Evaluation of COPD Co-Pilot

NCT02944591 | Unknown

• 1 other identifier: CPV2-2016-S2
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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™.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Patient Adoption

  Percentage of potential daily symptom reports completed by patients

  6 months

Secondary Outcomes (19)

• Patient Satisfaction

  6 months

• Inpatient Admissions

  6 months

• Emergency department visits

  6 months

• Clinic visits

  6 months

• Patient reported respiratory symptoms

  6 months

Interventions

COPD Co-Pilot DEVICE

The COPD Co-PilotTM is a smartphone application for symptom reporting supported by a Call Center staffed with pulmonary nurses and Health Assistants who are trained to support patients with COPD. The call center staff are employees and subcontractors of the company that makes the COPD Co-PilotTM, HGE. It is located on the Campus of Temple University in Philadelphia Pennsylvania.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Subject may, in the opinion of the provider, be non-compliant with study schedules or procedures
• Subject has no cellular coverage at their primary residence
• Subject plans to travel to a location with no cellular coverage for a significant period (\>1 week) during their program participation

Sponsors & Collaborators

• HGE Health Care Solutions, LLC: lead
• PneumRx, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (5)

• 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.

  PMID: 26451903 BACKGROUND

• 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.

  PMID: 26259074 BACKGROUND

• 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.

  PMID: 21495839 BACKGROUND

• 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.

  PMID: 28848862 BACKGROUND

• Remakus, Christopher B., et al.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark T Dransfield, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)