- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04378348
Prevention Program to Reduce Injury Disparities Among Latino Day Laborers
May 4, 2020 updated by: Maria E Fernandez-Esquer, The University of Texas Health Science Center, Houston
The purpose of this study is to Identify intervention priorities using a corner-based needs assessment to document occupational and psychosocial risk and protective factors that increase Latino day laborers(LDL) risk for injury and to design a culturally responsive and context appropriate Occupational Safety and Health Administration (OSHA) 10-based safety intervention that also addresses psychosocial risks to reduce LDL injuries and collaboratively pilot a corner-level intervention and conduct an evaluation to assess the safety program's feasibility and acceptability as determined by the extent to which we can recruit, retain and follow-up LDL over the course of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Latino
- identified at a "corner" located in the Houston metropolitan area
- currently looking for work at a corner
Exclusion Criteria:
- not of Hispanic/Latino background
- being unable to participate in the survey due to alcohol or drug use impairment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Motivational Interview
|
The MI dialogue will begin with an introduction where the LDL is asked about the type of work he does and his concerns regarding dangers in his workplace.
This will be followed by a decisional balance exercise where the interviewer will engage the LDL in thinking about the pros and cons of taking jobs with many dangers and jobs with less dangers.
Using a figure of a traffic light, the interviewer will proceed to measure how important it is for the LDL to reduce the dangers in his work place and identify his reasons for its importance.
Next, the interviewer will measure the LDL's level of confidence in his ability to reduce the dangers in his workplace.Together, they will develop a plan to reduce the dangers in the workplace.
Finally, the interviewer will summarize the safety plan to the LDL and will explain that the team will return to the corner in one month to see how the implementation of his plan went and to conduct a post-test survey
|
EXPERIMENTAL: Participatory Group Activity
|
Participants will view a figure of a pyramid representing the steps they can take to reduce the dangers in their workplace and the things that are in their control to reduce the dangers followed by pictures of dangerous work environments.
They will be engaged in hazard identification and situational awareness by identifying and sharing out loud the dangers they see in the picture.
Participants will also engage in problem solving by coming up with strategies they could use to reduce the dangers they identified in the picture and will measure their level of confidence in their ability to implement the strategies they have come up with, should they find themselves in a similar work situation.
The group facilitator will summarize what the group has said and what they have learned during the group activity and will ask participants to voluntarily make a personal promise to take concrete steps to reduce the dangers at their work.
|
PLACEBO_COMPARATOR: Control Condition
|
At control corner sites, we will recruit another 35 Latino day laborer participants.Participants in the control group will receive OSHA pamphlets with standard workplace safety and health information.
During our needs assessment survey, we collected information regarding workrelated injuries.
Results from this survey indicate the following 4 categories are the highest cause of injury among surveyed Latino day laborers: 1) moving heavy objects, 2) falls, 3) being struck by falling or lying objects, and 4) serious cuts.
The OSHA materials that will be distributed to participants will include safety and health information regarding these four topics.
Furthermore, given that the LDL are continuously exposed to the sun (e.g., at the corner while waiting for work, at work, and on their way to and from work), heat exposure will also be included in the OSHA materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exposure to dangers in the workplace as assessed by a questionnaire
Time Frame: Baseline
|
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions.
Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
|
Baseline
|
Exposure to dangers in the workplace as assessed by a questionnaire
Time Frame: 1 month
|
The questionnaire asks how often the participant has worked with asbestos, lead paint, Clorox, oil paint, solvents (such as paint thinner), insecticides (such as Raid), glue or adhesive, equipment that creates dust, gasoline or diesel, and cleaning solutions.
Each of 10 items on the questionnaire are rated as 1 Never, 2 Sometimes, 3 Many Times, or 4 All the Time, with a total score ranging from 10 to 40, with higher scores indicating greater exposure to dangers in the workplace.
|
1 month
|
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Time Frame: Baseline
|
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
|
Baseline
|
Number of participants who had a severe injury or illness in the past month related to their job as a day laborer
Time Frame: 1 month
|
Severe injury or illness is defined as an injury or illness where the participant missed work because o the injury or illness, the participant should not have gone to work but you did anyway, or the participant had to receive medical attention from a doctor or a clinic.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Time Frame: Baseline
|
Baseline
|
Number of participants who had anything happen to them at work in the past month that almost caused them to be injured or made them feel that they could have been injured
Time Frame: 1 month
|
1 month
|
Feasibility and acceptability as indicated by number of participants recruited to the study
Time Frame: Baseline
|
Baseline
|
Feasibility and acceptability as indicated by number of participants retained in the study
Time Frame: 1 month
|
1 month
|
Feasibility and acceptability as indicated by number of participants who completed the one month follow up
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Fernandez-Esquer, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 26, 2015
Primary Completion (ACTUAL)
November 3, 2015
Study Completion (ACTUAL)
December 8, 2015
Study Registration Dates
First Submitted
May 4, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (ACTUAL)
May 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 4, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-12-0818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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