- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487027
Can Work be Organized to Become More Health Promoting for Employees in Home Care Services? (GoldiCare)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trøndelag
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Trondheim, Trøndelag, Norway
- Bergheim hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Heimdal Hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Klæbu hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Lade hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Nidarvoll hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Nidelven hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Saupstad hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Spongdal hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Strinda Hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Strindheim hjemmetjeneste
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Trondheim, Trøndelag, Norway
- Valentinlyst hjemmetjeneste
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
This arm will have no intervention or instructions from researchers.
Participants in this arm will perform their work planning as normal.
|
|
|
Experimental: Intervention
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between group changes in musculoskeletal pain in the neck and shoulder from pre to post measurement
Time Frame: 7 days during baseline measurements, 7 days during post measurements
|
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).
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7 days during baseline measurements, 7 days during post measurements
|
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in musculoskeletal pain in the lower back from pre to post measurement
Time Frame: 7 days during baseline measurements, 7 days during post measurements
|
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).
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7 days during baseline measurements, 7 days during post measurements
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between group changes in the composition of time spent standing, arms elevated and trunk inclined
Time Frame: 7 days during baseline measurements, 7 days during post measurements
|
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.
|
7 days during baseline measurements, 7 days during post measurements
|
|
Between group changes in fatigue at end of shift
Time Frame: 7 days during baseline measurements, 7 days during post measurements
|
The difference between intervention and control group from pre- to post-measurements in how fatigued the workers were at the end of the shift.
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7 days during baseline measurements, 7 days during post measurements
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 315556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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