Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Copd Clinical Trial

Official title:

Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300739
• Other study ID #: 2016P002312
• Status: Completed
• Start date: December 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

Description:

The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days.

2. Sufficient understanding of the English language to be able to read and understand study procedures.

Exclusion Criteria:

1. Currently on admission in the hospital, on non-invasive positive airway pressure ventilation

2. Visual, hearing or cognitive impairments at the discretion of their physician.

3. Currently participating in a COPD telemonitoring program.

4. No AT&T cellular coverage at their primary residence

5. Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.

Related Conditions & MeSH terms

• Copd
• COPD Exacerbation
• Disease Progression

Locations

Country	Name	City	State
United States	Partners Connected Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate (breaths per minute)	Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.	Daily, 16 weeks
Secondary	Oxygen saturation (%)	Collected via pulse oximeter.	Daily for 16 weeks
Secondary	Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.	Collected via spirometer	Weekly for16 weeks
Secondary	Physical activity	Collected via step counts	Daily for 16 weeks
Secondary	Body Mass Index (kg/m^2)	Weight and height will be combined to report BMI	Baseline (Day 0) and Close-out (16 weeks)
Secondary	Quality of life	Collected via SF-12 questionnaire	Baseline (Day 0) and Close-out (16 weeks)
Secondary	Depression	Collected via PHQ-8 questionnaire	Monthly for 16 weeks
Secondary	Anxiety	Collected via GAD-7 questionnaire	Baseline (Day 0) and Close-out (16 weeks)
Secondary	COPD symptom assessment	Collected via CAT questionnaire	Weekly for 16 weeks
Secondary	Functional impairment due to dyspnea	Collected via mMRC dyspnea scale	Weekly for 16 weeks
Secondary	Study device usability	Collected via usability questionnaire	Close-out (16 week)
Secondary	Medical treatment	Collected via electronic health record	Baseline (Day 0) and Close-out (16 weeks)
Secondary	Hospitalization records	Collected via electronic health record	Baseline (Day 0) and Close-out (16 weeks)