Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Behavioral: Written education material (basic)Behavioral: Additional education materialBehavioral: PELICAN-ReactiveBehavioral: PELICAN-Proactive
- Registration Number
- NCT02098369
- Lead Sponsor
- University of Illinois at Chicago
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
- Age 18 years or older.
- Physician diagnosis of COPD
- Physician prescription for home O2 for 24hrs/day, 7 days/week
- Willing to use home O2.
- Working telephone number.
- Unable to read and speak English.
- Discharge to home hospice or expected survival less than 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reactive Written education material (basic) Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\] Reactive Additional education material Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\] Proactive Additional education material Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\] Proactive Written education material (basic) Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\] Reactive PELICAN-Reactive Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\] Usual care Written education material (basic) Written education material (basic) Proactive PELICAN-Proactive Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\]
- Primary Outcome Measures
Name Time Method Adherence to Supplemental O2 Prescription 60 days Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
- Secondary Outcome Measures
Name Time Method PROMIS - Satisfaction With Social Roles and Activities 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)
PROMIS - Physical Function 60 days Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
PROMIS - Fatigue 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
PROMIS - Emotional Distress - Anxiety 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
PROMIS - Sleep Disturbance 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
PROMIS - Emotional Distress - Depression 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
PROMIS - Ability to Participate in Social Roles and Activities 60 days Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)
Trial Locations
- Locations (6)
Apria Healthcare
🇺🇸Lake Forest, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Illinois Hospital
🇺🇸Chicago, Illinois, United States
AlphaNet
🇺🇸Miami, Florida, United States
COPD Foundation
🇺🇸Miami, Florida, United States
Los Angeles Biomedical Research Institute
🇺🇸Torrance, California, United States