Pulmonary Disease, Chronic ObstructiveNCT02944591
Evaluation of COPD Co-Pilot
An observational study of Pulmonary Disease, Chronic Obstructive, run by HGE Health Care Solutions, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- COPD Co-Pilot
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 5 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
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™.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- COPD Co-Pilot
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD Co-PilotDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Adoption
Percentage of potential daily symptom reports completed by patients
Measured: 6 months
Secondary outcomes (19)
Patient Satisfaction
patient satisfaction questionnaire
Measured: 6 months
Inpatient Admissions
admission records for period prior to study and during study
Measured: 6 months
Emergency department visits
emergency department records for period prior to study and during study
Measured: 6 months
Clinic visits
clinic visits for period prior to study and during study
Measured: 6 months
Patient reported respiratory symptoms
Daily values for breathlessness, sputum quantity, sputum color, sputum consistency, peak flow, temperature over 100 F, cough, wheeze, sore throat, and nasal congestion.
Measured: 6 months
Symptom change detected
Change index (a numeric value) and the categorical level of change that corresponds to the patient's reported symptoms when compared to their baseline. This is recorded for each daily symptom report submitted after completion of the run-in period.
Measured: 6 months
Episode duration
the date when a mild, moderate or significant level of change is first detected for a patient through the date immediately followed by seven consecutive days in which a level of "no change" (i.e. return to baseline) is detected. The total number of days in this period, symptoms reported during this period, and clinical responses communicated to the patient (including any treatments or changes) will be reported for analysis.
Measured: 6 months
Time to clinical responses
Time elapsed between the patient's check-in and the time the response was acknowledged by the patient.
Measured: 6 months
Hospitalization history
hospitalization history reported to Health Assistants by patients during scheduled monthly phone calls. This will be reconciled with admissions data from the site and may include utilization at other institutions.
Measured: 6 months
Medications
list of medications and changes entered by site coordinator, provider, or reported by subjects to Health Assistants during scheduled monthly phone calls.
Measured: 6 months
Patient profile information
This will include, among other variables, medical history, smoking history, spirometry results, oxygen use, and diagnoses of co-morbidities. For a full list of profile data, please see the appendix.
Measured: 6 months
Medication compliance
compliance with newly prescribed treatments as reported by patients during follow up phone calls.
Measured: 6 months
Length of stay
total number of inpatient days per admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient date of birth (DOB), location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. Reported for period prior to study and during study period
Measured: 6 months
Readmissions
The number of inpatient admissions that occur within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis, diagnosis at discharge, and associated costs broken down by category. This will be reported for time prior to study and during study period.
Measured: 6 months
Readmission rate
The rate and percent of inpatient admissions that occur within 30, 60, and 90 days of discharge from a prior admission will be reported for analyses. These records will include date of admission, date of discharge, patient name and medical record number, patient DOB, location, length of stay, attending physician, admission diagnosis and diagnosis at discharge. These will be reported for the period prior to the start of the study through the study period.
Measured: 6 months
Source of inpatient admissions and visits to the Emergency Department (ED)
The source (e.g. from home, from accident, from outpatient clinical, at direction of physician, from ED, etc.) of each and every inpatient admission and emergency department visit will be reported for analyses. These will be reported for the period prior to the enrollment through the study period.
Measured: 6 months
Cost of Care
Costs associated with hospitalizations, emergency department visits, clinic visits, and medications
Measured: 6 months
Historic utilization
hospitalizations, emergency department visits, clinic visits in the 6 months prior to enrollment; and hospitalizations, emergency department visits, clinic visits in the same 6 month period during the prior year
Measured: 6 months
Historic costs
costs associated with hospitalizations, emergency department visits, clinic visits in the 6 months prior to enrollment; and costs associated with hospitalizations, emergency department visits, clinic visits in the same 6 month period during the prior year
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion5 Apr 2018 (estimated)
- Study completion5 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HGE Health Care Solutions, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark T Dransfield, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944591
- Sponsor's protocol ID
- CPV2-2016-S2
- Status last verified
- Mar 2018
- First submitted
- 24 Oct 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26451903Cordova 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.
PubMed 26259074Kim 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.
PubMed 21495839So 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.
PubMed 28848862Remakus, Christopher B., et al.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of COPD Co-Pilot
- ClinicalTrials.gov ID
- NCT02944591
- Acronym / sponsor ID
- CPV2-2016-S2
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HGE Health Care Solutions, LLCIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Oct 2016
- Primary completion
- 5 Apr 2018 (estimated)
- Study completion
- 5 Apr 2018 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- 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).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD Co-PilotThe 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. | Device | – |
Primary outcome
Patient Adoption
Time frame: 6 months
Percentage of potential daily symptom reports completed by patients
19 secondary outcomes
Patient Satisfaction
Time frame: 6 months
Inpatient Admissions
Time frame: 6 months
Emergency department visits
Time frame: 6 months
Clinic visits
Time frame: 6 months
Patient reported respiratory symptoms
Time frame: 6 months
Symptom change detected
Time frame: 6 months
Episode duration
Time frame: 6 months
Time to clinical responses
Time frame: 6 months
Hospitalization history
Time frame: 6 months
Medications
Time frame: 6 months
Patient profile information
Time frame: 6 months
Medication compliance
Time frame: 6 months
Length of stay
Time frame: 6 months
Readmissions
Time frame: 6 months
Readmission rate
Time frame: 6 months
Source of inpatient admissions and visits to the Emergency Department (ED)
Time frame: 6 months
Cost of Care
Time frame: 6 months
Historic utilization
Time frame: 6 months
Historic costs
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 26451903Smith 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.
- Background: PubMed 26259074Cordova 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.
- Background: PubMed 21495839Kim 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.
- Background: PubMed 28848862So 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.
- BackgroundRemakus, Christopher B., et al.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T Dransfield, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by HGE Health Care Solutions, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Adoption (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02944591, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.