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| Name | Class |
|---|---|
| AlphaNet | UNKNOWN |
| Apria Healthcare | UNKNOWN |
| COPD Foundation | OTHER |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Other | Written education material (basic) |
|
| Proactive | Experimental | 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)] |
|
| Reactive | Experimental | 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)] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written education material (basic) | Behavioral | Education material on COPD distributed to all participants. |
|
| 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 |
| 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry A Krishnan, MD, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apria Healthcare | Lake Forest | California | 92630 | United States | ||
| Los Angeles Biomedical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37683098 | Derived | Prieto-Centurion V, Holm KE, Casaburi R, Porszasz J, Basu S, Bracken NE, Gallardo R 3rd, Gonzalez V, Illendula SD, Sandhaus RA, Sullivan JL, Walsh LJ, Gerald LB, Krishnan JA. A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2023 Nov;20(11):1561-1570. doi: 10.1513/AnnalsATS.202302-104OC. |
| Label | URL |
|---|---|
| Patient-Centered Outcomes Research Institute (PCORI): Funding Award details | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Written education material (basic) Written education material (basic): Education material on COPD distributed to all participants. |
| FG001 | 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)] 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| National Jewish Health | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| American Association for Respiratory Care | OTHER |
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| 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. |
|
| 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 |
| Torrance |
| California |
| 90502 |
| United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| AlphaNet | Miami | Florida | 33134 | United States |
| COPD Foundation | Miami | Florida | 33134 | United States |
| University of Illinois Hospital | Chicago | Illinois | 60612 | United States |
| FG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Written education material (basic) Written education material (basic): Education material on COPD distributed to all participants. |
| BG001 | 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)] 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. |
| BG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All participants with evaluable data for oxygen use across all equipment. | Posted | Count of Participants | Participants | No | 60 days |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | PROMIS - Physical Function | Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 60 days |
| |||||||||||||||||||||||||||||||||
| Secondary | PROMIS - Fatigue | Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 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.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 60 days |
| |||||||||||||||||||||||||||||||||
| Secondary | PROMIS - Sleep Disturbance | Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 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.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 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.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 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.) | The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures. | Posted | Mean | Standard Error | T-score | 60 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Written education material (basic) Written education material (basic): Education material on COPD distributed to all participants. | 0 | 142 | 0 | 142 | ||
| EG001 | 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)] 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. | 0 | 154 | 0 | 154 | ||
| EG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. | 0 | 148 | 0 | 148 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry A. Krishnan, MD, PhD | University of Illinois at Chicago | 312-413-0637 | jakris@uic.edu |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000468 | Alkalies |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
|
| 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
|
| OG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
|
| OG002 |
| 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
|
| OG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
|
| OG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
|
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| OG002 | 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)] 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-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. |
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