Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching
Brief 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).
Detailed 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).
Interventions
BEHAVIORALWritten education material (basic)
Education material on COPD distributed to all participants.
BEHAVIORALAdditional education material
Additional education material sent to participants in the proactive and reactive arms.
BEHAVIORALPELICAN-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.
BEHAVIORALPELICAN-Reactive
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
Sponsors
AlphaNet
Apria Healthcare
COPD Foundation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
National Jewish Health
Patient-Centered Outcomes Research Institute
American Association for Respiratory Care
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Supplemental O2 Prescription | 60 days | Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Physical Function | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.) |
| PROMIS - Fatigue | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.) |
| PROMIS - Sleep Disturbance | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.) |
| PROMIS - Emotional Distress - Anxiety | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.) |
| PROMIS - Satisfaction With Social Roles and Activities | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.) |
| PROMIS - Ability to Participate in Social Roles and Activities | 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.) |
| PROMIS - Emotional Distress - Depression | 60 days | Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants. | 142 |
| 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. | 154 |
| 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. | 148 |
| Total | 444 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 1 | 3 |
| Overall Study | Other | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Proactive | Reactive | Total |
|---|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 9 | 68.0 years STANDARD_DEVIATION 8.8 | 65.9 years STANDARD_DEVIATION 8.4 | 66.8 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 0 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 136 Participants | 146 Participants | 146 Participants | 428 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 31 Participants | 26 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 111 Participants | 116 Participants | 117 Participants | 344 Participants |
| Sex: Female, Male Female | 88 Participants | 111 Participants | 103 Participants | 302 Participants |
| Sex: Female, Male Male | 54 Participants | 43 Participants | 45 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 142 | 0 / 154 | 0 / 148 |
| serious Total, serious adverse events | 0 / 142 | 0 / 154 | 0 / 148 |
Outcome results
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
Time frame: 60 days
Population: All participants with evaluable data for oxygen use across all equipment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Adherence to Supplemental O2 Prescription | 77 Participants |
| Proactive | Adherence to Supplemental O2 Prescription | 73 Participants |
| Reactive | Adherence to Supplemental O2 Prescription | 97 Participants |
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.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Ability to Participate in Social Roles and Activities | 1.0 T-score | Standard Error 0.6 |
| Proactive | PROMIS - Ability to Participate in Social Roles and Activities | 1.4 T-score | Standard Error 0.6 |
| Reactive | PROMIS - Ability to Participate in Social Roles and Activities | 0.9 T-score | Standard Error 0.6 |
Secondary
PROMIS - Emotional Distress - Anxiety
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Emotional Distress - Anxiety | 0.3 T-score | Standard Error 0.7 |
| Proactive | PROMIS - Emotional Distress - Anxiety | -1.2 T-score | Standard Error 0.7 |
| Reactive | PROMIS - Emotional Distress - Anxiety | -0.1 T-score | Standard Error 0.6 |
Secondary
PROMIS - Emotional Distress - Depression
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Emotional Distress - Depression | 1.1 T-score | Standard Error 0.6 |
| Proactive | PROMIS - Emotional Distress - Depression | -1.8 T-score | Standard Error 0.7 |
| Reactive | PROMIS - Emotional Distress - Depression | 0.5 T-score | Standard Error 0.7 |
Secondary
PROMIS - Fatigue
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Fatigue | 0.1 T-score | Standard Error 0.7 |
| Proactive | PROMIS - Fatigue | -1.0 T-score | Standard Error 0.6 |
| Reactive | PROMIS - Fatigue | 0.3 T-score | Standard Error 0.6 |
Secondary
PROMIS - Physical Function
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Physical Function | -0.5 T-score | Standard Error 0.3 |
| Proactive | PROMIS - Physical Function | -0.1 T-score | Standard Error 0.3 |
| Reactive | PROMIS - Physical Function | -0.2 T-score | Standard Error 0.3 |
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.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Satisfaction With Social Roles and Activities | 0.5 T-score | Standard Error 0.6 |
| Proactive | PROMIS - Satisfaction With Social Roles and Activities | 0.2 T-score | Standard Error 0.6 |
| Reactive | PROMIS - Satisfaction With Social Roles and Activities | -1.2 T-score | Standard Error 0.6 |
Secondary
PROMIS - Sleep Disturbance
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
Time frame: 60 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | PROMIS - Sleep Disturbance | -0.4 T-score | Standard Error 0.7 |
| Proactive | PROMIS - Sleep Disturbance | -2.1 T-score | Standard Error 0.6 |
| Reactive | PROMIS - Sleep Disturbance | -0.8 T-score | Standard Error 0.7 |