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

Study Overview
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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).

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).

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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: Written education material (basic)
* Behavioral: Additional education material
* Behavioral: PELICAN-Proactive
* Behavioral: PELICAN-Reactive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual care<br>Written education material (basic) | Behavioral: Written education material (basic)<br>* Education material on COPD distributed to all participants.<br>|
| Experimental: Proactive<br>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)<br>* Education material on COPD distributed to all participants.<br>Behavioral: Additional education material<br>* Additional education material sent to participants in the proactive and reactive arms.<br>Behavioral: PELICAN-Proactive<br>* 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.<br>|
| Experimental: Reactive<br>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)<br>* Education material on COPD distributed to all participants.<br>Behavioral: Additional education material<br>* Additional education material sent to participants in the proactive and reactive arms.<br>Behavioral: PELICAN-Reactive<br>* Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS - Physical Function | Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.) | 60 days | 
| PROMIS - Fatigue | Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.) | 60 days | 
| 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 | 
| PROMIS - Sleep Disturbance | Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.) | 60 days | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching