Evaluation of COPD Co-Pilot

HGE Health Care Solutions

Status: Unknown

Conditions: COPD

Treatments: Device: COPD Co-Pilot

Study type: Observational

Funder types: Industry

Identifiers

NCT03018847

CPV2-2016-S1

Details and patient eligibility

About

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.

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Enrollment: 23 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subject has a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
2. Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
3. Subject has any condition that in the opinion of the provider may adversely affect their participation
4. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
5. 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
6. Subject has no cellular coverage at their primary residence
7. Subject plans to travel to a location with no cellular coverage for a significant period (>1 week) during their program participation