Remote Monitoring of Respiratory Health

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04739943
Collaborator
(none)
200
1
1
58.1
3.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Mobile Monitoring Device
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Remote Monitoring of Respiratory Health
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. PROMIS-10 survey [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.

  2. Asthma Control Test (ACT) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Sharon Chinthrajah, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
R. Sharon Chinthrajah, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT04739943
Other Study ID Numbers:
  • 56494
First Posted:
Feb 5, 2021
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by R. Sharon Chinthrajah, Associate Professor of Medicine, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2021