Occupational ExposureGoldiCareNCT05487027
Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?
A study testing Goldilocks work principle in people with Occupational Exposure and Musculoskeletal Pain, run by Norwegian University of Science and Technology at 11 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure, Musculoskeletal Pain, Work-related Injury
- What is being tested?
- Goldilocks work principle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 11 sitesNorway
- Study dates
- 22 Aug 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Physically incapable of performing day to day tasks.
- Any illness during the measurement week
- Pregnancy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Norway11 sites
Bergheim hjemmetjeneste
Trondheim, Trøndelag
Heimdal Hjemmetjeneste
Trondheim, Trøndelag
Klæbu hjemmetjeneste
Trondheim, Trøndelag
Lade hjemmetjeneste
Trondheim, Trøndelag
Nidarvoll hjemmetjeneste
Trondheim, Trøndelag
Nidelven hjemmetjeneste
Trondheim, Trøndelag
Saupstad hjemmetjeneste
Trondheim, Trøndelag
Spongdal hjemmetjeneste
Trondheim, Trøndelag
Strinda Hjemmetjeneste
Trondheim, Trøndelag
Strindheim hjemmetjeneste
Trondheim, Trøndelag
Valentinlyst hjemmetjeneste
Trondheim, Trøndelag
About this study
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.
Read the 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.
- Conditions
- Occupational Exposure, Musculoskeletal Pain, Work-related Injury, Low Back Pain, Shoulder Pain, Neck Pain
- Being tested
- Goldilocks work principle
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain, Shoulder Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goldilocks work principleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Goldilocks work principle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
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.
Measured: 7 days during baseline measurements, 7 days during post measurements
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.
Measured: 7 days during baseline measurements, 7 days during post measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start22 Aug 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration, Trondheim Kommune
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487027
- Sponsor's protocol ID
- 315556
- Acronym
- GoldiCare
- Status last verified
- Jun 2023
- First submitted
- 3 Aug 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers in my research group but not with any databases or researchers from other groups.
Publications
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.
PubMed 39773460Lohne 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.
PubMed 36476502
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?
- ClinicalTrials.gov ID
- NCT05487027
- Acronym / sponsor ID
- GoldiCare / 315556
- Conditions
- Occupational Exposure, Musculoskeletal Pain, Work-related Injury, Low Back Pain, Shoulder Pain, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration, Trondheim Kommune
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Goldilocks work principleIntroduce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Physically incapable of performing day to day tasks.
- Any illness during the measurement week
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goldilocks work principleUsing 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. | Behavioural | Intervention |
Primary outcome
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).
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).
2 secondary outcomes
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
Between group changes in fatigue at end of shift
Time frame: 7 days during baseline measurements, 7 days during post measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 39773460Lohne 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.
- Derived from this study: PubMed 36476502Lohne 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldilocks work principle in people with Occupational Exposure and Musculoskeletal Pain, run by Norwegian University of Science and Technology at 11 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.