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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT04854967
Eligibility Criteria:
Inclusion Criteria:
* Age 40 years or older
* Diagnosis of COPD
* Discharged within the past 3 months after hospitalization for COPD exacerbation, CHF exacerbation and/or Pneumonia and Active prescription for supplemental oxygen within 48 hours of discharge that remains active; or Stable COPD with no chronic resting hypoxemia and an active prescription for supplemental oxygen.
* No inpatient or outpatient exacerbations of COPD within the last 30 days
* Smoked at least 10 pack-years of cigarettes
* Room air resting saturation \>88% on room air
* Spirometry consistent with COPD (FEV1/FVC \< 0.70) and/or evidence of emphysema on CT scan
* Willingness on the part of the participant to stop oxygen if randomized to the intervention
* Ability and willingness to participate in virtual video visits with study staff using VA approved software
* Informed consent for participation
Exclusion Criteria:
* Desaturation during 6MWT \<80% for one minute or more
* Non-COPD lung disease that affects oxygenation or survival (including pulmonary hypertension)
* Prescription of oxygen for alternative condition (e.g. bleed-in with positive airway pressure therapy for obstructive sleep apnea)
* Diagnosis expected to result in death in six months or enrollment in hospice
* Participation in another intervention trial
* Cognitive issues that would preclude participation (dementia, stroke, etc.)
* Residence in skilled nursing facility
* Inability to speak, read, or understand English
* Any safety concerns
* Participants clinical team excludes the participant from recruitment or evaluation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04854967
Study Brief:
Protocol Section:
NCT04854967