Remote Monitoring of Respiratory Health

Asthma Clinical Trial

Official title:

Remote Monitoring of Respiratory Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04739943
• Other study ID #: 56494
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Respiratory Disease
• Copd
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Device:
• Mobile Monitoring Device
App for self monitoring device for respiratory symptoms

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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