Condition category
Not Applicable
Date applied
17/06/2013
Date assigned
17/06/2013
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Work is good for health and well-being. An interesting job with good support from managers and colleagues and excellent working conditions is likely to lead to high levels of well-being. In contrast, jobs with high pace, being asked to carry out tasks which conflict with each other, low support and little guidance from managers, little control over the work and how it is carried out, bullying and injustice at work can reduce well-being and increase the risk of taking sickness absence from work. Key to maintaining and improving employee well-being is the knowledge and practice of their managers. There have been very few studies of manager training in relation to employee well-being and sickness absence. However, there have been many studies demonstrating that lack of support from managers is related to poor mental health and increased sickness absence in employees. This research involves a small study of an already developed e-learning programme for managers to be completed on-line by managers in separate modules over 12 weeks. These modules aim to help managers understand and learn how to support and value their employees, increase employees' control over their work where possible, ensure their employees are justly treated and identify and eliminate bullying. In this first study, before the main study begins, we will test whether organisations will accept the intervention (e-learning programme) and whether we can achieve high levels of recruitment to the study. We will also examine in detail the components of the e-learning intervention and whether managers stick to the programme. We will also get an initial idea of how effective the programme is in altering managers' behaviours and improving employees' wellbeing.

Who can participate?
For this study we have recruited the Cheshire and Wirral Partnership NHS Trust. The participants to be included in this study are about 40 managers and their employees.

What does the study involve?
Four departments with a total of about 400 employees within this organisation will be randomly allocated to either the managers being provided with the intervention (intervention group) or not (control group). At the beginning of the study, before the intervention, we will measure employee well-being using a questionnaire in both intervention and control groups. We will repeat this well-being measure in employees 4 months after the start of the intervention. We will study the effectiveness of the intervention. We will also check whether we can collect rates of sickness absence in this organisation to test whether the intervention reduces levels of short (less than 7 days) and medium duration (7-21 days) sickness absence. We will also evaluate whether we can collect information from the employer on whether the intervention is cost-effective in terms of reducing sickness absence. As this is a small study we will also carry out qualitative in-depth interviews and focus groups as part of the initial evaluation of the e-learning programme. This will involve focus groups and interviews with the managers after the intervention to assess whether managers found it helpful or not and to find out if there are ways in which it could be improved. We will also include in-depth interviews with senior managers and Human Resources personnel to try to understand their perspective on the intervention. We will also have focus groups and interviews with employees to see if they feel the programme for managers has had any impact on them.

What are the possible benefits and risks of participating?
There are few risks associated with this intervention; the developer of the e-learning programme will train facilitators to introduce the managers to the intervention and the facilitators will provide weekly email and telephone support for managers to deal with any issues raised by the intervention. We will maintain strict confidentiality with the employee data and will not report any individual data back to the organisation. We have an expert team to run the study. The benefits of the intervention will be to improve employees' (and indirectly, managers') levels of wellbeing. It is anticipated that managers will be facilitated to be more effective and supportive and that this will have benefits for the employees in terms of subjective wellbeing and reduced sickness absence. A positive effect in decreasing rates of sickness absence will be to increase productivity and sustain employee confidence, and potentially improve the efficiency, and productivity, of the organisations involved.

Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
The study started in June 2013 and will run for about 18 months

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Stephen Stansfeld
s.a.stansfeld@qmul.ac.uk

Trial website

http://www.gemstudy.net

Contact information

Type

Scientific

Primary contact

Ms Doris Lanz

ORCID ID

Contact details

Barts and The London Queen Mary's School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom
-
d.lanz@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14578

Study information

Scientific title

Pilot study of a randomised trial of a guided E-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence

Acronym

GEM

Study hypothesis

The overall aim of the main study is to evaluate whether an e-learning health promotion intervention using management standards applied by managers will improve employees' well-being and reduce sickness absence in clusters selected from an organisation compared to similar clusters in the same organisation where it has not been applied. In this pilot study, we aim to test the acceptability of the trial, feasibility of recruitment, the components of the intervention, adherence and likely effectiveness of the intervention within separate clusters of the same organisation.

Ethics approval

Queen Mary Research Ethics Committee, first MREC approval date 28/03/2013, ref: QMREC2013/10

Study design

Single-site cluster randomised single-blinded controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Health Services Research, Mental health

Intervention

Four departments will be randomly assigned to either the managers being provided with the intervention (intervention group) or not (control group).

E-Learning: An already developed e-learning programme for managers to be completed online by managers in separate modules over 12 weeks. These modules aim to help managers understand and learn how to support and value their employees, increase employees control over their work where possible, ensure their employees are justly treated and identify and eliminate bullying. The e-learning programme will be introduced by a trained facilitator.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Adherence to e-learning intervention; Timepoints: Post e-learning intervention phase.

Secondary outcome measures

1. Managers' knowledge gained from the programme; timepoints: post e-learning intervention phase
2. Pre-post changes in employee sickness absence; timepoints: before and after the e-learning intervention
3. Pre-post changes in levels of employee wellbeing; timepoints: before and after the e-learning intervention
4. Psychosocial distress as measured by the General Health Questionnaire.; timepoints: before and after the e-learning intervention
5. Self-report psychosocial work characteristics; timepoints: before and after the e-learning intervention
6. Self-reported sickness absence; timepoints: before and after the e-learning intervention

Added 02/12/2013:
7. Acceptability of the intervention to managers; timepoints: after the e-learning intervention
8. Acceptability of the trial to managers and employees; timepoints: after the e-learning intervention
9. Feasibility of the trial; timepoints: before, during and after the intervention
10. Participation for managers; timepoints: before, during and after the intervention
11. Participation for employees; timepoints: after the intervention

Overall trial start date

01/06/2013

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

On an individual level:
1. Informed consent
2. Male and female, age at least 16 years

On an organisational level:
1. Providing internet access at work to employees
2. Organisational data on sickness absence available

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 440

Participant exclusion criteria

Current exclusion criteria as of 02/12/2013:
We will exclude from data collection employees for whom the intervention is unlikely to have an effect because they will not remain in the organisation for the duration of the study:
1. Long-term sick
2. Notified pregnancies
3. Employees on contracts due to expire or terminate during the course of the trial

Previous exclusion criteria:
We will exclude from data collection employees for whom the intervention is unlikely to have an effect because they will not remain in the organisation for the duration of the study:
1. Long-term sick
2. Notified pregnancies
3. Employees on fixed-term contracts due to expire during the course of the trial

Recruitment start date

01/06/2013

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London Queen Mary's School of Medicine and Dentistry
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary, University of London (UK)

Sponsor details

R&D Office
Barts & London School of Medicine
The QMI building
5 Walden Street
London
E1 2EF
United Kingdom
-
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Public Health Research; Grant Codes: 10/3007/06

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26269873
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26503383
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27507134

Publication citations

Additional files

Editorial Notes

11/08/2016: Publication reference added.