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Behavioural Intervention

Perception Training for Asthma (ASP RCT Trial)

N/A
Recruiting
Led By Juan Wisnivesky, MD, DrPH
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 60 years
Self-report or physician diagnosis of asthma >1 year ago
Must not have
Chronic obstructive pulmonary disease (COPD) or other chronic respiratory illnesses
Congestive Heart Failure (CHF, New York Heart Association [NYHA] stages 4-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 1-month, 6-months, and 12-months post-intervention

Summary

This trial aims to help older adults with uncontrolled asthma by training them to better perceive airway obstruction and improve their asthma self-management behaviors. The intervention involves feedback through peak expiratory flow prediction and

Who is the study for?
This trial is for individuals aged 60 or older with uncontrolled asthma despite being on controller medications. Participants will be recruited from underserved inner-city medical practices in New York City. They must not have other health conditions that could interfere with the study.
What is being tested?
The study tests a training intervention to help patients better perceive airflow limitation through peak expiratory flow feedback, coupled with motivational interviewing. It aims to improve lung function, asthma control, and quality of life over sessions spanning six weeks.
What are the potential side effects?
Since this trial focuses on perception training and educational sessions rather than medication, there are no direct side effects like those associated with drugs. However, participants may experience discomfort or anxiety related to awareness of their breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 60 years old.
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I was diagnosed with asthma over a year ago.
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My asthma is not under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a chronic lung condition like COPD.
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I do not have advanced heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 1-month, 6-months, and 12-months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1-month, 6-months, and 12-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean daily ICS dose used
Peak expiratory flow (PEF) Values
Secondary study objectives
Asthma Control Questionnaire [ACQ] scores
Asthma Quality of Life Questionnaire [AQLQ] scores
Number of participants using medications on ≥70% of days prescribed
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PEF group with control boosterExperimental Treatment2 Interventions
This arm will have 3 intervention sessions over 6 weeks and a control booster session at the 6-month time point.
Group II: PEF group with active boosterExperimental Treatment2 Interventions
This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.
Group III: Control GroupPlacebo Group2 Interventions
This arm will have 3 control sessions over 6 weeks and a control booster session at 6-month time point.

Find a Location

Who is running the clinical trial?

Yeshiva UniversityOTHER
11 Previous Clinical Trials
2,322 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,532 Total Patients Enrolled
282 Trials studying Asthma
114,123 Patients Enrolled for Asthma
Albert Einstein College of MedicineOTHER
296 Previous Clinical Trials
11,689,153 Total Patients Enrolled
5 Trials studying Asthma
1,066 Patients Enrolled for Asthma
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,579 Total Patients Enrolled
14 Trials studying Asthma
10,591 Patients Enrolled for Asthma
Juan Wisnivesky, MD, DrPHPrincipal InvestigatorDivision Chief, General Internal Medicine
~200 spots leftby Dec 2028
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