NCT02098369

Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers

Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using O2 can prolong life and increase quality of life. Patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (COPD).

Detailed description

The COPD Foundation operates a peer-led telephone-based information line, but its effectiveness in promoting adherence to O2 therapy and patient-centered outcomes is unknown. Our overall hypothesis is that a patient-centered Peer-Led O2 InfoLine for patients and CAregivers (PELICAN) will increase adherence and improve health. We have developed a broad-based collaboration with patients/caregivers, advocacy groups, a national O2 supplier, and others to conduct a 3-arm pragmatic clinical trial, to evaluate the comparative effectiveness of proactive vs. reactive PELICAN interventions vs. usual care on adherence to O2 (primary outcome) and on other patient-centered outcomes (secondary outcomes).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
BEHAVIORAL	Written education material (basic)	Education material on COPD distributed to all participants.
BEHAVIORAL	Additional education material	Additional education material sent to participants in the proactive and reactive arms.
BEHAVIORAL	PELICAN-Proactive	In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy.
BEHAVIORAL	PELICAN-Reactive	Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2014-03-28
• Last updated: 2018-08-06
• Results posted: 2018-08-06

Locations

6 sites across 1 country: United States