NCT05487027

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

August 3, 2022

Last Update Submit

June 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Between group changes in the composition of 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

    7 days during baseline measurements, 7 days during post measurements

Study Arms (2)

Control

NO INTERVENTION

This arm will have no intervention or instructions from researchers. Participants in this arm will perform their work planning as normal.

Intervention

EXPERIMENTAL

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.

Behavioral: Goldilocks work principle

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Physically incapable of performing day to day tasks.
  • Any illness during the measurement week
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Bergheim hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Heimdal Hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Klæbu hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Lade hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Nidarvoll hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Nidelven hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Saupstad hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Spongdal hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Strinda Hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Strindheim hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Valentinlyst hjemmetjeneste

Trondheim, Trøndelag, Norway

Location

Related Publications (2)

  • Lohne FK, Fimland MS, Palarea-Albaladejo J, Mathiassen SE, Holtermann A, Redzovic S. Can home care work be organized to promote musculoskeletal health for workers? Results from the GoldiCare cluster randomized controlled trial. BMC Health Serv Res. 2025 Jan 7;25(1):41. doi: 10.1186/s12913-024-12133-2.

  • Lohne FK, Fimland MS, Holtermann A, Mathiassen SE, Fischer H, Gellein TM, Redzovic S. Can home care work be organized to promote musculoskeletal health for workers? Study protocol for the Norwegian GoldiCare cluster randomized controlled trial. BMC Health Serv Res. 2022 Dec 7;22(1):1490. doi: 10.1186/s12913-022-08916-0.

MeSH Terms

Conditions

Musculoskeletal PainLow Back PainShoulder PainNeck Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainArthralgiaJoint Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

August 22, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

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

Locations