Asthma Symptom Perception Study

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.
Brief Title
Asthma Symptom Perception Study
Central Contacts
Central Contact Role
Contact
Central Contact Phone
212-824-7845
Central Contact Email
juan.wisnivesky@mountsinai.org
Central Contact Role
Contact
Central Contact Phone
332-777-5754
Central Contact Email
dhanya.chanumolu@mountsinai.org
Completion Date
Completion Date Type
Estimated
Conditions
ASTHMA
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
Inclusion Criteria
Inclusion Criteria:

* Age \> 60 years
* English or Spanish speaking
* Self-report or physician diagnosis of asthma \>1 year ago
* Uncontrolled asthma

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
60 Years
NCT Id
NCT06612294
Org Class
Other
Org Full Name
Icahn School of Medicine at Mount Sinai
Org Study Id
GCO 23-0259
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults With Asthma
Primary Outcomes
Outcome Description
Perception accuracy of airflow limitation will be measured by perceived and actual PEF values.
Outcome Measure
Peak expiratory flow (PEF) Values
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Outcome Description
Mean daily ICS dose will be recorded for asthma medications
Outcome Measure
Mean daily ICS dose used
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Secondary Ids
Secondary Id
1R01HL171676-01
Secondary Outcomes
Outcome Description
Adherence will be measured via the number of participants using medications on ≥70% of days prescribed.
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Outcome Measure
Number of participants using medications on ≥70% of days prescribed
Outcome Description
Participant personal best PEF percent will be collected using the AM2 during assessments of perception of airflow limitation.
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Outcome Measure
Participant personal best PEF percent
Outcome Description
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.
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Outcome Measure
Asthma Control Questionnaire [ACQ] scores
Outcome Description
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.
Outcome Time Frame
at baseline, 1-month, 6-months, and 12-months post-intervention
Outcome Measure
Asthma Quality of Life Questionnaire [AQLQ] scores
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
60
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Feldman
Investigator Email
jonathan.feldman@einsteinmed.edu
Investigator Sponsor Organization
External
Study Department
YU - Ferkauf Graduate School of Psychology
Study Division
Not Applicable
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES