Feedback for Asthma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pennsylvania Health System, Philadelphia, PA
Asthma
Feedback - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Feedback will improve 7 primary outcomes and 4 secondary outcomes in patients with Asthma. Measurement will happen over the course of At randomization.

12 months
Asthma Control at 12 months
15 months
Asthma Control at 15 months
18 months
Asthma Control at 18 months
Emergency Department (ED) visits for asthma
asthma-related quality of life
3 months
Asthma Control at 3 months
6 months
Asthma Control at 6 months
9 months
Asthma Control at 9 months
At randomization
Asthma Control at baseline
Month 18
Forced expiratory volume in 1 second (FEV1)
hospitalizations at 18 months
hospitalizations for asthma

Trial Safety

Trial Design

4 Treatment Groups

Clinical intervention
1 of 4
Clinical intervention AND Feedback
1 of 4
Clinical intervention AND Home Visit
1 of 4
Clinical intervention AND Home Visit AND Feedback
1 of 4
Active Control
Experimental Treatment

This trial requires 400 total participants across 4 different treatment groups

This trial involves 4 different treatments. Feedback is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Clinical intervention AND Feedback
Clinical intervention AND Home VisitPatient receives Clinical intervention and Home visits. Care coordination activities occur taking into account the home environment, its social and physical characteristics.
Clinical intervention AND Home Visit AND Feedback
Clinical interventionClinical health navigator, a community health worker, facilitates preparation for, attends, and confirms patients's understanding of an office visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Feedback
2018
N/A
~17830

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 18
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 18 for reporting.

Who is running the study

Principal Investigator
A. A.
Prof. Andrea Apter, Prinicipal Investigator, Professor of Medicine
University of Pennsylvania

Closest Location

University of Pennsylvania Health System - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female or male > 18 years and living in a Philadelphia neighborhood in which at least 20% of households have incomes below the federal poverty level (19104, 19120, 19121, 19122, 19124, 19125, 19131, 19132, 19133, 19134, 19139, 19140, 19141, 19142, 19143, 19144, 19145, 19146, 19153, 19151)
A patient in a participating clinic
Doctor's diagnosis of asthma
Prescribed an inhaled corticosteroid for asthma
Required prednisone or an Emergency Department (ED) visit or hospitalization for asthma within 12 months before enrollment.
Some patients with a diagnosis of asthma and prescribed inhaled corticosteroid may also have mention of Chronic Obstructive Pulmonary Disease (COPD) in their record, particularly if they smoke. Asthma and COPD are both heterogeneous diseases, and may be impossible to distinguish by clinical characteristics.Both COPD and asthma can have evidence of reversible obstruction and also of irreversible obstruction. It is important not to exclude these patients, sometimes called overlap patients as they may benefit from these interventions.

Patient Q&A Section

What are common treatments for asthma?

"The treatments available for asthma are very limited and can typically include avoidance/allergen avoidance, medications, and exercise therapy. However, not all asthma treatments are effective and may cause asthma to worsen. Some of the most effective treatments are the use of inhaled corticosteroids and antihistamines." - Anonymous Online Contributor

Unverified Answer

How many people get asthma a year in the United States?

"Approximately 5.8 million cases are diagnosed annually, making it the third most common reason for a physician visit in the United States and the leading cause of doctor visit costs for patients over age 75 years. Most visits concerned managing symptomatic asthma." - Anonymous Online Contributor

Unverified Answer

Can asthma be cured?

"Asthma is not cured. In many patients, symptoms improve substantially. Effective and effective-enough treatment is possible, and there are certain cases in which asthma can be resolved, but is not curable." - Anonymous Online Contributor

Unverified Answer

What are the signs of asthma?

"Asthmatic adults and children may present with symptoms that are non-specific and can mimic other chronic obstructive lung diseases. In adults, recurrent chest pain, rapid onset and recurrence of wheezing or breathlessness are some of the key characteristics of asthma. Other signs, which are less reliable, include an eosinophilic inflammatory infiltrate in lung biopsy specimens and elevated serum IgE." - Anonymous Online Contributor

Unverified Answer

What is asthma?

"Asthma is the most common chronic inflammatory lung disease. Asthma is also characterized by impaired lung function that often leads to increased mortality rate. Asthma in recent years, disproportionately affects obese individuals, while smokers tend to have less severe symptoms. Asthma is not only a respiratory disease, but a chronic, treatable lung disorder with a life-threatening, acute progression for individuals with severe disease or more severe exacerbations. One percent of the US population may manifest some type of asthma." - Anonymous Online Contributor

Unverified Answer

What causes asthma?

"The environment and lifestyle factors of early life may modify the development of asthma. This modification may result in either the increased likelihood of developing chronic asthma, or, alternatively, in the improved management and control of acute asthma. Lifestyle factors include physical activity, diet, exposure to infectious agents, exposure to air pollutants, and the degree to which the airways are protected from triggers. These factors play an important role only in the development of sensitisation or of asthma. We highlight here environmental factors, namely particulate air pollution, which exert a major influence on the course of asthma and on its response to treatment." - Anonymous Online Contributor

Unverified Answer

Has feedback proven to be more effective than a placebo?

"We found that the intervention group had improved lung functions 1 year after the final intervention while the control group showed a small deterioration. However, due to the statistically relevant small difference between the groups, the effect cannot be said to be significant. It cannot be excluded that the statistical relevance was overestimated by the statistically insignificant small difference between the groups. Because the control group showed a deterioration, while the treatment group improved, it cannot be excluded that a placebo effect played a role. This effect could be either beneficial or harmful, depending on whether the disease is improved or deteriorated. When the intervention group showed an improvement, the effect can be said to be statistically significant, whereas a deterioration cannot." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in feedback for therapeutic use?

"A recent innovation in the delivery of pulmonary rehabilitation has been an increased emphasis on the use of electronic communication by which a clinician can directly send feedback regarding exercise performance to the patient. This allows the patient to continue to receive treatment without having to come into a clinic everyday, and allows clinicians to use rehabilitation strategies they would otherwise have trouble implementing as they need to be tailored to fit the needs of the clinic and the patient. Electronic feedback has been found to be a successful and effective form of pulmonary rehabilitation in outpatient settings. The integration of electronic communication also has a positive impact on clinical outcomes and patient satisfaction. Further research into the benefits of incorporating electronic communication into clinical practice is warranted." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating asthma?

"Several new treatments have been released and have shown promise when tested with a variety of patient populations. The first drug with real advantages over existing treatments is a selective histamine re-uptake inhibitor that blocks the effect of histamine on airway disease, and might have a potential role in the management of asthma in the future. \nIt should be noted that the efficacy of most compounds was not replicated in rigorous, randomized studies for asthma in large multicenter trials. Further work needs to be undertaken to confirm their efficacy and also to elucidate in what situations they are most effective. Moreover, the number of patients needed to achieve a significant clinical impact is probably not too large." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of feedback?

"The most common side effects, occurring in over 50% of patients, were nausea, headache and insomnia. However, all patients tolerated these side effects and some reported improvement." - Anonymous Online Contributor

Unverified Answer

What does feedback usually treat?

"Feedback is a well-accepted methodology to improve quality use of health services by enhancing evidence-based practice practices. Therefore, feedback should be a first option in education of all health workers, especially for trainees." - Anonymous Online Contributor

Unverified Answer

Does feedback improve quality of life for those with asthma?

"An interactive curriculum using standardized patients and standardized patients' reflections, led by an internal medicine and pediatrics resident-led team, reduced LNAA and increased perceptions of QOL among pediatric asthmatics, while only small improvements were seen among adult asthmatics." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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