Asthma Control Questionnaire [ACQ] scores [Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention]
- Asthma Quality of Life Questionnaire [AQLQ] scores [Time frame: at baseline, 1-month, 6-months, and 12-months post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Ichan School of Medicine at Mount Sinai — New York
- Albert Einstein College of Medicine — The Bronx
Identifiers
NCT: NCT06612294 · GCO 23-0259 · 1R01HL171676-01