IGLOo: Sickness absence and sustainable return to work pilot study
| ISRCTN | ISRCTN11788559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11788559 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 313499 |
| Protocol serial number | CPMS 53316, IRAS 313499 |
| Sponsor | Rotherham Doncaster and South Humber NHS Foundation Trust |
| Funder | National Institute for Health and Care Research Central Commissioning Facility (CCF); Grant Codes: NIHR202986 |
- Submission date
- 09/09/2022
- Registration date
- 06/10/2022
- Last edited
- 20/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
The purpose of this return-to-work pilot study is to provide employees on long-term sick leave with an employee education pack of materials aimed at helping improve wellbeing whilst on long-term sick leave and improve their likelihood of remaining in work when they return.
Many people go on long-term sick leave for lots of different reasons including back pain, poor mental health and conditions that might need treatment or recovery time. Sometimes, those on long-term sick leave might experience poor mental well-being even if that is not the reason for their sick leave. Research shows that poor mental well-being is linked to longer lengths of sickness absence. However, a number of studies show that employees who experience good quality communication and contact with their workplace can feel positive about their work, and are more likely to feel ready to return to work and also return to work earlier than they expected. They are also more likely to have a more positive work experience once they are back at work.
Our return-to-work pilot study, called IGLOo (Individual, Group, Leaders, Organisation), provides employees who are on sick leave with an online toolkit they can access through a website. The online toolkit provides new guidance and step-by-step support from initial sick leave through to returning to work for the employee and remaining in work into the future. The employee’s manager, workplace return-to-work contact or employer will be asked to use a similar online toolkit that provides them with step-by-step guidance on how to support the employee whilst on sick leave and when returning to work. The leaders of the organisation will also have access to online webinars while colleagues will have the option of receiving information on how they can help so the means of support is complete.
Who can participate?
1. Organisations interested in supporting their employees during sick leave and upon their return to work
2. Employees who are on long-term sick leave in the participating organisations
3. Line managers who are managing an employee on long-term sick leave in the participating organisations
What does the study involve?
Taking part will provide employees on long-term sickness absence and line managers with mirrored toolkits designed to promote compassion and empathy towards the employee during their absence, to encourage early and positive workplace communication that supports an employee’s wellbeing whilst on sick leave and when returning to work and to offer checklists of actions to perform during their absence to ensure nothing is missed and a smooth return to work is set up. Additional emphasis is placed on making work adjustments to meet the employee’s needs once they return to work. Additional toolkits and webinars are designed for leaders within the organisations and colleagues of the employees on long-term sick with a view to shifting the organisation’s culture around long-term sickness absence from one of the negative assumptions and pressure to return to work as quickly as possible, to one of support, care and accommodation. Eight large organisations will be recruited where four will receive our programme and four will act as a comparison group, carrying on as normal. We will measure how many days employees stay at work without taking long-term sick leave again or leaving work within six months of returning. We will also ask participants to complete questions about their mental health and work, these will be asked before the programme and at 3, 6, 9 and 12 months. Organisations in the intervention group will receive a report on the study outcomes and may continue using the intervention resources. Organisations in the control group will receive a personalised report on their return-to-work processes
What are the possible benefits and risks of participating in the study?
Employee participants receiving the intervention may experience health benefits and feel better supported by their line manager. A potential risk is that the employee may feel coerced into participating by their employer (who will send the employee the study information after the employer has identified them as being on long-term sick leave). However, every effort will be made to reduce this risk by informing the organisation of the study protocol, promoting the study before the trial starts and by the research team checking with each employee that their participation is entirely voluntary before consenting them.
Where is the study run from?
University of Loughborough (UK)
When is the study run from and how long is it expected to run for?
March 2022 to February 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main study contact?
Professor Fehmidah Munir
f.munir@lboro.ac.uk
Contact information
Scientific
Rotherham, Doncaster and South Humber NHS Foundation Trust
Bungalow 2
St Catherine’s Close
Tickhill Road
Doncaster
DN4 8QN
United Kingdom
| Phone | +44 (0)7970049942 |
|---|---|
| j.mckie@nhs.net |
Principal investigator
School of Sport
Exercise and Health Sciences
University of Loughborough
Clyde Williams Building
Epinal Way
Loughborough
LE11 3TU
United Kingdom
 ORCID ID |
0000-0002-5585-0243 |
|---|---|
| Phone | +44 (0)1509 228228 |
| f.munir@lboro.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot cluster randomized case-controlled study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 42352 IGLOo PIS Control Line Manager Group v6.1 20.09.22.pdf |
| Scientific title | Sustainable return to work: A pilot cluster randomised controlled trial of a multicomponent workplace ‘IGLOo’ intervention compared with usual return-to-work support |
| Study acronym | IGLOo |
| Study objectives | As a pilot trial primarily concerned with feasibility, acceptability and preliminary data collection, this study is not designed or statistically powered to test a specific hypothesis. The IGLOo intervention reduces the number of days of long-term sickness when compared with business-as-usual control. |
| Ethics approval(s) | Approved 05/08/2022, East Midlands – Leicester Central Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8066, +44 (0)207 104 8199; leicestercentral.rec@hra.nhs.uk), ref: 22/EM/0143 |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | Feasibility outcome: quantitative data describing recruitment (types of organisations participating, number of employees on long-term sick leave eligible to take part, number of employees who consent to take part, number of line managers who consent to take part), intervention (e.g. number of participants completing the steps in the online toolkits, number of times each section of the toolkit is used and attrition, number of health coaching sessions received, online training viewed and completed) gathered using study logs and predesigned forms. The forms to capture the specific data will be unique to this study and developed for its purpose. |
| Intervention type | Other |
| Primary outcome measure(s) |
The number of days taken until the first day of return to work (partial or full return) using organisational records and self-report. Data collected monthly (organisational records) and at 3 6, 9 and 12 months (self-reported) |
| Key secondary outcome measure(s) |
1. Work demands, measured by the HSE Job Demands Questionnaire, completed at baseline and 12 months |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 7063 |
| Total final enrolment | 7068 |
| Key inclusion criteria | Current participant inclusion criteria as of 09/05/2023: 1. Individuals aged 18 years and over, on long-term sick leave (defined as > 14 days) due to occupational burnout and/or a common mental health problem as a primary reason or where is it known as associated comorbidity. 2. Line managers of participants on long-term sick leave. 3. Consistent with national clinical guidelines, common mental health problems meeting eligibility criteria for this study include: adjustment disorders (including reactive stress), major depressive disorder, generalised anxiety disorder, mixed anxiety and depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobias, social anxiety disorder, panic disorder with/without agoraphobia, health anxiety, functional disorders and anxiety-related somatic symptoms 4. The study will also include participants whose sickness absence is related to other chronic illnesses which are known to be highly comorbid with common mental disorders listed above; such as coronary heart disease, diabetes, musculoskeletal problems, chronic obstructive pulmonary disease, and other long-term conditions (LTC). This inclusion criterion is necessary to properly identify participants who are affected by common mental disorders, but whose primary reason for sickness absence may be a LTC recorded in their occupational records. We acknowledge that some employees may prefer to report a LTC as a primary reason for sickness, rather than a mental health problem, considering that the latter may be perceived as stigmatising. Previous participant inclusion criteria: Large organisations with 600 employees and above. This will include NHS trusts, public and private sector employers in Yorkshire and in particular, the South Yorkshire and South Humber region. 