Remote Monitoring of Respiratory Health

Study Overview
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Brief Summary
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Recently, interest in ways to monitor and care for patients remotely has significantly increased due to concerns for infection control as well as a way to increase access to regular clinic visits that may be limited for socioeconomic and geographic reasons. However, remote care can be limited by a lack of objective data to help guide clinical care. With respect to respiratory disease, caring for patients remotely may be enhanced by the ability of patients to monitor at home such things as vital signs, lung sounds, and lung function by spirometry. Enhanced methods to follow symptoms and track medication compliance may also be beneficial. These enhancements could improve care and quality of life both for persons with acute respiratory illnesses and those with chronic respiratory disease (such as asthma or COPD). The purpose of this study is to develop and study methods for patients to monitor their respiratory health at home and make that data available to medical providers to improve their care.

Official Title
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Remote Monitoring of Respiratory Health

Conditions
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Asthma, Chronic Respiratory Disease, Copd

Intervention / Treatment
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* Device: Mobile Monitoring Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 1 month or older with a diagnosis of chronic respiratory disease (ex. asthma, COPD), an acute respiratory illness or a healthy volunteer able to consent or assent with parental consent Exclusion Criteria: people who do not consent significant cognitive impairment non-English speaking

Ages Eligible for Study
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Minimum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be given access to one or more devices or smartphone/tablet applications. They will then be followed with surveys as well as data from chart review to see how use of one or more elements for remote monitoring may affect their quality of life and overall care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Monitoring<br>Participants will be asked to use a smartphone or tablet application for remote monitoring or respiratory health. They will be followed over time with surveys as well as chart review to assess effects of adding these mobile monitoring elements to their standard care. | Device: Mobile Monitoring Device<br>* App for self monitoring device for respiratory symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS-10 survey | The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. | Up to 2 years | 
| Asthma Control Test (ACT) | Asthma Control Test is a patient self-administered tool for identifying those with poorly controlled asthma. Scores are on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). Sores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital health, mobile monitoring