Asthma Symptom Perception Study
- Conditions
- Asthma
- Interventions
- Behavioral: PEF Interventional SessionBehavioral: Control SessionsBehavioral: Active boosterBehavioral: Control Booster
- Registration Number
- NCT06612294
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Age > 60 years
- English or Spanish speaking
- Self-report or physician diagnosis of asthma >1 year ago
- Uncontrolled asthma
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEF group with active booster PEF Interventional Session This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point. PEF group with active booster Active booster This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point. PEF group with control booster PEF Interventional Session This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point. PEF group with control booster Control Booster This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point. Control Group Control Sessions This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point. Control Group Control Booster This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.
- Primary Outcome Measures
Name Time Method Peak expiratory flow (PEF) Values 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.
Mean daily ICS dose used at baseline, 1-month, 6-months, and 12-months post-intervention Mean daily ICS dose will be recorded for asthma medications
- Secondary Outcome Measures
Name Time Method Number of participants using medications on ≥70% of days prescribed 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.
Participant personal best PEF percent 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.
Asthma Control Questionnaire [ACQ] scores 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.
Asthma Quality of Life Questionnaire [AQLQ] scores 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.
Trial Locations
- Locations (2)
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Ichan School of Medicine at Mount Sinai
🇺🇸New York, New York, United States