Skip to main content
OpenTrials
Completed

NCT Number: NCT02098369

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Apria Healthcare, Lake Forest, California, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Written education material (basic)

Behavioral

Education material on COPD distributed to all participants.

Additional education material

Behavioral

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

PELICAN-Proactive

Behavioral

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.

PELICAN-Reactive

Behavioral

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

Primary outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • AlphaNet
  • American Association for Respiratory Care
  • Apria Healthcare
  • COPD Foundation
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • National Jewish Health
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: PELICAN

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.