Clinical trial NCT02098369: Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
Official title: Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
Supplemental oxygen
Adherence
Telephonic education
Peer coaching
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: AlphaNet
name: Apria Healthcare
name: COPD Foundation
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: National Jewish Health
name: Patient-Centered Outcomes Research Institute
name: American Association for Respiratory Care
First posted: 2014-03-28
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older.
2. Physician diagnosis of COPD
3. Physician prescription for home O2 for 24hrs/day, 7 days/week
4. Willing to use home O2.
5. Working telephone number.

Exclusion Criteria:

1. Unable to read and speak English.
2. Discharge to home hospice or expected survival less than 6 months.

Primary outcomes:
measure: Adherence to Supplemental O2 Prescription
timeFrame: 60 days
Secondary outcomes:
measure: PROMIS - Physical Function
timeFrame: 60 days
measure: PROMIS - Fatigue
timeFrame: 60 days
measure: PROMIS - Emotional Distress - Anxiety
timeFrame: 60 days
measure: PROMIS - Sleep Disturbance
timeFrame: 60 days
measure: PROMIS - Emotional Distress - Depression
timeFrame: 60 days
measure: PROMIS - Satisfaction With Social Roles and Activities
timeFrame: 60 days
measure: PROMIS - Ability to Participate in Social Roles and Activities
timeFrame: 60 days
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Apria Healthcare
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Miami
country: United States
facility: AlphaNet
state: Florida
city: Miami
country: United States
facility: COPD Foundation
state: Florida
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jerry A Krishnan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: