Evaluation of COPD Co-Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- HGE Health Care Solutions, LLC
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Patient Adoption
- Last Updated
- 8 years ago
Overview
Brief Summary
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™.
Detailed Description
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.
Investigators
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 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
Outcomes
Primary Outcomes
Patient Adoption
Time Frame: 6 months
Percentage of potential daily symptom reports completed by patients
Secondary Outcomes
- Patient Satisfaction(6 months)
- Inpatient Admissions(6 months)
- Emergency department visits(6 months)
- Clinic visits(6 months)
- Medication compliance(6 months)
- Patient reported respiratory symptoms(6 months)
- Symptom change detected(6 months)
- Episode duration(6 months)
- Time to clinical responses(6 months)
- Hospitalization history(6 months)
- Medications(6 months)
- Patient profile information(6 months)
- Length of stay(6 months)
- Readmissions(6 months)
- Readmission rate(6 months)
- Source of inpatient admissions and visits to the Emergency Department (ED)(6 months)
- Cost of Care(6 months)
- Historic utilization(6 months)
- Historic costs(6 months)