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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— PELICAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098369
• Other study ID #: PCORI-CE 1304-6490
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2017
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Written education material (basic)
Education material on COPD distributed to all participants.
• Additional education material
Additional education material sent to participants in the proactive and reactive arms.
• 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.
• PELICAN-Reactive
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.

Locations

Country	Name	City	State
United States	University of Illinois Hospital	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Apria Healthcare	Lake Forest	California
United States	AlphaNet	Miami	Florida
United States	COPD Foundation	Miami	Florida
United States	Los Angeles Biomedical Research Institute	Torrance	California

Sponsors (8)

Lead Sponsor	Collaborator
University of Illinois at Chicago	AlphaNet, American Association for Respiratory Care, Apria Healthcare, COPD Foundation, Los Angeles Biomedical Research Institute, National Jewish Health, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PROMIS - Physical Function	Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)	60 days
Secondary	PROMIS - Fatigue	Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)	60 days
Secondary	PROMIS - Emotional Distress - Anxiety	Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)	60 days
Secondary	PROMIS - Sleep Disturbance	Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)	60 days
Secondary	PROMIS - Emotional Distress - Depression	Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)	60 days
Secondary	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.)	60 days
Secondary	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.)	60 days

External Links

•   Patient-Centered Outcomes Research Institute (PCORI): Funding Award details