Perception Training for Asthma

(ASP RCT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Juan Wisnivesky, MD, DrPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Controller medications

Disqualifiers: Dementia, COPD, CHF, smoking

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}

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.

I speak English or Spanish.

Exclusion Criteria

I do not have advanced heart failure.

Dementia

Cigarette smoking >15 packs-years

Trial 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 (Behavioural Intervention)
• Control Booster (Behavioural Intervention)
• Control Sessions (Behavioural Intervention)
• PEF Interventional Session (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Albert Einstein College of Medicine Bronx, NY

Ichan School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

Yeshiva University Collaborator

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

Albert Einstein College of Medicine Collaborator

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] Failure to detect respiratory compromise can lead to emergency healthcare use and fatal asthma attacks. The purpose of this study was to examine the effect of predicting peak expiratory flow (PEF) and receiving feedback on perception of pulmonary function and adherence to inhaled corticosteroids (ICS).

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

Effects of Symptom Perception Interventions on Trigger Identification and Quality of Life in Children with Asthma. [2018] Management of individual triggers is suboptimal in practice. In this project, we investigated the impact of symptom perception interventions on asthma trigger identification and self-reported asthma quality of life.

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] To determine the effect of a symptom-based and a peak flow-based action plan in preventing acute exacerbations in subjects with poorly controlled asthma.

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

Peak flow meters: are they monitoring tools or training devices? [2019] Previous studies have been inconclusive as to whether peak flow meter use teaches asthma patients to better perceive their own pulmonary functioning. This investigation utilized a delayed baseline design to determine if pulmonary awareness could be improved among a sample of 24 adult patients who compared daily peak expiratory flow rates (PEFR) with asthma symptom ratings. Results indicated that among this sample of adult patients: (i) perception of pulmonary functioning was poor, (ii) adherence to peak flow meter use was poor, and (iii) among patients who use peak flow meters daily, self-perception of pulmonary functioning did not improve significantly. Summary tables and descriptive statistics for pulmonary functioning are provided, and treatment implications are discussed.

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

Perception of natural fluctuations in peak flow in asthma: clinical severity and psychological correlates. [2019] Two methods of defining perception of asthma-related changes in airflow were compared, and relationships to clinical opinions of severity and assessments of psychological functioning were investigated. Perceived breathlessness (VAB) and peak expiratory flow (PEF) were recorded by 100 subjects for 28 days. Perception was defined by correlation of the two values and by the ratio of maximum change in PEF and related change in VAB. The latter method defined 24 poor perceivers (PP) and 13 exaggerated perceivers (EP), in whom presence of a psychological disorder was high (30% of PP, 54% of EP, compared to 8% of the remainder). Clinical severity in EP was assessed as greater than appeared warranted.

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

Peak flow monitoring for guided self-management in childhood asthma: a randomized controlled trial. [2006] We asked whether the addition of PEF recordings to a symptom-based self-management plan improved outcome in school children with asthma. In an open-randomized, parallel-group, controlled trial, we studied children aged 7-14 years with moderate asthma. After a 4-week run-in, 90 children were randomized to receive either PEF plus symptom-based management or symptom-based management alone for 12 weeks. Thresholds for action based on PEF were 70% of best (for increasing inhaled steroids) and 50% of best (for commencing prednisolone). Children were asked to perform twice-daily spirometry at home (using an electronic recording spirometer that revealed only PEF to the study group alone) and to record a symptom diary. The mean daily symptom score was the main outcome. There were no differences between groups in mean symptom score or in spirometric lung function, PEF, quality of life score, or reported use of health services over 12 weeks. During acute episodes, children responded to changes in symptoms by increasing their inhaled steroids at a mean value of PEF of greater than 70% of best so that overall PEF did not contribute to this important self-management decision. Knowledge of PEF did not enhance self-management even during acute exacerbations.

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

Training perception of acute airflow obstruction. [2007] Ten asthmatics selected for their tendency to experience frequent acute exacerbations were instructed in peak flow measurement. Each subject then recorded estimated peak flow (EPF) and measured peak flow (PF) at home twice daily. Data for up to 56 consecutive observations (4 weeks) per subject were analyzed. The correlation coefficient between EPF and PF following PF drops of 15% was .993 overall and was not significantly different following PF drops even greater than 25%. The absolute and proportional differences between PF and EPF were also not significantly affected by the magnitude of PF drop but decreased over time indicating improved accuracy of estimates with practice. Asthmatics can be trained to estimate accurately acute drops in airflow. Such ability has not been demonstrated in prior studies which utilized verbal symptom reports as indicators of subjective perception of airflow. Accurate perception would be a useful aid in achieving early recognition of acute exacerbations and in improving medication compliance. It is an adjunct to regular peak flow measurement, not a substitute for it.

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

Improving recognition of respiratory sensations in healthy adults. [2019] In two discrimination training studies, we noted improvements in the ability of healthy individuals to discriminate between respiratory sensations. We trained individuals to discriminate between respiratory sensations elicited during inspiration in Experiment 1 and during expiration in Experiment 2. We elicited respiratory sensations by having participants breathe through circuits that differed in their resistance to air flow. Training, in both experiments, was conducted within the context of a task in which individuals judged which member of a series of respiratory circuit pairs was easier to breathe through. To improve the accuracy of judgments, we gave participants feedback of their performance, and we faded air flow resistance. The latter procedure consisted of presenting circuit pairs in order of increasing similarity. Individuals who received performance feedback with fading of air flow resistance demonstrated reliable improvements in discrimination from pre- to posttraining in both experiments, but controls, who received either performance feedback or practice in discrimination did not. These findings may contribute to improving awareness of respiratory sensations in asthma patients, and thereby bolster efforts to manage asthma.

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

Symptom perception in pediatric asthma: resistive loading and in vivo assessment compared. [2007] Inaccurate symptom perception contributes to asthma morbidity and mortality in children and adults. Various methods have been used to quantify perceptual accuracy, including psychophysical (resistive loading) approaches, ratings of dyspnea during induced bronchoconstriction, and in vivo monitoring, but it is unclear whether the different methods identify the same individuals as good or poor perceivers. The objectives of the study were as follows: (1) to compare in the same asthmatic children two methods of quantifying perceptual ability: threshold detection of added resistive loads and in vivo symptom perception; and (2) to determine which method best predicts asthma morbidity.

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

The Perception of Asthma Severity in Children. [2018] The ability to perceive the onset and severity of symptoms of worsening asthma is important, not only for initial diagnosis but also for early identification of an asthma exacerbation and prompt management. There are subjective and objective methods for identifying symptoms. Symptom perception is affected by multiple mechanisms, and not all patients can accurately perceive symptoms of airflow limitation. Hyperperceivers will report substantial discomfort in the face of minimal bronchoconstriction, and poor perceivers will report no symptoms even in the presence of severe obstruction. The use of objective measures of airflow limitation is essential for such patients. Regimens for training perception in children and adults have been studied and are available.