Condition category
Musculoskeletal Diseases
Date applied
25/05/2018
Date assigned
13/07/2018
Last edited
13/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Musculoskeletal disorders (MSD) are the most common work-related health problems in Europe and Spain; in order to reduce sickness absence this is one of the greatest health challenges. Previous interventions have been developed to improve the return-to-work of employees with MSDs, but combined approaches and exhaustive evaluation are required. The objective of INTEVAL_Spain project is to evaluate the effectiveness of a multi-component intervention at the workplace to prevent and manage MSDs in workers.

Who can participate?
Adult nursing staff who work in the study units

What does the study involve?
Hospital units are randomly allocated to one of two arms. Those in the first arm receive an intervention for one year, which is made up of three components:
a) Identifying and improving the working conditions associated with the onset of MSDs
b) Diagnosis, management and support for workers with MSDs
c) Regular activities associated with health benefits

Those in the control group only receive usual care.
Participants take a series of questionnaires before the intervention, and at 6 and 12 months.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for those taking part in the study.
Where is the study run from?
1. Parc de Salut Mar (Spain)
2. Corporació Santaria Parc Tauli (Spain)

When is the study starting and how long is it expected to run for?
November 2015 to June 2019

Who is funding the study?
Carlos III Health Institute (Instituto de Salud Carlos II) (Spain)

Who is the main contact?
Mrs Mercè Soler Font (scientific)
merce.soler01@estudiant.upf.edu

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Mercè Soler Font

ORCID ID

Contact details

Dr
Aiguader
88
Barcelona
08003
Spain
+34933160876
merce.soler01@estudiant.upf.edu

Type

Public

Additional contact

Mrs Mercè Soler Font

ORCID ID

Contact details

Dr. Aiguader
88
Barcelona
08003
Spain
+34933160876
cisal@upf.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FIS FEDER/ PI14/01959

Study information

Scientific title

Evaluation of the effectiveness of a multi-component intervention at the workplace for the prevention and management of musculoskeletal disorders in nursing staff: design of a cluster-randomized controlled trial. The INTEVAL_Spain project.

Acronym

INTEVAL_Spain

Study hypothesis

An innovative multicomponent intervention at the workplace that combines primary, secondary and tertiary prevention, and health promotion, will have a positive impact on musculoskeletal health in healthcare workers by reducing the frequency and duration of MSDs and will be cost-effective for the company/hospital. Considering the prevalence of MSDs in workers as a representative indicator of the impact on health, we estimate that this multicomponent intervention will reduce this outcome by 25%.

Ethics approval

Clinical Research Ethical Committee of the Parc de Salut Mar (CEIC-Parc de Salut Mar), 14/07/2014, ref: 2014/5714/1

Study design

Two-armed cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Work related-musculoskeletal disorders and sickness absence.

Intervention

The study is designed as a two-armed cluster randomized controlled trial, with a late intervention control group where clusters are independent hospital units, and participants are the nursing staff- workers exposed to musculoskeletal risks. This study is a randomized trial, in which the employees are randomized after signing informed consent together with formal information about the study. A total of eight clusters have been selected for the randomization. The condition of being included in the intervention or the control group cannot be blinded. All clusters are Hospital Units where nurses and aids are at risk of high physical demands due to the characteristics of the patients cared for in them (dependents and semi-collaborative patients). All data collected from both groups (intervention and control groups) is anonymized before the analyses. An independent researcher assigns the clusters to the intervention or to the control group by a simple randomization stratified by center, obtaining 4 clusters in each group.

The intervention is based on the available scientific evidence and consists of three components that encompass the three levels of prevention and health promotion:
a) participatory ergonomics, to identify and improve the working conditions associated with the onset of MSDs in workers
b) case management, including early diagnosis and personalized management of workers with disabling MSDs (secondary prevention) and the adaptation and facilitation of return to work after a sickness absence episode and/or workers’ maintenance in their jobs (tertiary prevention)
c) health promotion, through activities scheduled during the second and third quarter until the end of the intervention, associated with evidence based health benefits (physical exercise, stress management, healthy eating and education on health beliefs).
The intervention group also receive care as usual, and the control group will receive only usual care of occupational health.

The intervention lasts one year, and data are collected at baseline, 6 and 12 months follow-up.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

1. Musculoskeletal self-perceived pain data are collected using the Spanish version of the Nordic Questionnaire, at baseline, 6 months and 12 months follow-up.
2. Sickness absence data are collected from one year before the intervention was implemented until the end of the intervention, and number of episodes and their duration is analyzed.

Secondary outcome measures

1. Work functioning is measured by the Work Role Functioning Questionnaire-Spanish Version at baseline, 6 and 12 months follow up.
2. Quality of life is measured by the European Questionnaire 5 Dimensions 3 Levels ( EQ-5D-3L) at baseline, 6 and 12 months follow up.
3. Preventive culture is measured by the Institute for Work & Health Organizational Performance Metric (IWH-OPM), at baseline, 6 and 12 months follow up.

Overall trial start date

01/11/2015

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Nursing staff (nurses and aides) including employees in sickness absence who work in the study units/clusters
2. Voluntarily willing to participate in the study

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

From the sample calculations, 8 clusters of 20 to 60 participants each have agreed to participate.

Participant exclusion criteria

1. Temporary staff who work at the study units only infrequently and/or for short periods
2. Employees on leave, except on sickness absence, during most of the study period

Recruitment start date

01/05/2016

Recruitment end date

01/09/2016

Locations

Countries of recruitment

Spain

Trial participating centre

Parc de Salut Mar
Barcelona
08003
Spain

Trial participating centre

Corporació Santaria Parc Taulí
Sabadell
08208
Spain

Sponsor information

Organisation

FUNDACIÓ IMIM

Sponsor details

Dr. Aiguader
88 - PRBB Building
Barcelona
08003
Spain
+34 933 160 876
salutlaboral@upf.edu

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Instituto de Salud Carlos III

Alternative name(s)

Institute of Health Carlos III, Carlos III Health Institute, ISCIII

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Funder name

Prevent Foundation - Barcelona (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in a high-impact peer reviewed journal during the period comprised from 01/09/2018 to 01/03/2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available. The study participants signed a form to give their informed consent to participate in the study. The objectives and scope of the study were specified in the form, informing that all the personal data as well as the information provided at all times would be anonymous and would only be used in the INTEVAL study.

Intention to publish date

01/03/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes