Evaluation of COPD Co-Pilot

HGE Health Care Solutions

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: COPD Co-Pilot

Study type: Observational

Funder types: Industry

Identifiers

NCT02944591

CPV2-2016-S2

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 32 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 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