Perception Training for Asthma

(ASP RCT Trial)

Recruiting at 2 trial locations

Overseen By Juan Wisnivesky, MD, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Controller medications

Disqualifiers: Dementia, COPD, CHF, smoking

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults with asthma become more aware of their breathing limitations, potentially leading to improved asthma management. Participants will learn to recognize airway obstruction through feedback on their breathing and receive motivational support to change their asthma care habits. The study involves 300 adults over 60 with uncontrolled asthma who use daily or as-needed controller medications. Sessions, including the PEF Interventional Session (focused on peak expiratory flow measurement), will aim to improve lung function, asthma control, and quality of life, while reducing emergency visits. Ideal candidates have asthma that disrupts their daily activities and have had the condition for over a year. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance asthma management for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants are on controller medications, which suggests you may continue your current asthma treatments.

What prior data suggests that this perception training intervention is safe for older adults with asthma?

Research has shown that the PEF Interventional Session, which combines feedback on peak expiratory flow (PEF) with motivational interviewing, is safe. In an earlier study, patients who participated in this program did not report any serious side effects. This approach helps participants understand and manage their asthma by learning to recognize airflow limitations.

The initial trial found that this method not only improved asthma symptoms but was also well-tolerated by older adults, who did not experience harmful side effects. The intervention focuses on education and self-awareness, which typically carries fewer risks than treatments involving medication.

Overall, current evidence supports the safety of this intervention for older adults managing asthma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about perception training for asthma because it focuses on retraining how people perceive their breathing, which is a fresh approach compared to traditional medications like inhalers or bronchodilators. Unlike typical treatments that aim to directly open airways or reduce inflammation, this method works on improving the patients' awareness and response to their breathing patterns. This could lead to better self-management of asthma symptoms and possibly reduce the reliance on medications, offering a complementary strategy to existing treatments.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that teaching older adults to recognize their asthma symptoms more accurately can lead to better health outcomes. In this trial, participants in the PEF group with active booster will receive feedback on their ability to blow air out of their lungs, combined with motivational conversations. This aims to improve their ability to exhale quickly and increase awareness of breathing difficulties. Previous studies have tested this approach and shown promising results in improving overall asthma control. These findings suggest that when older adults better understand their breathing issues, they can manage their asthma more effectively. ^{2 6 7 8 9}

Who Is on the Research Team?

Juan Wisnivesky, MD, DrPH

Principal Investigator

Division Chief, General Internal Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 60 years old.

I was diagnosed with asthma over a year ago.

My asthma is not under control.

Exclusion Criteria

I do not have advanced heart failure.

Dementia

Cigarette smoking >15 packs-years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intervention or control sessions over 6 weeks

6 weeks

3 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 1-month, 6-months, and 12-months post-intervention

Booster Session

Participants receive an active or control booster session at the 6-month time point

1 session

What Are the Treatments Tested in This Trial?

Interventions

• Active booster
• Control Booster
• Control Sessions
• PEF Interventional Session

Trial Overview 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.

How Is the Trial Designed?

Group I: PEF group with control booster Experimental Treatment 2 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 booster Experimental Treatment 2 Interventions

This arm will have 3 intervention sessions over 6 weeks and an additional (active) session at 6-month time point.

Group III: Control Group Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Yeshiva University

Collaborator

Trials

13

Recruited

2,600+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

In a study involving 227 children with asthma, symptom perception interventions led to an increase in the identification of asthma triggers, particularly when combined with home monitoring and feedback.

However, while identifying more triggers can help manage asthma, it was also associated with a decrease in quality of life, indicating that awareness of triggers may increase the perceived burden of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Symptom Perception Interventions on Trigger Identification and Quality of Life in Children with Asthma. Janssens, T., Harver, A.[2018]

Providing feedback on peak expiratory flow (PEF) predictions significantly improved children's accuracy in perceiving their respiratory function, leading to less under-perception and greater awareness of respiratory compromise.

Children who received feedback showed better adherence to inhaled corticosteroids and increased use of quick-relief medications, suggesting that this intervention can enhance asthma management in ethnic minority, inner-city populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of peak flow values followed by feedback improves perception of lung function and adherence to inhaled corticosteroids in children with asthma. Feldman, JM., Kutner, H., Matte, L., et al.[2013]

In a study of 78 asthmatic children aged 7 to 16, two methods for assessing symptom perception were compared, revealing that resistive loading techniques did not correlate with children's ability to perceive their asthma symptoms or predict asthma-related health issues.

In contrast, subjective symptom estimates recorded by the children showed a significant relationship with asthma morbidity, suggesting that monitoring symptoms in real-life situations is more effective for identifying children at risk for severe asthma complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom perception in pediatric asthma: resistive loading and in vivo assessment compared. Fritz, GK., Adams, SK., McQuaid, EL., et al.[2007]

Asthmatic patients can be effectively trained to accurately estimate their peak flow measurements, showing a very high correlation (0.993) between estimated peak flow (EPF) and measured peak flow (PF) even after significant drops in airflow.

