Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02341157
Eligibility Criteria:
Inclusion Criteria:
1. Have a diagnosis of COPD at or prior to hospitalization.
2. Be hospitalized for one of the following reasons:
* COPD exacerbation
* COPD
* COPD with pneumonia
3. 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).
4. 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.
5. Be willing to perform daily objective and subjective measurements using the PikoLogic® device and maintain daily utilization for 1 year following discharge.
6. The subject is fluent in English for reading and writing.
7. The subject provides written informed consent for the trial.
Exclusion Criteria:
1. Has a current diagnosis of any disease with chronic airflow obstruction other than COPD.
2. Is unwilling to use the PikoLogic® and unwilling to maintain a written record of hospitalization for 1 year.
3. Lives in a neighborhood with poor or no cellular coverage.
4. Is currently homeless or in jeopardy of being homeless during the 1 year study period.
5. Does not have a means to be transported to the follow up study visits.
6. Cannot be contacted easily.
7. Discharges against medical advice.
8. In hospice within one year prior to admission.
9. Is associated with the administration of the study. No family member of the investigational study staff may participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02341157
Study Brief:
Protocol Section:
NCT02341157