COPDICENCT02341157
ICE COPD PikoLogic® Cohort Study.Implementation, Compliance, and Effectiveness of Integrating the PikoLogic®
An observational study of COPD, run by University of Louisville.
Trial summary
This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to the current disease management COPD discharge protocol subsequent to an admission for COPD exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Have a diagnosis of COPD at or prior to hospitalization.
Who may be able to join
- Have a diagnosis of COPD at or prior to hospitalization.
- Be hospitalized for one of the following reasons:
- COPD exacerbation
- COPD
- COPD with pneumonia
- Be an ex-smoker or current smoker with a smoking history of ≥ 10 pack years (i.e., 1 pack [20 cigarettes] per day for 10 years).
Show all 10Show fewer
- Be judged by the investigator to be in stable health (except for COPD variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this study.
- Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
- The subject is fluent in English for reading and writing.
- The subject provides written informed consent for the trial.
Who cannot join
- Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
- Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
- Lives in a neighborhood with poor or no cellular coverage.
- Is currently homeless or in jeopardy of being homeless during the 1 year study period.
- Does not have a means to be transported to the follow up study visits.
- Cannot be contacted easily.
Show all 9Show fewer
- Discharges against medical advice.
- In hospice within one year prior to admission.
- Is associated with the administration of the study. No family member of the investigational study staff may participate in this study.
About this study
Official title: Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® Into Disease Management Discharge Care for Patients With COPD Exacerbation: A Prospective Cohort Study.
This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to the current disease management COPD discharge protocol subsequent to an admission for COPD exacerbation.
Read the detailed description
Candidate subjects participating in the cohort study will receive training by the clinical research associate (CRA) on the use of PikoLogic® for home disease management prior to discharge from the hospital. The CRA will also confirm COPD discharge education was completed by a discharge coordinator and the patient understood the instructions. The CRA will review "seek medical care if:" and "seek immediate medical care if:" instructions at discharge. The discharge CRA will also evaluate subjects for their ability to use the PikoLogic® correctly and will score the patient using an objective and subjective measurement tool. A modified Discharge Knowledge Assessment Tool© will be utilized.1 Objective measurements will include training time and patient compliance with PikoLogic® prior to discharge. Subjective data scores and objective measurements will be utilized for program implementation evaluation.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
: patient diary compliance at 30 and 365 days post-discharge.
To evaluate short term clinical implementation and patient compliance of a COPD PikoLogic® discharge action plan for COPD patients to assist in home care self-monitoring.
Measured: 30 days and 365 day reviews
Secondary outcomes (3)
Time to first severe exacerbation, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Measured: 30 Days
Number of severe exacerbations, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Measured: 30 and 365 Days
Cost of care, defined as patient healthcare resource utilization and hospital charges if readmission occurs, in the 1 year (52 weeks) following 30 days from hospital discharge for treatment of COPD exacerbation.
Measured: 30 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: Principal Investigator left the University of Louisville.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- nSpire Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Rodney J Folz, MD, PhD, Study director, University of LouisvilleHiram Rivas-Perez, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341157
- Sponsor's protocol ID
- NSH 002-00
- Acronym
- ICE
- Status last verified
- Jan 2015
- First submitted
- 18 Dec 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation, Compliance, and Effectiveness of Integrating the PikoLogic® Into Disease Management Discharge Care for Patients With COPD Exacerbation: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT02341157
- Acronym / sponsor ID
- ICE / NSH 002-00
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the University of Louisville.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- nSpire Health, Inc.
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Jan 2015 (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.
This is a two-step observational cohort study evaluating the impact of adding PikoLogic® to the current disease management COPD discharge protocol subsequent to an admission for COPD exacerbation.
Detailed description
Candidate subjects participating in the cohort study will receive training by the clinical research associate (CRA) on the use of PikoLogic® for home disease management prior to discharge from the hospital. The CRA will also confirm COPD discharge education was completed by a discharge coordinator and the patient understood the instructions. The CRA will review "seek medical care if:" and "seek immediate medical care if:" instructions at discharge. The discharge CRA will also evaluate subjects for their ability to use the PikoLogic® correctly and will score the patient using an objective and subjective measurement tool. A modified Discharge Knowledge Assessment Tool© will be utilized.1 Objective measurements will include training time and patient compliance with PikoLogic® prior to discharge. Subjective data scores and objective measurements will be utilized for program implementation evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Have a diagnosis of COPD at or prior to hospitalization.
Key inclusion criteria (10 listed)
- Have a diagnosis of COPD at or prior to hospitalization.
- Be hospitalized for one of the following reasons:
- Be an ex-smoker or current smoker with a smoking history of ≥ 10 pack years (i.e., 1 pack [20 cigarettes] per day for 10 years).
- Be judged by the investigator to be in stable health (except for COPD variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this study.
- Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
Key exclusion criteria (9 listed)
- Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
- Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
- Lives in a neighborhood with poor or no cellular coverage.
- Is currently homeless or in jeopardy of being homeless during the 1 year study period.
- Does not have a means to be transported to the follow up study visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
: patient diary compliance at 30 and 365 days post-discharge.
Time frame: 30 days and 365 day reviews
To evaluate short term clinical implementation and patient compliance of a COPD PikoLogic® discharge action plan for COPD patients to assist in home care self-monitoring.
3 secondary outcomes
Time to first severe exacerbation, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Time frame: 30 Days
Number of severe exacerbations, as defined by an event requiring hospitalization or evaluation in the emergency department 30 days to 1 year after enrollment.
Time frame: 30 and 365 Days
Cost of care, defined as patient healthcare resource utilization and hospital charges if readmission occurs, in the 1 year (52 weeks) following 30 days from hospital discharge for treatment of COPD exacerbation.
Time frame: 30 and 365 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Related trials for COPD
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
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.
Rodney J Folz, MD, PhD study director
University of Louisville
Hiram Rivas-Perez, MD principal investigator
University of Louisville
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University of Louisville.
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 10 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 diary compliance at 30 and 365 days post-discharge. (time frame: 30 days and 365 day reviews). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.