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Copen-SCALE: Scaling up an effective intervention to childcare institutions in Copenhagen

Copen-SCALE: Scaling up an effective intervention to childcare institutions in Copenhagen – a stepped wedge type II hybrid effectiveness-implementation trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14831585
Enrollment
74
Registered
2024-01-04
Start date
2024-01-08
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Workplace – Childcare institutions Other

Interventions

This study is an evaluation of an intervention being implemented by working environment consultants from Copenhagen municipality in childcare institutions (i.e. the intervention is not delivered by th

Sponsors

National Research Centre for the Working Environment
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All employees directly involved in childcare at the participating institutions 2. Consent to participate in the scientific evaluation

Exclusion criteria

Exclusion criteria: Non-permanent employees.

Design outcomes

Primary

MeasureTime frame
Pain-related sickness absence within the last three months measured using a questionnaire at baseline and follow-up (approx. 6-8 months after the intervention start). Participants will be asked to answer the following categories: 0 days, 1-5 days, 6-10 days, 11-15 days and above 15 days. Evaluation of implementation The primary outcome for implementation will be the fidelity of the intervention. Fidelity will be measured as: 1. Adherence, defined as the proportion of program components that were delivered compared to the number prescribed in the intervention protocol, measured using a short questionnaire survey for the consultants after completing each intervention activity 2. Exposure, defined as the number of sessions, measured using the consultant’s intervention logs registered throughout the study period 3. Quality of delivery measured using the following questions for the consultants after completing each intervention activity: 3.1. “Regarding today, to which extent have you contributed to… [To a very large extent (100)/to a large extent (100)/somewhat (50)/to a small extent (0)/to a very small extent (0)] ...the participants’ commitment and motivation? ..ensuring the employees’ participation in the activity? ..adapting the activity to the needs of the participants? ..maintaining the participants’ attention? 3.2. Suppose that your performance, at its best, is equal to 10 points. How would you rate your performance today? [0–10 (0 = not capable to perform; 10 = best performance) (0–4 were scored 0, 5–7 were scored 50, 8–10 were scored 100)] 4. Participant responsiveness measured using the following question for the consultants after completing each intervention activity: 4.1. To which extent are the participants committed and motivated? [To a very large extent (100)/to a large extent (100)/somewhat (50)/to a small extent (0)/to a very small extent (0)]

Secondary

MeasureTime frame
The following secondary outcome measures will be assessed at baseline and follow-up (approx. 6-8 months): 1. Frequency of pain in any body region (except the head) within the last three months measured using a questionnaire 2. Worst pain in neck/shoulder and lower back within the last three months measured using a Numeric Pain Rating Scale (NPRS) from 0-10 3. Pain duration within the last seven days measured using a modified version of the Nordic Musculoskeletal Questionnaire (NMQ) 4. Average pain intensity in neck/shoulder and lower back within the last seven days measured using an NPRS from 0-10 (NMQ) 5. Pain-related work interference measured using a modified version of the NMQ 6. Pain-related health literacy levels measured using a modified version of the Health Literacy Questionnaire (HLQ) 7. Fear-avoidance beliefs measured using two questions from the Örebro Musculoskeletal Pain Questionnaire (OMPQ) 8. Perceived physical exertion at work measured using the BORG-10 Rating of Perceived Exertion (RPE) scale 9. Meaning in work measured using a question from the Danish Psychosocial Questionnaire. Evaluation of cost-effectiveness A cost-effectiveness evaluation will be made with the following outcomes: 1. Sickness absence will be collected from workplace registers. Data will be collected from one year before the intervention (2023) until the last childcare institution has finished the intervention (in 2027). 2. Productivity costs will be measured using a modified version of the iMTA Productivity Cost Questionnaire (iPCQ) at baseline and follow-up. Costs will be collected during the implementation of the intervention and will include: 2.1. Staff time: Employees’ and managers’ participation in intervention activities, measured using registration of participation in activities that are not directly part of daily work (e.g. a workshop/meeting for planning the activities) 2.2. Employees’ and managers’ costs will subsequently be valued based on their average yearly g

Countries

Denmark

Contacts

Public ContactLine;Ole Henning Lindberg;Sørensen

;

lil@nfa.dk;ohs@nfa.dk+4541823399;+45 (0)21692387

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026