Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
PELICAN
1 other identifier
interventional
444
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
August 6, 2018
CompletedAugust 6, 2018
November 1, 2017
1.4 years
March 14, 2014
December 30, 2016
November 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to Supplemental O2 Prescription
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
60 days
Secondary Outcomes (7)
PROMIS - Physical Function
60 days
PROMIS - Fatigue
60 days
PROMIS - Emotional Distress - Anxiety
60 days
PROMIS - Sleep Disturbance
60 days
PROMIS - Emotional Distress - Depression
60 days
- +2 more secondary outcomes
Study Arms (3)
Usual care
OTHERWritten education material (basic)
Proactive
EXPERIMENTALWritten 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
EXPERIMENTALWritten education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\]
Interventions
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.
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unable to read and speak English.
- Discharge to home hospice or expected survival less than 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- AlphaNetcollaborator
- Apria Healthcarecollaborator
- COPD Foundationcollaborator
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centercollaborator
- National Jewish Healthcollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- American Association for Respiratory Carecollaborator
Study Sites (6)
Apria Healthcare
Lake Forest, California, 92630, United States
Los Angeles Biomedical Research Institute
Torrance, California, 90502, United States
National Jewish Health
Denver, Colorado, 80206, United States
AlphaNet
Miami, Florida, 33134, United States
COPD Foundation
Miami, Florida, 33134, United States
University of Illinois Hospital
Chicago, Illinois, 60612, United States
Related Publications (1)
Prieto-Centurion V, Holm KE, Casaburi R, Porszasz J, Basu S, Bracken NE, Gallardo R 3rd, Gonzalez V, Illendula SD, Sandhaus RA, Sullivan JL, Walsh LJ, Gerald LB, Krishnan JA. A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2023 Nov;20(11):1561-1570. doi: 10.1513/AnnalsATS.202302-104OC.
PMID: 37683098DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jerry A. Krishnan, MD, PhD
- Organization
- University of Illinois at Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry A Krishnan, MD, PhD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Public Health; Associate Vice Chancellor for Population Health Sciences
Study Record Dates
First Submitted
March 14, 2014
First Posted
March 28, 2014
Study Start
April 1, 2015
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
August 6, 2018
Results First Posted
August 6, 2018
Record last verified: 2017-11