Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

NCT03300739 | Completed DMC

• 1 other identifier: 2016P002312
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD Exacerbation; Copd

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Oxygen saturation (%)

  Daily for 16 weeks

• Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.

  Weekly for16 weeks

• Physical activity

  Daily for 16 weeks

• Body Mass Index (kg/m^2)

  Baseline (Day 0) and Close-out (16 weeks)

• Quality of life

  Baseline (Day 0) and Close-out (16 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD diagnosis

You may qualify if:

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

You may not qualify if:

• Currently on admission in the hospital, on non-invasive positive airway pressure ventilation
• Visual, hearing or cognitive impairments at the discretion of their physician.
• Currently participating in a COPD telemonitoring program.
• No AT\&T cellular coverage at their primary residence
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ResMed: collaborator

Study Sites (1)

Partners Connected Health

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Agboola, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: October 3, 2017
• Study Start: December 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)