Can Work be Organized to Become More Health Promoting for Employees in Home Care Services? (GoldiCare)

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.

Study Overview

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

Interventional

Enrollment (Actual)

131

Phase

  • 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

    • Trøndelag
      • Trondheim, Trøndelag, 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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

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: 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.

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).
7 days during baseline measurements, 7 days during post measurements
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).
7 days during baseline measurements, 7 days during post measurements

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.
7 days during baseline measurements, 7 days during post measurements

Collaborators and Investigators

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

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)

August 22, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared with other researchers in my research group but not with any databases or researchers from other groups.

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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