Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-17 @ 12:43 PM
Study NCT ID:
NCT02098369
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2014-03-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000468', 'term': 'Alkalies'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jakris@uic.edu', 'phone': '312-413-0637', 'title': 'Jerry A. Krishnan, MD, PhD', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.', 'otherNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.', 'otherNumAtRisk': 154, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Supplemental O2 Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with evaluable data for oxygen use across all equipment.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Emotional Distress - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Emotional Distress - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Satisfaction With Social Roles and Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS - Ability to Participate in Social Roles and Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'OG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'OG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'FG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'FG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '444', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Written education material (basic)\n\nWritten education material (basic): Education material on COPD distributed to all participants.'}, {'id': 'BG001', 'title': 'Proactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-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.'}, {'id': 'BG002', 'title': 'Reactive', 'description': '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)\\]\n\nWritten education material (basic): Education material on COPD distributed to all participants.\n\nAdditional education material: Additional education material sent to participants in the proactive and reactive arms.\n\nPELICAN-Reactive: Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '65.9', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '66.8', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2014-03-14', 'resultsFirstSubmitDate': '2016-12-30', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-06', 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Supplemental O2 Prescription', 'timeFrame': '60 days', 'description': 'Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day'}], 'secondaryOutcomes': [{'measure': 'PROMIS - Physical Function', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)'}, {'measure': 'PROMIS - Fatigue', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)'}, {'measure': 'PROMIS - Emotional Distress - Anxiety', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)'}, {'measure': 'PROMIS - Sleep Disturbance', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)'}, {'measure': 'PROMIS - Emotional Distress - Depression', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)'}, {'measure': 'PROMIS - Satisfaction With Social Roles and Activities', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)'}, {'measure': 'PROMIS - Ability to Participate in Social Roles and Activities', 'timeFrame': '60 days', 'description': 'Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease (COPD)', 'Supplemental oxygen', 'Adherence', 'Telephonic education', 'Peer coaching'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '37683098', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.pcori.org/research-results/2013/comparative-effectiveness-peer-led-supplemental-o2-infoline-patients-and', 'label': 'Patient-Centered Outcomes Research Institute (PCORI): Funding Award details'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Physician diagnosis of COPD\n3. Physician prescription for home O2 for 24hrs/day, 7 days/week\n4. Willing to use home O2.\n5. Working telephone number.\n\nExclusion Criteria:\n\n1. Unable to read and speak English.\n2. Discharge to home hospice or expected survival less than 6 months.'}, 'identificationModule': {'nctId': 'NCT02098369', 'acronym': 'PELICAN', 'briefTitle': 'Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)', 'orgStudyIdInfo': {'id': 'PCORI-CE 1304-6490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual care', 'description': 'Written education material (basic)', 'interventionNames': ['Behavioral: Written education material (basic)']}, {'type': 'EXPERIMENTAL', 'label': 'Proactive', 'description': '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)\\]', 'interventionNames': ['Behavioral: Written education material (basic)', 'Behavioral: Additional education material', 'Behavioral: PELICAN-Proactive']}, {'type': 'EXPERIMENTAL', 'label': 'Reactive', 'description': '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)\\]', 'interventionNames': ['Behavioral: Written education material (basic)', 'Behavioral: Additional education material', 'Behavioral: PELICAN-Reactive']}], 'interventions': [{'name': 'Written education material (basic)', 'type': 'BEHAVIORAL', 'description': 'Education material on COPD distributed to all participants.', 'armGroupLabels': ['Proactive', 'Reactive', 'Usual care']}, {'name': 'Additional education material', 'type': 'BEHAVIORAL', 'description': 'Additional education material sent to participants in the proactive and reactive arms.', 'armGroupLabels': ['Proactive', 'Reactive']}, {'name': 'PELICAN-Proactive', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Proactive']}, {'name': 'PELICAN-Reactive', 'type': 'BEHAVIORAL', 'description': 'Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.', 'armGroupLabels': ['Reactive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'country': 'United States', 'facility': 'Apria Healthcare', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'AlphaNet', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'COPD Foundation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jerry A Krishnan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'AlphaNet', 'class': 'UNKNOWN'}, {'name': 'Apria Healthcare', 'class': 'UNKNOWN'}, {'name': 'COPD Foundation', 'class': 'OTHER'}, {'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, {'name': 'National Jewish Health', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'American Association for Respiratory Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Public Health; Associate Vice Chancellor for Population Health Sciences', 'investigatorFullName': 'Jerry Krishnan', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}