Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT04854967
Brief Summary:
The investigators want to decrease inappropriate oxygen use for patients with COPD. The investigators are testing a new program that will stop oxygen prescriptions for patients that no longer need it and will instead provide them with training in skills that have been shown to help patients breathe better. Participants will be randomly assigned to receive the intervention program or usual care. After 12 weeks the investigators will determine if the program helped stop unnecessary oxygen prescription. The investigators will also determine if health status, distance walked during six minutes, and symptoms of breathlessness after walking are different between participants who received the program and those who did not. The investigators will meet with participating patients and their providers after the study is complete to find out how they feel about this program and if it would be possible to put this change into practice.
Detailed Description:
The purpose of this pilot study is to test an intervention designed to decrease inappropriate oxygen use for patients with COPD. Participants will be randomized to usual care vs. an oxygen de-implementation intervention. Patients assigned to the oxygen de-implementation intervention group will have their active oxygen prescription discontinued, be educated on pursed lip breathing and receive inhaler training. A follow-up assessment will occur at 12 weeks. The primary outcome at 12 weeks will be discontinuation of oxygen. Secondary outcomes include health status as measured by the Clinical COPD Questionnaire (CCQ), tele-six minute walk test (6MWT) distance, and Borg dyspnea scale assessed after the tele-6MWT. Among the intervention group, the investigators will also assess acceptability and feasibility of the intervention for patient participants and their providers.
Recruitment was expected to begin in November 2021 but was delayed due to the COVID-19 Omicron outbreak. Recruitment officially began on April 18, 2022.
Study:
NCT04854967
Study Brief:
Protocol Section:
NCT04854967