Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 7:02 AM
Study NCT ID:
NCT02240069
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wood Smoke Interventions in Native American Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'curtis.noonan@umontana.edu', 'phone': '406-243-4957', 'title': 'Curtis Noonan', 'organization': 'University of Montana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Two consecutive winter periods, approximately 16 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-intervention FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.02', 'groupDescription': 'Pre- to post-intervention change in FEV1 for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}, {'pValue': '0.90', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.13', 'groupDescription': 'Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Valid post-intervention spirometry measures captured for 127 of 143 participants'}, {'type': 'PRIMARY', 'title': 'Post-intervention FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.07', 'groupDescription': 'Pre- to post-intervention change in FVC for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}, {'pValue': '0.89', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.16', 'groupDescription': 'Pre- to post-intervention change in FVC for Filter group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced vital capacity (FVC), liters', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Valid post-intervention spirometry measures captured for 127 of 143 participants'}, {'type': 'PRIMARY', 'title': 'Post-intervention FEV1/FVC Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.00', 'groupDescription': 'Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}, {'pValue': '0.71', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.02', 'groupDescription': 'Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Valid post-intervention spirometry measures captured for 127 of 143 participants'}, {'type': 'PRIMARY', 'title': 'Post-intervention Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'spread': '16', 'groupId': 'OG000'}, {'value': '139', 'spread': '17', 'groupId': 'OG001'}, {'value': '136', 'spread': '22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.46', 'ciLowerLimit': '-11.45', 'ciUpperLimit': '4.54', 'groupDescription': 'Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}, {'pValue': '0.95', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-7.73', 'ciUpperLimit': '8.24', 'groupDescription': 'Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Valid post-intervention blood pressure measures captured for 128 of 143 participants'}, {'type': 'PRIMARY', 'title': 'Post-intervention Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '11', 'groupId': 'OG000'}, {'value': '78', 'spread': '11', 'groupId': 'OG001'}, {'value': '76', 'spread': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '3.42', 'groupDescription': 'Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}, {'pValue': '0.79', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-4.97', 'ciUpperLimit': '3.81', 'groupDescription': 'Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Valid post-intervention blood pressure measures captured for 128 of 143 participants'}, {'type': 'SECONDARY', 'title': 'Post-intervention Indoor Fine Particulate Matter (PM2.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}, {'units': 'Household', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'OG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'OG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '51.5', 'groupId': 'OG001'}, {'value': '41.6', 'spread': '39.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-33.6', 'ciUpperLimit': '42.0', 'groupDescription': 'Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.5', 'ciLowerLimit': '-66.1', 'ciUpperLimit': '-27.8', 'groupDescription': 'Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.'}], 'paramType': 'MEAN', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.', 'description': 'Post-intervention average Indoor fine particulate matter (PM2.5) concentration', 'unitOfMeasure': 'microgram/cubic meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Household', 'denomUnitsSelected': 'Household', 'populationDescription': 'Valid post-intervention PM2.5 measures captured for 123 of 143 households'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'FG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'FG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '47', 'numSubjects': '49'}, {'groupId': 'FG001', 'numUnits': '46', 'numSubjects': '47'}, {'groupId': 'FG002', 'numUnits': '45', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '43', 'numSubjects': '44'}, {'groupId': 'FG001', 'numUnits': '41', 'numSubjects': '42'}, {'groupId': 'FG002', 'numUnits': '43', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '5'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Household', 'preAssignmentDetails': 'For this pre/post study recruited and consented participants completed baseline measures during a pre-intervention period (n=149). Randomization to arms occurred after the first (baseline) period and before the second (post-intervention) period. Six participants dropped out of the study before the randomization process. Thus, only 143 participants were randomized to a treatment arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Education (Tx1)', 'description': 'Education on best burn practices\n\nEducation (Tx1): Education on best burn practices'}, {'id': 'BG001', 'title': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.\n\nAir Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove'}, {'id': 'BG002', 'title': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.