Clinical trial NCT02944591: Evaluation of COPD Co-Pilot
Official title: Evaluation of COPD Co-Pilot
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: HGE Health Care Solutions, LLC
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2016-10-26
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects shall be recruited from the pool of patients at the investigative site that have been diagnosed with moderate to severe COPD.

The study is planned to enroll 100 subjects. The study will be conducted at one investigative site in the United States, the University of Alabama at Birmingham. Recruitment will stop when 100 subjects are enrolled. There will be no replacement for dropouts. Recruitment is planned to last approximately 6 months.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Adoption
timeFrame: 6 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
measure: Inpatient Admissions
timeFrame: 6 months
measure: Emergency department visits
timeFrame: 6 months
measure: Clinic visits
timeFrame: 6 months
measure: Patient reported respiratory symptoms
timeFrame: 6 months
measure: Symptom change detected
timeFrame: 6 months
measure: Episode duration
timeFrame: 6 months
measure: Time to clinical responses
timeFrame: 6 months
measure: Hospitalization history
timeFrame: 6 months
measure: Medications
timeFrame: 6 months
measure: Patient profile information
timeFrame: 6 months
measure: Medication compliance
timeFrame: 6 months
measure: Length of stay
timeFrame: 6 months
measure: Readmissions
timeFrame: 6 months
measure: Readmission rate
timeFrame: 6 months
measure: Source of inpatient admissions and visits to the Emergency Department (ED)
timeFrame: 6 months
measure: Cost of Care
timeFrame: 6 months
measure: Historic utilization
timeFrame: 6 months
measure: Historic costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Mark T Dransfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith HS, Criner AJ, Fehrle D, Grabianowski CL, Jacobs MR, Criner GJ. Use of a SmartPhone/Tablet-Based Bidirectional Telemedicine Disease Management Program Facilitates Early Detection and Treatment of COPD Exacerbation Symptoms. Telemed J E Health. 2016 May;22(5):395-9. doi: 10.1089/tmj.2015.0135. Epub 2015 Oct 9.
citation: Cordova FC, Ciccolella D, Grabianowski C, Gaughan J, Brennan K, Goldstein F, Jacobs MR, Criner GJ. A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial. Telemed J E Health. 2016 Feb;22(2):114-122. doi: 10.1089/tmj.2015.0035. Epub 2015 Aug 10.
citation: Kim V, Garfield JL, Grabianowski CL, Krahnke JS, Gaughan JP, Jacobs MR, Criner GJ. The effect of chronic sputum production on respiratory symptoms in severe COPD. COPD. 2011 Apr;8(2):114-20. doi: 10.3109/15412555.2011.558546.
citation: So JY, Lastra AC, Zhao H, Marchetti N, Criner GJ. Daily Peak Expiratory Flow Rate and Disease Instability in Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2015 Nov 11;3(1):398-405. doi: 10.15326/jcopdf.3.1.2015.0142.
citation: Remakus, Christopher B., et al.