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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Written education material (basic)
Additional education material
PELICAN-Proactive
PELICAN-Reactive
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Apria Healthcare
  • Los Angeles Biomedical Research Institute
  • National Jewish Health
  • AlphaNet
  • COPD Foundation
  • University of Illinois Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Usual care

Proactive

Reactive

Arm Description

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)]

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)]

Outcomes

Primary Outcome Measures

Adherence to Supplemental O2 Prescription
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day

Secondary Outcome Measures

PROMIS - Physical Function
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
PROMIS - Fatigue
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
PROMIS - Emotional Distress - Anxiety
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
PROMIS - Sleep Disturbance
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
PROMIS - Emotional Distress - Depression
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
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.)
PROMIS - Ability to Participate in Social Roles and Activities
Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)

Full Information

First Posted
March 14, 2014
Last Updated
November 6, 2017
Sponsor
University of Illinois at Chicago
Collaborators
AlphaNet, Apria Healthcare, COPD Foundation, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, National Jewish Health, Patient-Centered Outcomes Research Institute, American Association for Respiratory Care
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1. Study Identification

Unique Protocol Identification Number
NCT02098369
Brief Title
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
Acronym
PELICAN
Official Title
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
AlphaNet, Apria Healthcare, COPD Foundation, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, National Jewish Health, Patient-Centered Outcomes Research Institute, American Association for Respiratory Care

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Other
Arm Description
Written education material (basic)
Arm Title
Proactive
Arm Type
Experimental
Arm Description
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)]
Arm Title
Reactive
Arm Type
Experimental
Arm Description
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)]
Intervention Type
Behavioral
Intervention Name(s)
Written education material (basic)
Intervention Description
Education material on COPD distributed to all participants.
Intervention Type
Behavioral
Intervention Name(s)
Additional education material
Intervention Description
Additional education material sent to participants in the proactive and reactive arms.
Intervention Type
Behavioral
Intervention Name(s)
PELICAN-Proactive
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PELICAN-Reactive
Intervention Description
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
Primary Outcome Measure Information:
Title
Adherence to Supplemental O2 Prescription
Description
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
Time Frame
60 days
Secondary Outcome Measure Information:
Title
PROMIS - Physical Function
Description
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
Time Frame
60 days
Title
PROMIS - Fatigue
Description
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
Time Frame
60 days
Title
PROMIS - Emotional Distress - Anxiety
Description
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
Time Frame
60 days
Title
PROMIS - Sleep Disturbance
Description
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
Time Frame
60 days
Title
PROMIS - Emotional Distress - Depression
Description
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
Time Frame
60 days
Title
PROMIS - Satisfaction With Social Roles and Activities
Description
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
Title
PROMIS - Ability to Participate in Social Roles and Activities
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Unable to read and speak English. Discharge to home hospice or expected survival less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry A Krishnan, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Apria Healthcare
City
Lake Forest
State/Province
California
ZIP/Postal Code
92630
Country
United States
Facility Name
Los Angeles Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
AlphaNet
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
COPD Foundation
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
University of Illinois Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.pcori.org/research-results/2013/comparative-effectiveness-peer-led-supplemental-o2-infoline-patients-and
Description
Patient-Centered Outcomes Research Institute (PCORI): Funding Award details

Learn more about this trial

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

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