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

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ClinicalTrials.gov Identifier: NCT02098369
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
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
Information provided by (Responsible Party):
Jerry Krishnan, 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Written education material (basic) Behavioral: Additional education material Behavioral: PELICAN-Proactive Behavioral: PELICAN-Reactive Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Usual care
Written education material (basic)
Behavioral: Written education material (basic)
Education material on COPD distributed to all participants.

Experimental: 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)]
Behavioral: Written education material (basic)
Education material on COPD distributed to all participants.

Behavioral: Additional education material
Additional education material sent to participants in the proactive and reactive arms.

Behavioral: PELICAN-Proactive
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.

Experimental: 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)]
Behavioral: Written education material (basic)
Education material on COPD distributed to all participants.

Behavioral: Additional education material
Additional education material sent to participants in the proactive and reactive arms.

Behavioral: PELICAN-Reactive
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.




Primary Outcome Measures :
  1. Adherence to Supplemental O2 Prescription [ Time Frame: 60 days ]
    Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day


Secondary Outcome Measures :
  1. PROMIS - Physical Function [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)

  2. PROMIS - Fatigue [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)

  3. PROMIS - Emotional Distress - Anxiety [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)

  4. PROMIS - Sleep Disturbance [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)

  5. PROMIS - Emotional Distress - Depression [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)

  6. PROMIS - Satisfaction With Social Roles and Activities [ Time Frame: 60 days ]
    Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)

  7. PROMIS - Ability to Participate in Social Roles and Activities [ Time Frame: 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.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098369


Locations
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United States, California
Apria Healthcare
Lake Forest, California, United States, 92630
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
AlphaNet
Miami, Florida, United States, 33134
COPD Foundation
Miami, Florida, United States, 33134
United States, Illinois
University of Illinois Hospital
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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
Investigators
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Principal Investigator: Jerry A Krishnan, MD, PhD University of Illinois at Chicago
Additional Information:
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Responsible Party: Jerry Krishnan, Professor of Medicine and Public Health; Associate Vice Chancellor for Population Health Sciences, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02098369    
Other Study ID Numbers: PCORI-CE 1304-6490
First Posted: March 28, 2014    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018
Last Verified: November 2017
Keywords provided by Jerry Krishnan, University of Illinois at Chicago:
Chronic obstructive pulmonary disease (COPD)
Supplemental oxygen
Adherence
Telephonic education
Peer coaching
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases