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Remote Monitoring of Respiratory Health

Primary Purpose

Chronic Respiratory Disease, Asthma, Copd

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Monitoring Device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Respiratory Disease focused on measuring digital health, mobile monitoring

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile Monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2021
Last Updated
November 30, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04739943
Brief Title
Remote Monitoring of Respiratory Health
Official Title
Remote Monitoring of Respiratory Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease, Asthma, Copd
Keywords
digital health, mobile monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile Monitoring Device
Intervention Description
App for self monitoring device for respiratory symptoms
Primary Outcome Measure Information:
Title
PROMIS-10 survey
Description
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.
Time Frame
Up to 2 years
Title
Asthma Control Test (ACT)
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Chinthrajah, MD
Organizational Affiliation
Stanford University, Sean N. Parker Center for Allergy and Asthma Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring of Respiratory Health

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