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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05487027
Other study ID # 315556
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date May 15, 2023

Study information

Verified date June 2023
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date May 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Goldilocks work principle
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.

Locations

Country Name City State
Norway Bergheim hjemmetjeneste Trondheim Trøndelag
Norway Heimdal Hjemmetjeneste Trondheim Trøndelag
Norway Klæbu hjemmetjeneste Trondheim Trøndelag
Norway Lade hjemmetjeneste Trondheim Trøndelag
Norway Nidarvoll hjemmetjeneste Trondheim Trøndelag
Norway Nidelven hjemmetjeneste Trondheim Trøndelag
Norway Saupstad hjemmetjeneste Trondheim Trøndelag
Norway Spongdal hjemmetjeneste Trondheim Trøndelag
Norway Strinda Hjemmetjeneste Trondheim Trøndelag
Norway Strindheim hjemmetjeneste Trondheim Trøndelag
Norway Valentinlyst hjemmetjeneste Trondheim Trøndelag

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Norwegian Labour and Welfare Administration, Trondheim Kommune

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 7 days during baseline measurements, 7 days during post measurements
Primary 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). 7 days during baseline measurements, 7 days during post measurements
Secondary 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. 7 days during baseline measurements, 7 days during post measurements
Secondary 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. 7 days during baseline measurements, 7 days during post measurements
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