This ability to estimate airflow drops can help in early recognition of acute exacerbations, potentially improving medication compliance, but it should be used alongside regular peak flow measurements, not as a replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training perception of acute airflow obstruction. Silverman, B., James, C., Misra, S., et al.[2007]

In a study of 100 asthma patients over 28 days, two methods were used to assess how well patients perceived changes in their airflow, revealing that 24 patients were identified as poor perceivers and 13 as exaggerated perceivers.

The study found a significant correlation between poor or exaggerated perception of asthma symptoms and the presence of psychological disorders, with 30% of poor perceivers and 54% of exaggerated perceivers having a psychological condition, suggesting that perception of asthma severity may not always align with actual clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of natural fluctuations in peak flow in asthma: clinical severity and psychological correlates. Rushford, N., Tiller, JW., Pain, MC.[2019]

Healthy individuals improved their ability to discriminate between different respiratory sensations after training that involved breathing through circuits with varying air flow resistance, indicating that targeted training can enhance respiratory awareness.

The training method, which included performance feedback and gradually increasing similarity of tasks, led to significant improvements in discrimination abilities, suggesting potential applications for helping asthma patients better manage their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving recognition of respiratory sensations in healthy adults. Stout, C., Kotses, H., Creer, TL.[2019]

Accurate perception of asthma symptoms is crucial for timely diagnosis and management, but not all patients can effectively recognize their symptoms, leading to either hyperperception or poor perception of airflow limitation.

Objective measures of airflow limitation are essential for patients who struggle with symptom perception, and there are training regimens available to help improve symptom recognition in both children and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perception of Asthma Severity in Children. Still, L., Dolen, WK.[2018]

In a study involving 150 subjects with poorly controlled asthma, a peak flow-based action plan significantly reduced emergency department visits for asthma compared to a symptom-based plan and no action plan, indicating its effectiveness in preventing severe exacerbations.

While all groups showed improvement in asthma control over 6 months, only the peak flow-based action plan group demonstrated a statistically significant reduction in the need for urgent treatment, highlighting its potential as a valuable management tool for asthma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a peak flow-based action plan in the prevention of exacerbations of asthma. Cowie, RL., Revitt, SG., Underwood, MF., et al.[2019]

In a study of 24 adult asthma patients, it was found that their ability to perceive their own pulmonary functioning was poor, indicating a lack of awareness about their condition.

Despite using peak flow meters daily, patients did not show significant improvement in their self-perception of pulmonary function, suggesting that simply using these devices may not enhance awareness of asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak flow meters: are they monitoring tools or training devices? Reeder, KP., Dolce, JJ., Duke, L., et al.[2019]

In a study involving 90 children aged 7-14 with moderate asthma, adding peak expiratory flow (PEF) recordings to a symptom-based self-management plan did not improve asthma outcomes, including symptom scores or lung function, over 12 weeks.

Children primarily relied on their symptoms to manage their asthma, as they increased inhaled steroids when their PEF was above 70% of their best, indicating that PEF measurements did not enhance their self-management decisions during acute episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak flow monitoring for guided self-management in childhood asthma: a randomized controlled trial. Wensley, D., Silverman, M.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9940152/

A Pilot Randomized Controlled Trial of an Intervention to ... The objective of this pilot randomized controlled trial was to compare PEF feedback combined with motivational interviewing (MI), a counseling intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01979224?term=Asthma&firstPost=2013-10-01_2013-11-28&viewType=Table&rank=6

Efficacy of Educational Intervention for Parents of Children ... With the collected data was performed a database clinical history, ACT score, FEV1 and PEF, results of each patient and personal data for future location, the ...

3. publications.ersnet.org publications.ersnet.org/content/erj/31/4/790

Effectiveness of pharmacist intervention for asthma control ... PEF: PEF morning remained status quo, PEF evening was significantly improved within the intervention group. Knowledge: significantly improved after 12 months ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9985121/

Evaluation of the Effectiveness of Teach-back Training on ... The results showed the effectiveness of teach-back training in managing asthmatic patients. Therefore, this intervention can be used as an effective method to ...

5. resmedjournal.com resmedjournal.com/article/S0954-6111%2817%2930287-1/fulltext

Real-life effectiveness of asthma treatment with a fixed ... The results show significant improvements in all effectiveness outcomes that were subject to statistical analysis (ACT total and domain scores, AQLQ total and ...

6. withpower.com withpower.com/trial/phase-asthma-8-2024-d1368

Perception Training for Asthma (ASP RCT Trial) The ASP RCT medical study, being run by Icahn School of Medicine at Mount Sinai, is evaluating whether PEF Interventional Session will have tolerable side ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542881/

Methods - Nocturnal temperature-controlled laminar airflow ... The PED included PEF measurements (using the trial electronic PEF device), OCS dose, reliever medication use and nocturnal asthma symptoms. Participants were ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/02770903.2025.2475452

Safety and effectiveness of mepolizumab in adult patients ... Mepolizumab was well tolerated in Indian adults with SAEP and improved asthma control and health-related quality of life.

9. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-019-1119-6

Peak expiratory flow as an endpoint for clinical trials in asthma Pre-dose PEF measured at home could be an alternative primary lung function endpoint for trials in adolescent and adult patients with asthma.