Study Results
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View full resultsBasic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2019-02-15
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Asthma education and PEF feedback
Patients receive asthma education and personal Peak expiratory flow (PEF) feedback
PEF Feedback
Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
Asthma education
No PEF feedback arm
Asthma education
General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
Interventions
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PEF Feedback
Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
Asthma education
General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking
* Asthma diagnosis made by a health care provider
Exclusion Criteria
* Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness
* Smoking history of ≥15 pack-years owing to possible undiagnosed COPD
* Moderate or severe cardiac disease (including New York Heart Association stages 4 or 5 congestive heart failure, because dyspnea among patients with severe heart failure is more likely to be attributable to their heart condition than their asthma)
* Dependence on assistance for medication administration
* Uncorrectable visual impairment
60 Years
ALL
No
Sponsors
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Albert Einstein College of Medicine
OTHER
Jacobi Medical Center
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Juan P Wisnivesky
Professor of Medicine and Chief, Division of General Internal Medicine
Principal Investigators
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Juan Wisnivesky, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Albert Einstein College of Medicine/Yeshiva University
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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GCO 15-0667
Identifier Type: -
Identifier Source: org_study_id
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