RECRUITING

Asthma Symptom Perception Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Trial of Perception of Airflow Limitation Training to Improve Outcomes for Older Adults with Asthma

Quick Facts

Study Start:2024-09-18
Study Completion:2028-12-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06612294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 60 years
  2. * English or Spanish speaking
  3. * Self-report or physician diagnosis of asthma \>1 year ago
  4. * Uncontrolled asthma
  1. * Dementia
  2. * Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses,
  3. * Congestive Heart Failure (CHF, New York Heart Association \[NYHA\] stages 4-5)
  4. * Cigarette smoking \>15 packs-years

Contacts and Locations

Study Contact

Juan Wisnivesky, MD, DrPH
CONTACT
212-824-7845
juan.wisnivesky@mountsinai.org
Dhanya Chanumolu, MPH
CONTACT
332-777-5754
dhanya.chanumolu@mountsinai.org

Principal Investigator

Juan Wisnivesky, MD, DrPH
PRINCIPAL_INVESTIGATOR
Division Chief, General Internal Medicine

Study Locations (Sites)

Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Juan Wisnivesky, MD, DrPH, PRINCIPAL_INVESTIGATOR, Division Chief, General Internal Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2028-12-22

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2028-12-22

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma