Evaluation of COPD Co-Pilot
Status: | Active, not recruiting |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 35 - Any |
Updated: | 4/17/2018 |
Start Date: | October 2016 |
End Date: | April 5, 2018 |
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™.
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™.
During the 6-month observational period, subjects will report respiratory symptoms using COPD
Co-Pilot on a daily basis and will receive feedback and clinical recommendations from their
health care provider when their symptoms change from their baseline symptoms. Final clinical
recommendations, medical advice, diagnoses, and treatment are in the full and sole discretion
of the provider.
All subjects will receive current standard of care under the supervision of their health care
provider. No experimental drugs, dosages, or treatment protocols will be administered at any
stage during this trial.
Subjects will receive monthly calls to determine whether any changes to the subject's medical
history, hospitalization history, medications, etc. have occurred so they may be added to the
subject's profile.
At approximately 6 months post enrollment, all subjects will have an in person end of study
visit.
Co-Pilot on a daily basis and will receive feedback and clinical recommendations from their
health care provider when their symptoms change from their baseline symptoms. Final clinical
recommendations, medical advice, diagnoses, and treatment are in the full and sole discretion
of the provider.
All subjects will receive current standard of care under the supervision of their health care
provider. No experimental drugs, dosages, or treatment protocols will be administered at any
stage during this trial.
Subjects will receive monthly calls to determine whether any changes to the subject's medical
history, hospitalization history, medications, etc. have occurred so they may be added to the
subject's profile.
At approximately 6 months post enrollment, all subjects will have an in person end of study
visit.
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 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
2. 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.
3. Subject is suffering from terminal illness expected to adversely affect survival in
the next 12 months
4. Subject has a history of non-compliance with medical therapies
5. Subject has a cognitive impairment (determined by physician) that will make it hard to
follow instructions regarding device usage
6. Subject is currently known to suffer from or have a history of significant substance
abuse within the last 2 years
7. Subject has any condition that in the opinion of the provider may adversely affect
their participation
8. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute
Care facilities
9. 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
10. Subject may, in the opinion of the provider, be non-compliant with study schedules or
procedures
11. Subject has no cellular coverage at their primary residence
12. Subject plans to travel to a location with no cellular coverage for a significant
period (>1 week) during their program participation
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