Chronic Obstructive Pulmonary Disease (COPD)Phase 4PELICANNCT02098369
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
A Phase 4 study testing Written education material (basic), Additional education material and PELICAN-Proactive in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Illinois Chicago at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Written education material (basic), Additional education material and PELICAN-Proactive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to read and speak English.
- Discharge to home hospice or expected survival less than 6 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Illinois Hospital
Chicago, Illinois, 60612
National Jewish Health
Denver, Colorado, 80206
Apria Healthcare
Lake Forest, California, 92630
AlphaNet
Miami, Florida, 33134
COPD Foundation
Miami, Florida, 33134
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
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).
Read the 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).
- Being tested
- Written education material (basic), Additional education material, PELICAN-Proactive, PELICAN-Reactive
- Keywords
- Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written education material (basic)Behavioural
Education material on COPD distributed to all participants.
Additional education materialBehavioural
Additional education material sent to participants in the proactive and reactive arms.
PELICAN-ProactiveBehavioural
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-ReactiveBehavioural
Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Written education material (basic) Receives: Behavioral: 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)] Receives: Behavioral: Written education material (basic); Behavioral: Additional education material; Behavioral: PELICAN-Proactive |
| 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)] Receives: Behavioral: Written education material (basic); Behavioral: Additional education material; Behavioral: PELICAN-Reactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Supplemental O2 Prescription
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
Measured: 60 days
Secondary outcomes (7)
PROMIS - Physical Function
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
Measured: 60 days
PROMIS - Fatigue
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
Measured: 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.)
Measured: 60 days
PROMIS - Sleep Disturbance
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Jerry Krishnan, University of Illinois Chicago
- Investigators
- Jerry A Krishnan, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098369
- Sponsor's protocol ID
- PCORI-CE 1304-6490
- Acronym
- PELICAN
- Status last verified
- Nov 2017
- First submitted
- 14 Mar 2014
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37683098
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
- ClinicalTrials.gov ID
- NCT02098369
- Acronym / sponsor ID
- PELICAN / PCORI-CE 1304-6490
- Keywords
- Chronic obstructive pulmonary disease (COPD), Supplemental oxygen, Adherence, Telephonic education, Peer coaching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- 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
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Behavioral: Written education material (basic)Written education material (basic) |
| Proactive | Experimental | Behavioral: Written education material (basic), Behavioral: Additional education material, Behavioral: PELICAN-ProactiveWritten 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 | Behavioral: Written education material (basic), Behavioral: Additional education material, Behavioral: PELICAN-ReactiveWritten 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)] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to read and speak English.
- Discharge to home hospice or expected survival less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written education material (basic)Education material on COPD distributed to all participants. | Behavioural | Proactive, Reactive, Usual care |
| Additional education materialAdditional education material sent to participants in the proactive and reactive arms. | Behavioural | Proactive, Reactive |
| PELICAN-ProactiveIn 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. | Behavioural | Proactive |
| PELICAN-ReactiveParticipants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free. | Behavioural | Reactive |
Primary outcome
Adherence to Supplemental O2 Prescription
Time frame: 60 days
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
7 secondary outcomes
PROMIS - Physical Function
Time frame: 60 days
PROMIS - Fatigue
Time frame: 60 days
PROMIS - Emotional Distress - Anxiety
Time frame: 60 days
PROMIS - Sleep Disturbance
Time frame: 60 days
PROMIS - Emotional Distress - Depression
Time frame: 60 days
PROMIS - Satisfaction With Social Roles and Activities
Time frame: 60 days
PROMIS - Ability to Participate in Social Roles and Activities
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37683098Prieto-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.
- Patient-Centered Outcomes Research Institute (PCORI): Funding Award detailsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry A Krishnan, MD, PhD principal investigator
University of Illinois Chicago
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Written education material (basic), Additional education material and PELICAN-Proactive in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Illinois Chicago at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Supplemental O2 Prescription (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.