Asthma Symptom Perception Study

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06612294
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PEF Interventional Session — BEHAVIORAL
    3 sessions over 6 weeks for asthma management
  • Control Sessions — BEHAVIORAL
    3 sessions over 6 weeks for asthma management
  • Control Booster — BEHAVIORAL
    A single booster session after the 6-months assessments are completed.
  • Active booster — BEHAVIORAL
    A single booster session after the 6-months assessments are completed.

Study Details

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.

Key Dates

Start date
Sep 18, 2024
Status verified
Aug 2025
Primary completion
Dec 22, 2028
Completion
Dec 22, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PEF group with active booster
    This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.
  • Experimental: PEF group with control booster
    This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point.
  • Placebo Comparator: Control Group
    This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.

Primary Outcome Measure

Peak expiratory flow (PEF) Values [ Time Frame: at baseline, 1-month, 6-months, and 12-months post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Dhanya Chanumolu, MPH
[email protected]
332-777-5754
Juan Winsnivesky (PRINCIPAL_INVESTIGATOR)
Albert Einstein College of MedicineThe BronxNew York10461
Juliana Rodriguez
[email protected]
(718)-862-1722
Jonathan Feldman (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Ichan School of Medicine at Mount Sinai· New York, NYAlbert Einstein College of Medicine· The Bronx, NY

Related Studies