\n\nPlacebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '68.9', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '69.6', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Specific age for one participant not disclosed; all participants 55 years or older'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Forced expiratory volume in 1 second (FEV1)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '2.0', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '2.0', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Valid spirometry measures captured for 133 of 143 participants'}, {'title': 'Forced vital capacity (FVC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Valid spirometry measures captured for 133 of 143 participants'}, {'title': 'FEV1/FVC', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.08', 'groupId': 'BG000'}, {'value': '0.80', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '0.79', 'spread': '0.08', 'groupId': 'BG002'}, {'value': '0.79', 'spread': '0.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Valid spirometry measures captured for 133 of 143 participants'}, {'title': 'Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '132', 'spread': '18', 'groupId': 'BG000'}, {'value': '143', 'spread': '19', 'groupId': 'BG001'}, {'value': '137', 'spread': '20', 'groupId': 'BG002'}, {'value': '137', 'spread': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Valid blood pressure measures captured for 130 of 143 participants'}, {'title': 'Diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '11', 'groupId': 'BG000'}, {'value': '79', 'spread': '10', 'groupId': 'BG001'}, {'value': '77', 'spread': '14', 'groupId': 'BG002'}, {'value': '77', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Valid blood pressure measures captured for 130 of 143 participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-15', 'size': 1008556, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-14T15:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2014-09-10', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-02', 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-intervention FEV1', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters'}, {'measure': 'Post-intervention FVC', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced vital capacity (FVC), liters'}, {'measure': 'Post-intervention FEV1/FVC Ratio', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)'}, {'measure': 'Post-intervention Systolic Blood Pressure', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)'}, {'measure': 'Post-intervention Diastolic Blood Pressure', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.', 'description': 'Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)'}], 'secondaryOutcomes': [{'measure': 'Post-intervention Indoor Fine Particulate Matter (PM2.5)', 'timeFrame': 'Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.', 'description': 'Post-intervention average Indoor fine particulate matter (PM2.5) concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory; Disorder, Functional, Impaired', 'Respiratory Infection Other']}, 'descriptionModule': {'briefSummary': 'A critical need exists for efficient community-based interventions aimed at reduction of environmental exposures relevant to health. Biomass smoke exposures due to residential wood heating are common among rural Native American communities, and such exposures have been associated with respiratory disease in susceptible populations. In many of these communities wood stoves are the most economic and traditionally preferred method of residential heating, but resource scarcity can result in burning of improper wood fuels and corresponding high levels of indoor particulate matter. Community-based participatory research techniques will be used to adapt intervention approaches to meet the cultural context of each participating community. At the community level, investigators will facilitate local development of a tribal agency-led wood bank program ensuring that elderly and/or persons with need have access to dry wood for heating. At the household level, investigators will use a three arm randomized placebo-controlled intervention trial to implement and assess education/outreach on best burn practices (Tx1). The content and delivery strategies of the education intervention will be adapted to each community according to stakeholder input. This educational intervention will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to evaluate the penetration and efficacy of the community-level wood bank program. Outcomes will be evaluated with respect to changes in pulmonary function measures and respiratory symptoms and conditions among household elders. The investigators hypothesize that locally-designed education-based interventions at the community and household levels will result in efficacious and sustainable strategies for reducing personal exposures to indoor particulate matter, and lead to respiratory health improvements in elderly Native populations. This study will advance knowledge of cost-effective environmental interventions within two unique Native American communities, and inform sustainable multi-level strategies in similar communities throughout the US to improve respiratory health among at-risk populations.', 'detailedDescription': "Rural Native American (NA) communities experience disproportionate disease burden compared to other US populations, with poor indoor air quality resulting from in-home biomass smoke exposures (residential wood stoves) a likely contributor to these health burden discrepancies. Epidemiological studies support the etiological association between indoor biomass smoke exposure and several domains of global disease burden, particularly with respect to pediatric respiratory tract infections and adult chronic obstructive pulmonary disease (COPD) and chronic bronchitis. Elderly populations are particularly susceptible to chronic respiratory conditions, and declining pulmonary function is associated with increased morbidity and mortality. Randomized trials in developing countries have demonstrated the impact that improved cookstove technologies have in reducing biomass smoke exposures and children's risk of acute respiratory infection. However limited knowledge is available regarding the potential improvements in NA elderly populations following wood stove interventions.\n\nToday, a critical need exists for efficient community-based interventions aimed at promoting healthy indoor environments in at-risk communities. Financial and logistical barriers that currently exist in rural and economically disadvantaged NA communities prohibit the implementation and sustainability of many environmental health interventions. Regarding wood stoves, qualitative input from experts and Native communities underscores the need for innovative low-cost, sustainable interventions targeting the reduction of in-home biomass smoke exposures. In this proposal, investigators will test community-level and education-based household-level strategies aimed at promoting and implementing best-burn practices to improve air quality and respiratory health in at-risk elderly populations.\n\nThis proposal represents a multidisciplinary collaboration between university and tribal stakeholders from two Native American Reservations to develop, adapt, implement, and evaluate a two-level intervention to reduce exposure to indoor biomass smoke and improve respiratory health among elderly tribal members. Community-based participatory research techniques will be used to adapt intervention approaches to meet the cultural context of each participating community. At the community level, investigators will facilitate local development of tribal agency-led wood yard and distribution programs ensuring that elderly and/or persons with need have access to dry wood for heating. With community advisory guidance, investigators will use a three arm randomized placebo-controlled intervention trial to implement and assess education on best burn practices (Tx1) at the household level. This educational intervention will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to evaluate the penetration and efficacy of the community-level fuel program. Outcomes will be evaluated with respect to changes in markers of respiratory health among elders and changes in indoor air quality (PM2.5). The investigators hypothesize that locally-designed education-based interventions, in the context of a community-based strategy focused on wood fuels, will result in efficacious and sustainable strategies for reducing personal exposures to indoor biomass smoke PM2.5 and lead to respiratory health improvements in elderly NA populations.\n\nSpecific Aims are as follows:\n\nAim 1. Facilitate the tribally-centered development, adaption, implementation, and evaluation of community-level wood yard and distribution programs for participating tribal households.\n\nAim 2. Facilitate the development, adaptation, implementation, and evaluation of household-level education strategies targeting best-burn practices (Tx1) for each participating tribal community.\n\nAim 3. Compare effectiveness, both within and between communities, of household-level interventions among elderly adults participating in a three-arm randomized placebo-controlled trial.\n\nAim 3a. Compare group changes in pulmonary function and respiratory symptoms and infections.\n\nAim 3b. Compare group changes in indoor and personal PM2.5 exposures.\n\nAim 4. Evaluate penetration, acceptance, and sustainability of community- and household-level strategies using both qualitative and quantitative data generated in collaboration with tribal community advisory boards and research participants.\n\nImpact. The long-term goal of this project will be to reduce mortality and morbidity in NA communities from exposures related to residential home heating. This study will advance knowledge of effective interventions within two unique NA Reservations and describe improvements in sub-clinical indicators of pulmonary health in susceptible elderly populations. Reducing in-home wood smoke exposures through community level facilitation of access to proper fuels and introduction of sustainable, culturally appropriate best-burn practices will inform strategies for translation to other NA communities or similar rural and underserved populations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tribal member from one of the two study regions\n* Age 55 years or older.\n* Utilize a wood stove as the primary heating source.\n* Capable and willing to record symptom data and wood stove usage data, as well as complete pulmonary function testing (i.e., spirometry).\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02240069', 'acronym': 'EldersAIR', 'briefTitle': 'Wood Smoke Interventions in Native American Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Montana'}, 'officialTitle': 'Residential Wood Smoke Interventions Improving Health in Native American Populations', 'orgStudyIdInfo': {'id': 'IRB 218-12'}, 'secondaryIdInfos': [{'id': 'R01ES022583', 'link': 'https://reporter.nih.gov/quickSearch/R01ES022583', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education (Tx1)', 'description': 'Education on best burn practices', 'interventionNames': ['Behavioral: Education (Tx1)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air Filtration Unit Treatment (Tx2)', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.', 'interventionNames': ['Device: Air Filtration Unit Treatment (Tx2)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Intervention (Tx3)', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.', 'interventionNames': ['Device: Placebo Intervention (Tx3)']}], 'interventions': [{'name': 'Education (Tx1)', 'type': 'BEHAVIORAL', 'description': 'Education on best burn practices', 'armGroupLabels': ['Education (Tx1)']}, {'name': 'Air Filtration Unit Treatment (Tx2)', 'type': 'DEVICE', 'description': 'A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove', 'armGroupLabels': ['Air Filtration Unit Treatment (Tx2)']}, {'name': 'Placebo Intervention (Tx3)', 'type': 'DEVICE', 'description': 'A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.', 'armGroupLabels': ['Placebo Intervention (Tx3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59812', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'University of Montana', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}], 'overallOfficials': [{'name': 'Curtis W Noonan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Montana'}, {'name': 'Annie Belcourt, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Montana'}, {'name': 'Tony J Ward, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Montana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Montana', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor', 'investigatorFullName': 'Curtis Noonan', 'investigatorAffiliation': 'University of Montana'}}}}