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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-10-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care

Written education material (basic)

Group Type OTHER

Written education material (basic)

Intervention Type BEHAVIORAL

Education material on COPD distributed to all participants.

Proactive

Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\]

Group Type EXPERIMENTAL

Written education material (basic)

Intervention Type BEHAVIORAL

Education material on COPD distributed to all participants.

Additional education material

Intervention Type BEHAVIORAL

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

PELICAN-Proactive

Intervention Type 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.

Reactive

Written education material (basic) Additional education material PELICAN-Reactive \[In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)\]

Group Type EXPERIMENTAL

Written education material (basic)

Intervention Type BEHAVIORAL

Education material on COPD distributed to all participants.

Additional education material

Intervention Type BEHAVIORAL

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

PELICAN-Reactive

Intervention Type BEHAVIORAL

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

Interventions

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Written education material (basic)

Education material on COPD distributed to all participants.

Intervention Type BEHAVIORAL

Additional education material

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

Intervention Type 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.

Intervention Type BEHAVIORAL

PELICAN-Reactive

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.