Asthma Symptom Perception Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-18

Study Completion Date

2028-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Research Coordinators conducting interviews and all investigators will be blinded to treatment allocation. Project staff will be assigned as Care Coaches for the intervention and the control treatments.

Study Groups

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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.

Group Type EXPERIMENTAL

PEF Interventional Session

Intervention Type BEHAVIORAL

3 sessions over 6 weeks for asthma management

Active booster

Intervention Type BEHAVIORAL

A single booster session after the 6-months assessments are completed.

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.

Group Type EXPERIMENTAL

PEF Interventional Session

Intervention Type BEHAVIORAL

3 sessions over 6 weeks for asthma management

Control Booster

Intervention Type BEHAVIORAL

A single booster session after the 6-months assessments are completed.

Control Group

This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.

Group Type PLACEBO_COMPARATOR

Control Sessions

Intervention Type BEHAVIORAL

3 sessions over 6 weeks for asthma management

Control Booster

Intervention Type BEHAVIORAL

A single booster session after the 6-months assessments are completed.

Interventions

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PEF Interventional Session

3 sessions over 6 weeks for asthma management

Intervention Type BEHAVIORAL

Control Sessions

3 sessions over 6 weeks for asthma management

Intervention Type BEHAVIORAL

Control Booster

A single booster session after the 6-months assessments are completed.

Intervention Type BEHAVIORAL

Active booster

A single booster session after the 6-months assessments are completed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No