Can Work be Organized to Become More Health Promoting for Employees in Home Care Services? (GoldiCare)
Primary Purpose
Occupational Exposure, Musculoskeletal Pain, Work-related Injury
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Goldilocks work principle
Sponsored by
About this trial
This is an interventional prevention trial for Occupational Exposure
Eligibility Criteria
Inclusion Criteria:
- Home care worker in one of the included home care units in Trondheim municipality.
- More than or equal to 50% working position at the home care unit.
Exclusion Criteria:
- Physically incapable of performing day to day tasks.
- Any illness during the measurement week
- Pregnancy
Sites / Locations
- Bergheim hjemmetjeneste
- Heimdal Hjemmetjeneste
- Klæbu hjemmetjeneste
- Lade hjemmetjeneste
- Nidarvoll hjemmetjeneste
- Nidelven hjemmetjeneste
- Saupstad hjemmetjeneste
- Spongdal hjemmetjeneste
- Strinda Hjemmetjeneste
- Strindheim hjemmetjeneste
- Valentinlyst hjemmetjeneste
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
This arm will have no intervention or instructions from researchers. Participants in this arm will perform their work planning as normal.
Introduce a deliberate variation between workers in how much they care for physically strenuous users. Some workers may receive more strenuous work compared to before, some less.
Outcomes
Primary Outcome Measures
Between group changes in musculoskeletal pain in the neck and shoulder from pre to post measurement
The workers will rate their musculoskeletal pain in the neck and shoulder area after each working day for a week. The measurement will be repeated at the end of the intervention to assess any changes in the experience of musculoskeletal pain. The question assessing musculoskeletal pain in shoulder and neck area is phrased as "How much pain did you have in your shoulder/neck at the end of this working day?" (Translated from Norwegian).
in musculoskeletal pain in the lower back from pre to post measurement
The workers will rate their musculoskeletal pain in the lower back after each working day for one week. The measurement will be repeated at the end of the intervention to assess any changes in the experience of musculoskeletal pain. The question assessing musculoskeletal pain in the lower back area is phrased as "how much pain did you have in your lower back at the end of the working day?" (Translated from Norwegian).
Secondary Outcome Measures
Between group changes in the composition of time spent standing, arms elevated and trunk inclined
The difference in physical behavior composition from baseline measurements to post measurements between control and intervention group. The specific variables will be time spent standing, arms elevated, and trunk inclined.
Between group changes in fatigue at end of shift
The difference between intervention and control group from pre- to post-measurements in how fatigued the workers were at the end of the shift.
Full Information
NCT ID
NCT05487027
First Posted
August 3, 2022
Last Updated
June 5, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Labour and Welfare Administration, Trondheim Kommune
1. Study Identification
Unique Protocol Identification Number
NCT05487027
Brief Title
Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?
Acronym
GoldiCare
Official Title
Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Labour and Welfare Administration, Trondheim Kommune
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a two-group, cluster randomized controlled trial designed to assess a health promoting intervention in the home care sector. The intervention aims to evenly distribute the patients requiring high levels of demanding care across all workers on the units, which may lower the working strain and thus the incidence of musculoskeletal pain. The two groups in the study will be a control group and an intervention group. The intervention will last for approximately 4 months.
Detailed Description
This is a two-group cluster randomized controlled trial to compare an organizational intervention to control. The home care units will be treated as clusters to avoid contamination within units.
Control group: No intervention, their work will continue as usual without any instructions from researchers.
Intervention group: The intervention will consist of the operational managers distributing the physically strenuous shifts evenly between the workers in each home care unit. This will be achieved using a tool developed in Microsoft Excel which gives an overview over how much strain we expect each shift to have and gives a score on how well the operational manager distributes the strain between employees.
The intervention will last for approximately 4 months, depending on duration of pre and post measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Exposure, Musculoskeletal Pain, Work-related Injury, Low Back Pain, Shoulder Pain, Neck Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals are grouped in clusters, where the clusters are the home care units in Trondheim. Half of the units will be randomized to control, half will be randomized to intervention. All units will be randomized at the same time.
Masking
None (Open Label)
Masking Description
No masking will be possible as the home care units will have an integral part in applying the intervention. The investigators will need to have control over the units in intervention arm as they may need to assist in the early stages of intervention.
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will have no intervention or instructions from researchers. Participants in this arm will perform their work planning as normal.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Introduce a deliberate variation between workers in how much they care for physically strenuous users. Some workers may receive more strenuous work compared to before, some less.
Intervention Type
Behavioral
Intervention Name(s)
Goldilocks work principle
Intervention Description
Using the Goldilocks work principle we have tried to find the "just right" distribution of physical strain in the home care sector. This is an intervention to test if it possible to distribute the physical strain experienced in the home care sector in a way that may be more health promoting for the workers.
Primary Outcome Measure Information:
Title
Between group changes in musculoskeletal pain in the neck and shoulder from pre to post measurement
Description
The workers will rate their musculoskeletal pain in the neck and shoulder area after each working day for a week. The measurement will be repeated at the end of the intervention to assess any changes in the experience of musculoskeletal pain. The question assessing musculoskeletal pain in shoulder and neck area is phrased as "How much pain did you have in your shoulder/neck at the end of this working day?" (Translated from Norwegian).
Time Frame
7 days during baseline measurements, 7 days during post measurements
Title
in musculoskeletal pain in the lower back from pre to post measurement
Description
The workers will rate their musculoskeletal pain in the lower back after each working day for one week. The measurement will be repeated at the end of the intervention to assess any changes in the experience of musculoskeletal pain. The question assessing musculoskeletal pain in the lower back area is phrased as "how much pain did you have in your lower back at the end of the working day?" (Translated from Norwegian).
Time Frame
7 days during baseline measurements, 7 days during post measurements
Secondary Outcome Measure Information:
Title
Between group changes in the composition of time spent standing, arms elevated and trunk inclined
Description
The difference in physical behavior composition from baseline measurements to post measurements between control and intervention group. The specific variables will be time spent standing, arms elevated, and trunk inclined.
Time Frame
7 days during baseline measurements, 7 days during post measurements
Title
Between group changes in fatigue at end of shift
Description
The difference between intervention and control group from pre- to post-measurements in how fatigued the workers were at the end of the shift.
Time Frame
7 days during baseline measurements, 7 days during post measurements
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Home care worker in one of the included home care units in Trondheim municipality.
More than or equal to 50% working position at the home care unit.
Exclusion Criteria:
Physically incapable of performing day to day tasks.
Any illness during the measurement week
Pregnancy
Facility Information:
Facility Name
Bergheim hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Heimdal Hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Klæbu hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Lade hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Nidarvoll hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Nidelven hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Saupstad hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Spongdal hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Strinda Hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Strindheim hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
Facility Name
Valentinlyst hjemmetjeneste
City
Trondheim
State/Province
Trøndelag
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared with other researchers in my research group but not with any databases or researchers from other groups.
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Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?
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