Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04234802
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2020-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018882', 'term': 'Heat Stress Disorders'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a parallel, comparison, group intervention study to evaluate the effectiveness of a multi-level Heat Education and Awareness Tools (HEAT) intervention, consisting of worker training and a supervisor heat awareness application, on reducing adverse heat health effects in agricultural workers across a growing season.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heat-related Illness Symptoms', 'timeFrame': 'Approximately three months', 'description': "Heat symptoms will be assessed using a short survey conducted in Spanish or English that includes questions about heat-related illness symptoms experienced over the past week. Participants will select one or more symptoms (or select 'none') from a list."}, {'measure': 'Heat Strain', 'timeFrame': 'Approximately three months', 'description': "The body's physiological response to heat stress. Core body temperature (degrees C) will be estimated using personal baseline temperature and continuous heart rate during work shifts on several days."}], 'secondaryOutcomes': [{'measure': 'Pre/post Knowledge Assessment', 'timeFrame': 'Approximately three months', 'description': 'Short set of multiple-choice questions based on key points addressed in the one-hour training on recognition, treatment, and prevention of heat-related illness.'}, {'measure': 'Pre/post Supervisor Survey', 'timeFrame': 'Approximately three months', 'description': 'Short set of interview questions to learn about heat safety practices and utilization of the HEAT awareness application for intervention group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heat Stress Disorders']}, 'referencesModule': {'references': [{'pmid': '36104813', 'type': 'DERIVED', 'citation': 'Chavez Santos E, Spector JT, Egbert J, Krenz J, Sampson PD, Palmandez P, Torres E, Blancas M, Carmona J, Jung J, Flunker JC. The effect of the participatory heat education and awareness tools (HEAT) intervention on agricultural worker physiological heat strain: results from a parallel, comparison, group randomized study. BMC Public Health. 2022 Sep 15;22(1):1746. doi: 10.1186/s12889-022-14144-2.'}, {'pmid': '35345983', 'type': 'DERIVED', 'citation': 'Marquez D, Krenz JE, Chavez Santos E, Torres E, Palmandez P, Sampson PD, Blancas M, Carmona J, Spector JT. The Effect of Participatory Heat Education on Agricultural Worker Knowledge. J Agromedicine. 2023 Apr;28(2):187-198. doi: 10.1080/1059924X.2022.2058667. Epub 2022 Apr 17.'}, {'pmid': '34169175', 'type': 'DERIVED', 'citation': 'Krenz J, Santos EC, Torres E, Palmandez P, Carmona J, Blancas M, Marquez D, Sampson P, Spector JT. The multi-level heat education and awareness tools [HEAT] intervention study for farmworkers: Rationale and methods. Contemp Clin Trials Commun. 2021 Jun 8;22:100795. doi: 10.1016/j.conctc.2021.100795. eCollection 2021 Jun.'}]}, 'descriptionModule': {'briefSummary': "The project's primary aim is to evaluate the effectiveness of a multi-level heat prevention approach in reducing adverse heat health effects in outdoor agricultural workers\n\nThe secondary aims are to:\n\n* Test the effectiveness of an individual-level training component designed to reduce adverse heat health effects in outdoor agricultural workers\n* Evaluate the effectiveness of a workplace supervisor-level heat awareness application intended to support supervisor decisions to reduce the risk of workers experiencing adverse heat health effects"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Speak English or Spanish, live in same dwelling and work at same farm for the season, farm where participant works must agree to collaborate\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT04234802', 'briefTitle': 'A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Multi-Level Approach to Heat-Related Illness Prevention in Agricultural Workers', 'orgStudyIdInfo': {'id': 'STUDY00000238'}, 'secondaryIdInfos': [{'id': '2U54OH007544-16', 'link': 'https://reporter.nih.gov/quickSearch/2U54OH007544-16', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HEAT intervention group', 'description': 'Workers in the intervention group will receive the HEAT training, and supervisors in the intervention group will receive the HEAT awareness application and training on how to use it.', 'interventionNames': ['Other: Heat Education and Awareness Tools']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison group', 'description': 'The comparison group will not be offered HEAT trainings or the HEAT awareness application. They will be offered an alternative training on another topic.'}], 'interventions': [{'name': 'Heat Education and Awareness Tools', 'type': 'OTHER', 'description': "HEAT training will be delivered to agricultural workers by research staff in this study in the spring. HEAT training uses interactive approaches to engage participants and posters with visuals. Training covers types of heat-related illness and treatments, risk factors, appropriate clothing and hydration, and keeping cool in the home and community. The HEAT awareness application was developed in collaboration with Washington State University's AgWeatherNet Program to notify supervisors signed up for the service about hot weather conditions that might increase the risk for adverse health effects for workers. The HEAT awareness application is designed to allow subscribers to select weather stations of interest and view current heat indices as well as maximum daily heat indices forecasted over the following week. This information is coupled with information about health effects and prevention of adverse heat health effects. Materials are provided in English and Spanish.", 'armGroupLabels': ['HEAT intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Farms (confidential)', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}], 'overallOfficials': [{'name': 'June T Spector, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available after primary analyses are completed, approximately 1-2 years after data collection is completed. Data will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'De-identified IPD will be available upon reasonable request and/or will be available in a publicly accessible data repository. IPD will include general demographic variables and summary physiological measurements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Occupational Safety and Health (NIOSH/CDC)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Environmental and Occupational Health Sciences; Department of Medicine', 'investigatorFullName': 'June Spector', 'investigatorAffiliation': 'University of Washington'}}}}