Perception Training for Asthma

(ASP RCT Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Perception Training for Asthma treatment?

Research shows that predicting peak expiratory flow (PEF) and receiving feedback can improve how well children with asthma perceive their lung function and stick to their medication. Additionally, symptom perception interventions can help children identify asthma triggers and improve their quality of life. ^{1 2 3 4 5}

Is Perception Training for Asthma safe for humans?

The studies reviewed do not report any safety concerns related to perception training for asthma, suggesting it is generally safe for humans. ^{1 4 5 6 7}

How is the PEF Interventional Session treatment for asthma different from other treatments?

The PEF Interventional Session treatment is unique because it focuses on training patients to better perceive their asthma symptoms by predicting and receiving feedback on their peak expiratory flow (PEF), which can improve their awareness of lung function and adherence to medication. This approach is different from standard treatments that primarily focus on medication without addressing symptom perception. ^{1 5 8 9 10}

Research Team

Juan Wisnivesky, MD, DrPH

Principal Investigator

Division Chief, General Internal Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

References

1. England 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. [2013]

2. Egypt pubmed.ncbi.nlm.nih.gov

Effects of Symptom Perception Interventions on Trigger Identification and Quality of Life in Children with Asthma. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of a peak flow-based action plan in the prevention of exacerbations of asthma. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Peak flow meters: are they monitoring tools or training devices? [2019]

5. England pubmed.ncbi.nlm.nih.gov

Perception of natural fluctuations in peak flow in asthma: clinical severity and psychological correlates. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Training perception of acute airflow obstruction. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Improving recognition of respiratory sensations in healthy adults. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Symptom perception in pediatric asthma: resistive loading and in vivo assessment compared. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

The Perception of Asthma Severity in Children. [2018]