Test@Work Study: Evaluation of Attitudes and Uptake Within Employee Health Checks in the Construction Industry (Test@Work)

September 13, 2021 updated by: Holly Blake, University of Nottingham

Test@Work: Evaluation of Attitudes and Uptake Within Employee Health Checks in the Construction Industry

This project is called Test@Work. In this project the investigators will offer general health checks and tailored health advice to up to 650 employees in the construction industry at sites across the East Midlands. The investigators will assess reach and uptake, and evaluate the views and perceptions of employees, managers and the delivery team. Health checks will include Body Mass Index (BMI; weight/height), waist-to-hip ratio, blood pressure, mental health screen, sexual health consultation and an opt-in rapid screening test for human immunodeficiency virus (HIV). Employees will be provided with a resource pack with information and signposting around physical activity, diabetes risk, diet, and musculoskeletal health. A digital resource providing information and signposting about workplace health screening and HIV testing will be developed and provided to managers at the participating worksites 2 weeks before their health check event.

Employees will be offered an additional text messaging service involving receipt of a series of messages with advice around HIV and testing alongside general health information. Employees will complete post-health check exit questionnaires and an exit interview. Managers will complete a post-event evaluation questionnaire and post-event interview. Mixed-methods evaluation will include assessment of reach, uptake, and intervention implementation processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will collect evaluation data with employees and company representatives.

Employees: will complete exit-questionnaires and be invited to a brief exit interview.

The investigators will collect by anonymous questionnaire: age, gender, country of birth, ethnicity, postcode, sexual orientation, employment status (FT/PT, permanent, agency, contract worker), reasons for attending, health perceptions, prior HIV testing history, influence of work on health, perceptions of employers provision for health and wellbeing, perceptions towards HIV testing in the workplace, range of tests undertaken, views about the workplace health check and future health intentions. Personal identifiers will not be collected and questionnaire data will not be provided to employers. Those employees who agree to be interviewed after the health check will be invited to a brief independent confidential interview with the project researcher.

Company representatives: will complete brief post-event questionnaire and be invited to post-event interview

The investigators will ask about the organisational/employee profile, their perceptions of company provision for health and wellbeing, perceptions towards the usefulness of the implementation toolkit and towards HIV testing in the workplace, method of delivery and their confidence to support employees who disclose a positive test outcome, views about the workplace health check and future implementation intentions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • Nottingham, United Kingdom, NG72HA
        • University of Nottingham

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • employee of a company in construction or related industries
  • provides informed consent

Exclusion Criteria:

  • does not speak English

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Checks
Workplace health checks - in this intervention employees can select from a range of optional health checks/tests and receive tailored health advice and a health resource pack.
Behavioral: Test@Work
Offer of a general health check including opt-in sexual health consultation and HIV testing, weight/height, Body Mass Index (BMI), blood pressure, mental health screen. Provision of tailored health advice and a resource pack with information and signposting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health check uptake
Time Frame: Rolling intervention delivery and data collection over 15 months
Percentage of employees choosing to take a workplace health check from total employee population across all sites
Rolling intervention delivery and data collection over 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
reasons for attending
Time Frame: immediately post-event
Qualitative data collected on reasons for opting in to health check
immediately post-event
perceptions of employer's provision for health and wellbeing
Time Frame: immediately post-event
Qualitative data collected on perceptions towards employer
immediately post-event
perceptions towards HIV testing in the workplace
Time Frame: immediately post-event
Qualitative data collected on employee views towards HIV testing at work
immediately post-event
range of tests undertaken
Time Frame: during the health check, and qualitative data immediately post-event
which of the optional checks/tests were taken by the employee
during the health check, and qualitative data immediately post-event
Employee demographic profile
Time Frame: At recruitment
Age, Gender, country of birth, ethnicity, postcode, sexual orientation, employment status (full-time or part-time, permanent, agency, contract worker)
At recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IN-UK-276-5347 HIV DVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators are not collecting individual health outcomes as part of this study. The primary aim is to assess uptake and reach of this workplace health checks initiative. Anonymised qualitative data can be available on reasonable request.

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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