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出境医 / 临床实验 / CareCOPD - COPD Home Monitoring Study

CareCOPD - COPD Home Monitoring Study

Study Description
Brief Summary:
This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Device: CareCOPD Platform

Detailed Description:
The study goals are to demonstrate early validation of objective home-monitoring of COPD patients using CareCOPD mature devices, paving way for follow-up work of care integration and larger studies. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Moderate-Severe COPD
COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled
 Device: CareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of AECOPD [ Time Frame: 6 months ]
    Percentage of AECOPDs detected by CareCOPD platform


Secondary Outcome Measures :
  1. Average number of days before AECOPD detection [ Time Frame: 6 months ]
  2. False positivity rate [ Time Frame: 6 months ]
    False positivity rate in the detection of AECOPD


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD primarily affects and has adverse events for adults over the age of 40 based on prior COPD literature. Further, this study is observational, to study correlations between CareCOPD platform collected data and AECOPD. AECOPD is more frequent in older adults and will provide more data for the limited pilot study. Therefore, subjects in the study will exclusively be 40 years of age and older. There is no upper limit on age. As the pilot study expands to include interventions from the CareCOPD platform, the age range may be modified to include all subjects having COPD.
Criteria

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for enrollment as study participants:

  • Males and females over the age of 40 years.
  • physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
  • Using rescue medications at home delivered by a metered-dose inhaler or MDI.
  • Speak, read, and understand English.
  • Able to understand study requirements and comply with study procedures.
  • Ability to operate a smartphone or tablet (for questionnaire and symptoms input).

Exclusion Criteria:

Subjects who meet any of these criteria are not eligible for enrollment as study participants:

  • Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
  • Physically disabled such that they are incapable of using metered-dose inhalers.
  • Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.
  • Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
  • Continuous home Oxygen use for greater than 16 hours/day.
  • Inability or unwillingness of the participant to give written informed consent.
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
Contacts and Locations

Contacts
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Contact: Rajoshi Biswas, Ph.D. 8325383042 rajoshi@cognitalabs.com

Locations
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United States, California
Ventura County Medical Center Recruiting
Ventura, California, United States, 93003
Contact: Chris Landon, MD    805-652-6075    chris.landon@ventura.org   
Sponsors and Collaborators
Cognita Labs LLC
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date November 9, 2020
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2021) 		Percentage of AECOPD [ Time Frame: 6 months ]
Percentage of AECOPDs detected by CareCOPD platform
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 2, 2021)
  • Average number of days before AECOPD detection [ Time Frame: 6 months ]
  • False positivity rate [ Time Frame: 6 months ]
    False positivity rate in the detection of AECOPD
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CareCOPD - COPD Home Monitoring Study
Official Title CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
Brief Summary This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.
Detailed Description The study goals are to demonstrate early validation of objective home-monitoring of COPD patients using CareCOPD mature devices, paving way for follow-up work of care integration and larger studies. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population COPD primarily affects and has adverse events for adults over the age of 40 based on prior COPD literature. Further, this study is observational, to study correlations between CareCOPD platform collected data and AECOPD. AECOPD is more frequent in older adults and will provide more data for the limited pilot study. Therefore, subjects in the study will exclusively be 40 years of age and older. There is no upper limit on age. As the pilot study expands to include interventions from the CareCOPD platform, the age range may be modified to include all subjects having COPD.
Condition Chronic Obstructive Pulmonary Disease
Intervention Device: CareCOPD Platform
The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
Study Groups/Cohorts Moderate-Severe COPD
COPD patients diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled
Intervention: Device: CareCOPD Platform
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2021) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for enrollment as study participants:

  • Males and females over the age of 40 years.
  • physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
  • Using rescue medications at home delivered by a metered-dose inhaler or MDI.
  • Speak, read, and understand English.
  • Able to understand study requirements and comply with study procedures.
  • Ability to operate a smartphone or tablet (for questionnaire and symptoms input).

Exclusion Criteria:

Subjects who meet any of these criteria are not eligible for enrollment as study participants:

  • Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
  • Physically disabled such that they are incapable of using metered-dose inhalers.
  • Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.
  • Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
  • Continuous home Oxygen use for greater than 16 hours/day.
  • Inability or unwillingness of the participant to give written informed consent.
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rajoshi Biswas, Ph.D. 8325383042 rajoshi@cognitalabs.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04918095
Other Study ID Numbers CareCOPD20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cognita Labs LLC
Study Sponsor Cognita Labs LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Cognita Labs LLC
Verification Date June 2021