Trial Outcomes & Findings for Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (NCT NCT02098369)
NCT ID: NCT02098369
Last Updated: 2018-08-06
Results Overview
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
444 participants
Primary outcome timeframe
60 days
Results posted on
2018-08-06
Participant Flow
Participant milestones
| Measure |
Usual Care
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\]
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
142
|
154
|
148
|
|
Overall Study
COMPLETED
|
135
|
145
|
143
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
Usual Care
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
Written education material (basic) Additional education material PELICAN-Proactive \[In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)\]
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
3
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
2
|
1
|
Baseline Characteristics
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
Baseline characteristics by cohort
| Measure |
Usual Care
n=142 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=154 Participants
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.
|
Reactive
n=148 Participants
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.
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: All participants with evaluable data for oxygen use across all equipment.
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
Outcome measures
| Measure |
Usual Care
n=104 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=105 Participants
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.
|
Reactive
n=116 Participants
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.
|
|---|---|---|---|
|
Adherence to Supplemental O2 Prescription
|
77 Participants
|
73 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)
Outcome measures
| Measure |
Usual Care
n=131 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=134 Participants
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.
|
Reactive
n=139 Participants
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.
|
|---|---|---|---|
|
PROMIS - Physical Function
|
-0.5 T-score
Standard Error 0.3
|
-0.1 T-score
Standard Error 0.3
|
-0.2 T-score
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)
Outcome measures
| Measure |
Usual Care
n=130 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=144 Participants
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.
|
Reactive
n=142 Participants
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.
|
|---|---|---|---|
|
PROMIS - Fatigue
|
0.1 T-score
Standard Error 0.7
|
-1.0 T-score
Standard Error 0.6
|
0.3 T-score
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)
Outcome measures
| Measure |
Usual Care
n=136 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=142 Participants
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.
|
Reactive
n=139 Participants
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.
|
|---|---|---|---|
|
PROMIS - Emotional Distress - Anxiety
|
0.3 T-score
Standard Error 0.7
|
-1.2 T-score
Standard Error 0.7
|
-0.1 T-score
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)
Outcome measures
| Measure |
Usual Care
n=135 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=142 Participants
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.
|
Reactive
n=140 Participants
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.
|
|---|---|---|---|
|
PROMIS - Sleep Disturbance
|
-0.4 T-score
Standard Error 0.7
|
-2.1 T-score
Standard Error 0.6
|
-0.8 T-score
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)
Outcome measures
| Measure |
Usual Care
n=135 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=141 Participants
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.
|
Reactive
n=141 Participants
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.
|
|---|---|---|---|
|
PROMIS - Emotional Distress - Depression
|
1.1 T-score
Standard Error 0.6
|
-1.8 T-score
Standard Error 0.7
|
0.5 T-score
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)
Outcome measures
| Measure |
Usual Care
n=127 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=127 Participants
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.
|
Reactive
n=127 Participants
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.
|
|---|---|---|---|
|
PROMIS - Satisfaction With Social Roles and Activities
|
0.5 T-score
Standard Error 0.6
|
0.2 T-score
Standard Error 0.6
|
-1.2 T-score
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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.
Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)
Outcome measures
| Measure |
Usual Care
n=121 Participants
Written education material (basic)
Written education material (basic): Education material on COPD distributed to all participants.
|
Proactive
n=131 Participants
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.
|
Reactive
n=130 Participants
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.
|
|---|---|---|---|
|
PROMIS - Ability to Participate in Social Roles and Activities
|
1.0 T-score
Standard Error 0.6
|
1.4 T-score
Standard Error 0.6
|
0.9 T-score
Standard Error 0.6
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reactive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jerry A. Krishnan, MD, PhD
University of Illinois at Chicago
Phone: 312-413-0637
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place