NCT06534203

Brief Summary

Providing care to residents and patients significantly contributes to work-related injuries among healthcare personnel, particularly those responsible for transferring and handling residents, who face a higher risk of injury due to the physical demands of their work and other environmental factors. The purpose of this project is to better understand the daily work requirements, identify their physical demands, and assess injury risk of caregivers. Data will be collected using a new pen-and-paper-based ergonomic surveying tool, a series of questionnaires, and measurements of physiological demands such as heart rate and galvanic skin response. Collecting this data will enable the investigators and others to create new interventions better tailored to this working population, with a focus on injury prevention. These interventions may include warm-up routines, stretching exercises, training programs, and/or technological advancements.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 3, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

Musculoskeletal InjuriesHealthcarePatient HandlingNursing HomesInjury Prevention

Outcome Measures

Primary Outcomes (9)

  • Pen and Paper Ergonomic Tool - Part 1A : "The caregiver did NOT use any tools or aids while performing the following transfer tasks"

    Each participant will be observed throughout an entire workday using a new pen-and-paper-based ergonomic tool developed in the lab. This assessment tool (see Appendix A) is a comprehensive document designed to record the various physical tasks and demands encountered during a typical workday for caregivers in long-term care facilities. The tool was developed based on standardized task analysis tools widely used in ergonomic practices (OHCOW, 2023). Part 1A of this tool will identify the number of transfers performed by caregivers during a workday, specifying the frequency (number of times this task was performed) and time (seconds) of each type of transfer WITHOUT the use of tools or aids.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 1B : "The caregiver used tools and/or aids while performing the following transfer tasks"

    Part 1B of this tool will identify the number of transfers performed by caregivers during a workday, specifying the frequency (number of times this task was performed) and time (seconds) for each type of transfer WITH the use of tools or aids.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 1C: "Tools used for resident transfers"

    The purpose of Part 1C is to determine how many transfers each type of equipment was used for by caregivers on a workday. It identifies the frequency of use for both mechanical and non-mechanical tools.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 2A: "Number of resident handling in Bed"

    Part 2A of this tool will identify the number of resident handling tasks performed by caregivers in bed during a workday, specifying the frequency (i.e., the number of times this task was performed). This section is also subdivided to identify not only the number of manipulations but also the types of manipulations performed.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 2B: "Number of resident handling in Wheelchair - Sitting"

    Part 2B of this tool will identify the number of resident handling tasks performed by caregivers in a wheelchair or sitting position during a workday, specifying the frequency (i.e., the number of times this task was performed). This section is also subdivided to identify not only the number of manipulations but also the types of manipulations performed.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 3: "Motor tasks - Housework - Sanitary"

    Sanitary services and needs, such as bending down to clean or pick up objects, can expose caregivers to risks of WRMSIs, especially if they are in a vulnerable position while performing motor tasks. Assisting residents with hygiene care and clothing changes can also vary in terms of time and complexity, which can present challenges for caregivers and increase their risk of injury. This section of the tool will provide an overview of the frequency with which these types of motor tasks are performed during a workday.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 4: "Time spent under different type of behavior"

    Extended periods of standing and walking can have significant long-term effects on health. Therefore, this section is crucial as it allows for the recording of the approximate time (in minutes) spent on various activities, such as standing, sitting, and walking, throughout a workday.

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 5: "Additional information"

    This section of the tool will identify several important factors that can influence the risk of injury to caregivers, including the total time worked during the shift, rest periods, and the longest continuous period worked without rest (in minutes).

    One experimental session (8 to 12 hours)

  • Pen and Paper Ergonomic Tool - Part 6: "Field observations"

    This section of the tool will be used to record any additional behaviors, factors, or obstacles that may increase the risk of injury to caregivers and that have not been covered elsewhere in the tool. It will serve as a journal for the investigators to track valuable information during data collection.

    One experimental session (8 to 12 hours)

Secondary Outcomes (1)

  • Rate of Perceived Discomfort Questionnaire (RPD-Q)

    One experimental session (8 to 12 hours)

Other Outcomes (7)

  • Health and Lifestyle Questionnaire - Part 1A : "Lifestyle Habits"

    One experimental session (8 to 12 hours)

  • Health and Lifestyle Questionnaire - Part 1B : "Lifestyle Habits"

    One experimental session (8 to 12 hours)

  • Health and Lifestyle Questionnaire - Part 1C : "Lifestyle Habits"

    One experimental session (8 to 12 hours)

  • +4 more other outcomes

Interventions

In this study, there will be no intervention, instead, it will be an observational study aimed at identifying the specific physical demands of caregivers working in long-term care facilities. This information will inform future interventions that can help reduce the occurrence of work-related musculoskeletal injuries.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Full time caregivers working in a long term care facility responsable of resident care in New-Brunswick, Canada

You may qualify if:

  • Full-time caregivers
  • Caregivers responsible for the care and handling of residents
  • Aged 19 or over

You may not qualify if:

  • Part-time caregivers
  • Caregivers not responsible for residents care and handling
  • Caregivers under 19 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Moncton

Moncton, New Brunswick, E1A 3E9, Canada

RECRUITING

Study Officials

  • Michelle Cardoso, PhD

    Université de Moncton

    PRINCIPAL INVESTIGATOR
  • Wayne Albert, PhD

    University of New Brunswick

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Dube, B. Sc (2025)

CONTACT

Michelle R Cardoso, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2024

First Posted

August 2, 2024

Study Start

July 25, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations