Remote Monitoring of Respiratory Health

December 6, 2024 updated by: R. Sharon Chinthrajah, Stanford University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Monitoring
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.
Behavioral: Mobile Monitoring
Participants use a smartphone app for self monitoring of respiratory symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS-10 survey
Time Frame: Up to 2 years
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)
Time Frame: Up to 2 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sharon Chinthrajah, MD, Stanford University, Sean N. Parker Center for Allergy and Asthma Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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