Clinical trial NCT03018847: Evaluation of COPD Co-Pilot
Official title: Evaluation of COPD Co-Pilot
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Lead sponsor: HGE Health Care Solutions, LLC
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2017-01-12
Enrollment: 23
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 Medical University of South Carolina Health System. 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 undertaking this study is to examine the use of COPD Co-PilotTM, a COPD disease management program manufactured and operated by HGE Health Care Solutions, LLC, in COPD patients outside of the geographic base of HGE's existing patient population (Philadelphia, PA). The purpose is to demonstrate the feasibility of expanding the program to additional geographic sites and to examine whether similar outcome measures are achieved in patients under the supervision of health care providers that are new to the program.

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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 a cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage
2. Subject is currently known to suffer from or have a history of significant substance abuse within the last 2 years
3. Subject has any condition that in the opinion of the provider may adversely affect their participation
4. Subject is residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
5. 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
6. Subject has no cellular coverage at their primary residence
7. 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: 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
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Tatsiana Beiko, 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.