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Clinical Trials/NCT03018847
NCT03018847
Unknown
Not Applicable

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

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.

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Registry
clinicaltrials.gov
Start Date
January 2017
End Date
March 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

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)

Study Sites (1)

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