Evaluation of COPD Co-Pilot

HGE Health Care Solutions, LLC1 site in 1 country23 target enrollmentJanuary 2017

ConditionsCOPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COPD
Sponsor: HGE Health Care Solutions, LLC
Enrollment: 23
Locations: 1
Primary Endpoint: Patient Adoption
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of undertaking this study is to examine the use of COPD Co-PilotTM, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in COPD patients outside of the geographic base of HGE's existing patient population (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to additional geographic sites and to examine whether similar outcome measures are achieved in patients under the supervision of health care providers that are new to the program.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

March 2018

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

HGE Health Care Solutions, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has read, understood and signed an informed consent form prior to enrollment.
•Males or females age ≥35 years old
•Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)
•Must be able to read and understand English and consent for themselves
•Subject is willing and able to use an iPad mini device.

Exclusion Criteria

•Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
•Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
•Subject has any condition that in the opinion of the provider may adversely affect their participation
•Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
•Subject has a planned procedures at time of enrollment that will occur within timeframe of study that will require hospitalization or otherwise adversely affect their ability to participate
•Subject has no cellular coverage at their primary residence
•Subject plans to travel to a location with no cellular coverage for a significant period (\>1 week) during their program participation

Outcomes

Primary Outcomes

Patient Adoption

Time Frame: 6 months

Percentage of potential daily symptom reports completed by patients

Secondary Outcomes

Patient Satisfaction(6 months)
Symptom change detected(6 months)
Clinical responses(6 months)
Medication compliance(6 months)
Emergency department visits(6 months)
Clinic visits(6 months)
Medications(6 months)
Patient reported respiratory symptoms(6 months)
Episode duration(6 months)
Patient profile information(6 months)
Source of inpatient admissions and visits to the Emergency Department (ED)(6 months)
Inpatient Admissions(6 months)
Hospitalization history(6 months)
Readmission rate(6 months)
Length of stay(6 months)
Readmissions(6 months)