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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT05661435
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD
2. Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia.
3. Patient able and willing to provide informed consent.
4. Patient can follow study procedures, including instructions for self-placement and operation of device
a. Patient has experience using a smartphone
5. Accessible by telehealth/telephone upon discharge
6. Patient is able and willing to return to study site for study follow-up visits as necessary
Exclusion Criteria:
1. Patient unable or unwilling to provide informed consent
2. Diagnosis of COPD is uncertain
3. Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility)
4. Patient with end-stage medical condition with expected survival no more than 3 months
5. History of adverse reaction or allergy to TegaDerm®
6. Inaccessible by telehealth/telephone post discharge
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT05661435
Study Brief:
Protocol Section:
NCT05661435