Clinical trial NCT06612294: Asthma Symptom Perception Study
Official title: A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults with Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Yeshiva University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-25
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Peak expiratory flow (PEF) Values
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
measure: Mean daily ICS dose used
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
Secondary outcomes:
measure: Number of participants using medications on ≥70% of days prescribed
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
measure: Participant personal best PEF percent
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
measure: Asthma Control Questionnaire [ACQ] scores
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
measure: Asthma Quality of Life Questionnaire [AQLQ] scores
timeFrame: at baseline, 1-month, 6-months, and 12-months post-intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Ichan School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Division Chief, General Internal Medicine
name: Juan Wisnivesky, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References: