Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT05106257
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2021-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda_mathew@rush.edu', 'phone': '(312 563-1273', 'title': 'Amanda R. Mathew, PhD', 'organization': 'Rush University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Self-management Education (Short)', 'description': 'Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Self-management Education (Long)', 'description': 'Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ground-based Walking Training (on)', 'description': 'Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Ground-based Walking Training (Off)', 'description': 'Not randomized to receive ground-based walking training.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Inhaler Training (on)', 'description': 'Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Inhaler Training (Off)', 'description': 'Not randomized to receive inhaler training.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 10, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Caregiver Support (on)', 'description': "Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.", 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 7, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Caregiver Support (Off)', 'description': 'Not randomized to receive caregiver support.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Symptoms requiring immediate medical attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COPD exacerbation/ hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-management Education (Short)', 'description': 'Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.'}, {'id': 'OG001', 'title': 'Self-management Education (Long)', 'description': 'Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'OG002', 'title': 'Ground-based Walking Training (on)', 'description': 'Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.'}, {'id': 'OG003', 'title': 'Ground-based Walking Training (Off)', 'description': 'Not randomized to receive ground-based walking training.'}, {'id': 'OG004', 'title': 'Inhaler Training (on)', 'description': 'Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'OG005', 'title': 'Inhaler Training (Off)', 'description': 'Not randomized to receive inhaler training'}, {'id': 'OG006', 'title': 'Caregiver Support (on)', 'description': "Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'OG007', 'title': 'Caregiver Support (Off)', 'description': 'Not randomized to receive caregiver support'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '1.2', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG004'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'OG005'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG006'}, {'value': '0.5', 'spread': '1.4', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Please note that the Arms/ Groups in the Outcome Measures are a recombination of the Participant Flow Arms/ Groups to report results by factor.'}, {'type': 'SECONDARY', 'title': 'COPD Symptom Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-management Education (Short)', 'description': 'Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.'}, {'id': 'OG001', 'title': 'Self-management Education (Long)', 'description': 'Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'OG002', 'title': 'Ground-based Walking Training (on)', 'description': 'Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.'}, {'id': 'OG003', 'title': 'Ground-based Walking Training (Off)', 'description': 'Not randomized to receive ground-based walking training.'}, {'id': 'OG004', 'title': 'Inhaler Training (on)', 'description': 'Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'OG005', 'title': 'Inhaler Training (Off)', 'description': 'Not randomized to receive inhaler training'}, {'id': 'OG006', 'title': 'Caregiver Support (on)', 'description': "Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'OG007', 'title': 'Caregiver Support (Off)', 'description': 'Not randomized to receive caregiver support'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '6', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '5', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '4.9', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '5.8', 'groupId': 'OG003'}, {'value': '-0.4', 'spread': '4.3', 'groupId': 'OG004'}, {'value': '-4.3', 'spread': '5.9', 'groupId': 'OG005'}, {'value': '-0.6', 'spread': '4.5', 'groupId': 'OG006'}, {'value': '-4.4', 'spread': '5.9', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-management Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-management Education (Short)', 'description': 'Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.'}, {'id': 'OG001', 'title': 'Self-management Education (Long)', 'description': 'Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'OG002', 'title': 'Ground-based Walking Training (on)', 'description': 'Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.'}, {'id': 'OG003', 'title': 'Ground-based Walking Training (Off)', 'description': 'Not randomized to receive ground-based walking training.'}, {'id': 'OG004', 'title': 'Inhaler Training (on)', 'description': 'Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'OG005', 'title': 'Inhaler Training (Off)', 'description': 'Not randomized to receive inhaler training'}, {'id': 'OG006', 'title': 'Caregiver Support (on)', 'description': "Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'OG007', 'title': 'Caregiver Support (Off)', 'description': 'Not randomized to receive caregiver support'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '18', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '17.9', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '18', 'groupId': 'OG003'}, {'value': '3.1', 'spread': '20.9', 'groupId': 'OG004'}, {'value': '11.6', 'spread': '15', 'groupId': 'OG005'}, {'value': '8.3', 'spread': '13.9', 'groupId': 'OG006'}, {'value': '8', 'spread': '21.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-management Education (Short)', 'description': 'Self-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.'}, {'id': 'OG001', 'title': 'Self-management Education (Long)', 'description': 'Self-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'OG002', 'title': 'Ground-based Walking Training (on)', 'description': 'Ground-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.'}, {'id': 'OG003', 'title': 'Ground-based Walking Training (Off)', 'description': 'Not randomized to receive ground-based walking training.'}, {'id': 'OG004', 'title': 'Inhaler Training (on)', 'description': 'Inhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'OG005', 'title': 'Inhaler Training (Off)', 'description': 'Not randomized to receive inhaler training'}, {'id': 'OG006', 'title': 'Caregiver Support (on)', 'description': "Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'OG007', 'title': 'Caregiver Support (Off)', 'description': 'Not randomized to receive caregiver support'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Incidence at 90-day follow-up', 'description': 'Self-reported hospitalization history.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Condition #1', 'description': "Education = short Walking training = on Inhaler training = on Caregiver support = on\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The short condition consists of two calls (30-45 minutes each).\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks.\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'FG001', 'title': 'Condition #2', 'description': 'Education = short Walking training = on Inhaler training = on Caregiver support = off\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'FG002', 'title': 'Condition #3', 'description': "Education = short Walking training = on Inhaler training = off Caregiver support = on\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The short condition consists of two calls (30-45 minutes each).\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'FG003', 'title': 'Condition #4', 'description': 'Education = short Walking training = on Inhaler training = off Caregiver support = off\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.'}, {'id': 'FG004', 'title': 'Condition #5', 'description': "Education = short Walking training = off Inhaler training = on Caregiver support = on\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The short condition consists of two calls (30-45 minutes each).\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member."}, {'id': 'FG005', 'title': 'Condition #6', 'description': 'Education = short Walking training = off Inhaler training = on Caregiver support = off\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.'}, {'id': 'FG006', 'title': 'Condition #7', 'description': "Education = short Walking training = off Inhaler training = off Caregiver support = on\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver who is involved in their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit, a comprehensive informational resource to support the care of the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. The structured content of these sessions will include providing an overview of toolkit content, identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any questions."}, {'id': 'FG007', 'title': 'Condition #8', 'description': 'Education = short Walking training = off Inhaler training = off Caregiver support = off\n\nSelf-management education (short): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.'}, {'id': 'FG008', 'title': 'Condition #9', 'description': "Education = long Walking training = on Inhaler training = on Caregiver support = on\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks.\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The long condition consists of five, weekly calls (30-45 minutes each)."}, {'id': 'FG009', 'title': 'Condition #10', 'description': 'Education = long Walking training = on Inhaler training = on Caregiver support = off\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'FG010', 'title': 'Condition #11', 'description': "Education = long Walking training = on Inhaler training = off Caregiver support = on\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The long condition consists of five, weekly calls (30-45 minutes each)."}, {'id': 'FG011', 'title': 'Condition #12', 'description': 'Education = long Walking training = on Inhaler training = off Caregiver support = off\n\nGround-based walking training: Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'FG012', 'title': 'Condition #13', 'description': "Education = long Walking training = off Inhaler training = on Caregiver support = on\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. The long condition consists of five, weekly calls (30-45 minutes each)."}, {'id': 'FG013', 'title': 'Condition #14', 'description': 'Education = long Walking training = off Inhaler training = on Caregiver support = off\n\nInhaler training: Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}, {'id': 'FG014', 'title': 'Condition #15', 'description': "Education = long Walking training = off Inhaler training = off Caregiver support = on\n\nCaregiver support: Participants randomized to this condition will identify an informal caregiver who is involved in their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit, a comprehensive informational resource to support the care of the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. The structured content of these sessions will include providing an overview of toolkit content, identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any questions.\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics."}, {'id': 'FG015', 'title': 'Condition #16', 'description': 'Education = long Walking training = off Inhaler training = off Caregiver support = off\n\nSelf-management education (long): The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '46', 'groupId': 'BG016'}]}], 'groups': [{'id': 'BG000', 'title': 'Condition #1', 'description': 'Education = short Walking training = on Inhaler training = on Caregiver support = on'}, {'id': 'BG001', 'title': 'Condition #2', 'description': 'Education = short Walking training = on Inhaler training = on Caregiver support = off'}, {'id': 'BG002', 'title': 'Condition #3', 'description': 'Education = short Walking training = on Inhaler training = off Caregiver support = on'}, {'id': 'BG003', 'title': 'Condition #4', 'description': 'Education = short Walking training = on Inhaler training = off Caregiver support = off'}, {'id': 'BG004', 'title': 'Condition #5', 'description': 'Education = short Walking training = off Inhaler training = on Caregiver support = on'}, {'id': 'BG005', 'title': 'Condition #6', 'description': 'Education = short Walking training = off Inhaler training = on Caregiver support = off'}, {'id': 'BG006', 'title': 'Condition #7', 'description': 'Education = short Walking training = off Inhaler training = off Caregiver support = on'}, {'id': 'BG007', 'title': 'Condition #8', 'description': 'Education = short Walking training = off Inhaler training = off Caregiver support = off'}, {'id': 'BG008', 'title': 'Condition #9', 'description': 'Education = long Walking training = on Inhaler training = on Caregiver support = on'}, {'id': 'BG009', 'title': 'Condition #10', 'description': 'Education = long Walking training = on Inhaler training = on Caregiver support = off'}, {'id': 'BG010', 'title': 'Condition #11', 'description': 'Education = long Walking training = on Inhaler training = off Caregiver support = on'}, {'id': 'BG011', 'title': 'Condition #12', 'description': 'Education = long Walking training = on Inhaler training = off Caregiver support = off'}, {'id': 'BG012', 'title': 'Condition #13', 'description': 'Education = long Walking training = off Inhaler training = on Caregiver support = on'}, {'id': 'BG013', 'title': 'Condition #14', 'description': 'Education = long Walking training = off Inhaler training = on Caregiver support = off'}, {'id': 'BG014', 'title': 'Condition #15', 'description': 'Education = long Walking training = off Inhaler training = off Caregiver support = on'}, {'id': 'BG015', 'title': 'Condition #16', 'description': 'Education = long Walking training = off Inhaler training = off Caregiver support = off'}, {'id': 'BG016', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '13', 'groupId': 'BG000'}, {'value': '58', 'spread': '11', 'groupId': 'BG001'}, {'value': '63', 'spread': '2', 'groupId': 'BG002'}, {'value': '66', 'spread': '7', 'groupId': 'BG003'}, {'value': '67', 'spread': '11', 'groupId': 'BG004'}, {'value': '67', 'spread': '1', 'groupId': 'BG005'}, {'value': '65', 'spread': '8', 'groupId': 'BG006'}, {'value': '65', 'spread': '5', 'groupId': 'BG007'}, {'value': '61', 'spread': '27', 'groupId': 'BG008'}, {'value': '63', 'spread': '14', 'groupId': 'BG009'}, {'value': '70', 'spread': '9', 'groupId': 'BG010'}, {'value': '64', 'spread': '8', 'groupId': 'BG011'}, {'value': '74', 'spread': '4', 'groupId': 'BG012'}, {'value': '71', 'spread': '9', 'groupId': 'BG013'}, {'value': '74', 'spread': '1', 'groupId': 'BG014'}, {'value': '74', 'spread': '7', 'groupId': 'BG015'}, {'value': '67', 'spread': '10', 'groupId': 'BG016'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '28', 'groupId': 'BG016'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '18', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '45', 'groupId': 'BG016'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '13', 'groupId': 'BG016'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '30', 'groupId': 'BG016'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '46', 'groupId': 'BG016'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-22', 'size': 601469, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-25T16:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2021-10-12', 'resultsFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related Quality of Life', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life.'}], 'secondaryOutcomes': [{'measure': 'COPD Symptom Burden', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact.'}, {'measure': 'Self-management Behaviors', 'timeFrame': 'Change from baseline at 90-day follow-up', 'description': 'Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management.'}, {'measure': 'Hospitalization', 'timeFrame': 'Incidence at 90-day follow-up', 'description': 'Self-reported hospitalization history.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Self-management', 'Lifestyle change', 'Patient education', 'Quality of life', 'Physical activity', 'Inhaler use', 'Caregiver support'], 'conditions': ['Copd']}, 'descriptionModule': {'briefSummary': 'Although self-management treatment improves quality of life among individuals with COPD, there is limited understanding of which elements of treatment are most effective. The proposed research will test the feasibility of using an engineering-inspired study design to identify effective COPD self-management treatment components. The long-term goal of this line of research is to optimize the effectiveness of COPD self-management treatment, and improve quality of life for individuals with COPD.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health condition, and is the third major cause of morbidity and mortality in the United States. Self-management treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and resource-intensive. To date, no study has been conducted to isolate the role of individual self-management treatment components in contributing to improved COPD outcomes. The proposed research will establish the feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to be evaluated include duration of self-management education, ground-based walking training, inhaler training, and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization. Specific aims are:\n\nAim 1: Design a factorial experiment and develop operational procedures. The investigators will design a factorial experiment with the same number of experimental conditions and length of follow-up as the planned optimization trial. In collaboration with the ALA COPD Helpline, the investigators will develop operational procedures (i.e., recruitment, screening, randomization, and database management) for successful implementation.\n\nAim 2: Establish feasibility and acceptability by pilot testing the study design. The investigators will deliver treatment to three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, mediator, and outcome variables. The investigators will conduct qualitative interviews at end-of-treatment with 15-20 participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nEligible participants will be males and females who are:\n\n1. 40 years or older,\n2. report a physician diagnosis of COPD,\n3. use an inhaler for COPD at least once a week,\n4. able to walk at least one block without assistance,\n5. able to identify a caregiver, and\n6. have access to a connected device (i.e., smart phone, tablet, and/ or computer).\n\nExclusion criteria:\n\n1. cognitive dysfunction impairing ability to provide informed consent and follow study procedures,\n2. terminal illness (i.e. less than 6 months life expectancy) that is non-COPD related,\n3. living at a chronic care facility (i.e. nursing home, assisted living), or\n4. inability to speak and read English.'}, 'identificationModule': {'nctId': 'NCT05106257', 'briefTitle': 'Optimizing Self-management COPD Treatment Through the American Lung Association Helpline', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Optimizing Self-management COPD Treatment Through the American Lung Association Helpline', 'orgStudyIdInfo': {'id': '20050506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Condition #1', 'description': 'Education = short Walking training = on Inhaler training = on Caregiver support = on', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Ground-based walking training', 'Behavioral: Inhaler training', 'Behavioral: Caregiver support']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #2', 'description': 'Education = short Walking training = on Inhaler training = on Caregiver support = off', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Ground-based walking training', 'Behavioral: Inhaler training']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #3', 'description': 'Education = short Walking training = on Inhaler training = off Caregiver support = on', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Ground-based walking training', 'Behavioral: Caregiver support']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #4', 'description': 'Education = short Walking training = on Inhaler training = off Caregiver support = off', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Ground-based walking training']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #5', 'description': 'Education = short Walking training = off Inhaler training = on Caregiver support = on', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Inhaler training', 'Behavioral: Caregiver support']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #6', 'description': 'Education = short Walking training = off Inhaler training = on Caregiver support = off', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Inhaler training']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #7', 'description': 'Education = short Walking training = off Inhaler training = off Caregiver support = on', 'interventionNames': ['Behavioral: Self-management education (short)', 'Behavioral: Caregiver support']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #8', 'description': 'Education = short Walking training = off Inhaler training = off Caregiver support = off', 'interventionNames': ['Behavioral: Self-management education (short)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #9', 'description': 'Education = long Walking training = on Inhaler training = on Caregiver support = on', 'interventionNames': ['Behavioral: Ground-based walking training', 'Behavioral: Inhaler training', 'Behavioral: Caregiver support', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #10', 'description': 'Education = long Walking training = on Inhaler training = on Caregiver support = off', 'interventionNames': ['Behavioral: Ground-based walking training', 'Behavioral: Inhaler training', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #11', 'description': 'Education = long Walking training = on Inhaler training = off Caregiver support = on', 'interventionNames': ['Behavioral: Ground-based walking training', 'Behavioral: Caregiver support', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #12', 'description': 'Education = long Walking training = on Inhaler training = off Caregiver support = off', 'interventionNames': ['Behavioral: Ground-based walking training', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #13', 'description': 'Education = long Walking training = off Inhaler training = on Caregiver support = on', 'interventionNames': ['Behavioral: Inhaler training', 'Behavioral: Caregiver support', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #14', 'description': 'Education = long Walking training = off Inhaler training = on Caregiver support = off', 'interventionNames': ['Behavioral: Inhaler training', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #15', 'description': 'Education = long Walking training = off Inhaler training = off Caregiver support = on', 'interventionNames': ['Behavioral: Caregiver support', 'Behavioral: Self-management education (long)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition #16', 'description': 'Education = long Walking training = off Inhaler training = off Caregiver support = off', 'interventionNames': ['Behavioral: Self-management education (long)']}], 'interventions': [{'name': 'Self-management education (short)', 'type': 'BEHAVIORAL', 'description': 'The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.', 'armGroupLabels': ['Condition #1', 'Condition #2', 'Condition #3', 'Condition #4', 'Condition #5', 'Condition #6', 'Condition #7', 'Condition #8']}, {'name': 'Ground-based walking training', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.', 'armGroupLabels': ['Condition #1', 'Condition #10', 'Condition #11', 'Condition #12', 'Condition #2', 'Condition #3', 'Condition #4', 'Condition #9']}, {'name': 'Inhaler training', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.', 'armGroupLabels': ['Condition #1', 'Condition #10', 'Condition #13', 'Condition #14', 'Condition #2', 'Condition #5', 'Condition #6', 'Condition #9']}, {'name': 'Caregiver support', 'type': 'BEHAVIORAL', 'description': "Participants randomized to this condition will identify an informal caregiver who is involved in their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit, a comprehensive informational resource to support the care of the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. The structured content of these sessions will include providing an overview of toolkit content, identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any questions.", 'armGroupLabels': ['Condition #1', 'Condition #11', 'Condition #13', 'Condition #15', 'Condition #3', 'Condition #5', 'Condition #7', 'Condition #9']}, {'name': 'Self-management education (long)', 'type': 'BEHAVIORAL', 'description': 'The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.', 'armGroupLabels': ['Condition #10', 'Condition #11', 'Condition #12', 'Condition #13', 'Condition #14', 'Condition #15', 'Condition #16', 'Condition #9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Amanda R Mathew, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}