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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
444
Education material on COPD distributed to all participants.
Additional education material sent to participants in the proactive and reactive arms.
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.
Apria Healthcare
Lake Forest, California, United States
Los Angeles Biomedical Research Institute
Torrance, California, United States
National Jewish Health
Denver, Colorado, United States
AlphaNet
Miami, Florida, United States
Adherence to Supplemental O2 Prescription
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
Time frame: 60 days
PROMIS - Physical Function
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
Time frame: 60 days
PROMIS - Fatigue
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
Time frame: 60 days
PROMIS - Emotional Distress - Anxiety
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
Time frame: 60 days
PROMIS - Sleep Disturbance
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
Time frame: 60 days
PROMIS - Emotional Distress - Depression
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
Time frame: 60 days
PROMIS - Satisfaction With Social Roles and Activities
Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)
Time frame: 60 days
PROMIS - Ability to Participate in Social Roles and Activities
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
COPD Foundation
Miami, Florida, United States
University of Illinois Hospital
Chicago, Illinois, United States
Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)
Time frame: 60 days