Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612294
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Asthma Symptom Perception Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults with Asthma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASP RCT
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 interventions 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 interventions 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None