1. Public and private sector organisations 2. Line managers of participants on long-term sick leave 3. Individuals aged 18 years and over on long-term sick leave (defined as > 14 days) due to occupational burnout and/or a common mental health problem as a primary reason or where is it known as associated comorbidity 4. Consistent with national clinical guidelines, common mental health problems meeting eligibility criteria for this study include: adjustment disorders (including reactive stress), major depressive disorder, generalised anxiety disorder, mixed anxiety and depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobias, social anxiety disorder, panic disorder with/without agoraphobia, health anxiety, functional disorders and anxiety-related somatic symptoms 5. The study will also include participants whose sickness absence is related to other chronic illnesses which are known to be highly comorbid with common mental disorders listed above; such as coronary heart disease, diabetes, musculoskeletal problems, chronic obstructive pulmonary disease, and other long-term conditions (LTC). This inclusion criterion is necessary to properly identify participants who are affected by common mental disorders, but whose primary reason for sickness absence may be a LTC recorded in their occupational records. We acknowledge that some employees may prefer to report a LTC as a primary reason for sickness, rather than a mental health problem, considering that the latter may be perceived as stigmatising. |
| Key exclusion criteria | 1. Organisations that outsource their return-to-work management. 2. Organisations that have <2% of workers taking long-term sick in the past 12 months. 3. Individuals on long-term sick leave due to a severe mental disorder (psychotic disorder; bipolar disorder); substance use disorder; a neurological condition such as dementia; or under investigation for misconduct or formal disciplinary action 4. Workers aged 17 years of age and under |
| Date of first enrolment | 15/11/2022 |
| Date of final enrolment | 15/09/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Tickhill Road
Doncaster
DN4 8QN
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
2 Brindley Way
Wakefield 41 Industrial Estate
Wakefield
WF2 0XQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to this being a feasibility study. If the data collected are sufficient to share the researchers will reconsider. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/02/2024 | 05/02/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 6.1 | 20/09/2022 | 28/09/2022 | No | Yes |
| Participant information sheet | version 6.1 | 20/09/2022 | 28/09/2022 | No | Yes |
| Participant information sheet | version 6.1 | 20/09/2022 | 28/09/2022 | No | Yes |
| Participant information sheet | version 6.1 | 20/09/2022 | 28/09/2022 | No | Yes |
| Participant information sheet | version 5.1 | 20/09/2022 | 28/09/2022 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 5.2 | 11/07/2022 | 28/09/2022 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 42352 IGLOo Trial Protocol v5.2 11.07.22.pdf
- Protocol file
- 42352 IGLOo PIS Control Line Manager Group v6.1 20.09.22.pdf
- Participant information sheet
- 42352 IGLOo PIS Intervention Line Manager Group v6.1 20.09.22.pdf
- Participant information sheet
- 42352 IGLOo PIS Control Employee Group v6.1 20.09.22.pdf
- Participant information sheet
- 42352 IGLOo PIS Intervention Employee Group v6.1 20.09.22.pdf
- Participant information sheet
- 42352 IGLOo PIS Intervention Phase 1 Management Group v5.1 20.09.22.pdf
- Participant information sheet
Editorial Notes
20/02/2025: The target number of participants was changed 5750 to 7063. Total final enrolment added.
25/07/2024: The recruitment end date was changed from 30/06/2024 to 15/09/2024.
05/02/2024: Publication reference added.
30/01/2024: The recruitment end date was changed from 31/01/2024 to 30/06/2024.
17/10/2023: The following changes have been made:
1. The recruitment end date was changed from 01/10/2023 to 31/01/2024.
2. The target number of participants was changed from 100 to 5750.
3. Sheffield Teaching Hospitals NHS Foundation Trust, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, and Yorkshire Ambulance Service NHS Trust were added to the study participating centres.
4. IPD sharing statement added.
09/05/2023: The following changes have been made:
1. The participant inclusion criteria have been changed.
2. The recruitment start date has been changed from 01/09/2022 to 15/11/2022.
3. The Participant inclusion criteria: Age group was changed from Adult to MIxed.
26/04/2023: The recruitment end date has been changed from 01/10/2022 to 01/10/2023.
09/09/2022: Trial's existence confirmed by the NIHR.
