Evaluation of COPD Co-Pilot

Status unconfirmed

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The purpose of this research study is to investigate the potential benefits of participant use of a smartphone application ("App") called COPD Co-Pilot™. When used by the participant, COPD Co-Pilot™ may provide early detection of worsening COPD symptoms. Early symptom detection may allow the pulmonary providers and nurses to respond with timely medical advice and treatment. The goal for use of COPD Co-Pilot™ is to reduce the frequency and duration of hospitalizations, emergency department visits, and hospital readmissions. The study will also examine the financial impact of the COPD Co-Pilot™ program to determine whether costs of hospital stays, emergency department visits, and hospital readmissions differ when patients are enrolled in COPD Co-Pilot™ than when they are not enrolled. Another purpose of this study is to measure patient satisfaction with use of COPD Co-Pilot™.

Key facts

Study ID: NCT02944591
Run by: HGE Health Care Solutions, LLC
People needed: 32
Starts: 2016-10-01
Expected to finish: 2018-04-05
Last updated by the study team: 2018-03-29

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Subject has had an acute exacerbation of COPD that required hospitalization or ER visit or treatment with systemic steroids and/or antibiotics during the 28 days prior to enrollment.
Subjects who had a COPD exacerbation within 28 days prior to Visit 1 can be rescreened once. Rescreening can occur no earlier than 28 days from the last dose of systemic steroids and/or antibiotics and/or hospitalization, whichever is later
Subject has a COPD exacerbation or respiratory illness during the Run-In period that in the judgment of the investigator requires medical intervention (e.g., treatment with systemic steroids and/or antibiotics and/or hospitalization).
Subjects who had a COPD exacerbation or infection during the Run-In period can be rescreened once. Rescreening can occur no earlier than 28 days from the last dose of systemic steroid and/or antibiotics and/or hospitalization, whichever is later.
Subject is suffering from terminal illness expected to adversely affect survival in the next 12 months
Subject has a history of non-compliance with medical therapies
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 may, in the opinion of the provider, be non-compliant with study schedules or procedures
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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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