Supporting people with long-term health conditions and disabilities at work: a feasibility study of the Co-Manage self-management support programme
| ISRCTN | ISRCTN17076421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17076421 |
| Integrated Research Application System (IRAS) | 368966 |
| National Institute for Health and Care Research (NIHR) | 174567 |
| Sponsor | Loughborough University |
| Funder | National Institute for Health and Care Research |
- Submission date
- 26/01/2026
- Registration date
- 03/02/2026
- Last edited
- 03/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Many people in the UK live and work with a long-term health condition or disability, such as arthritis, mental health conditions, or neurological conditions. While many people want to remain in employment, managing a long-term condition alongside work can be difficult. Challenges may include fatigue, pain, stress, uncertainty about how to ask for support, or a lack of suitable workplace adjustments. These difficulties can lead to increased sickness absence, reduced wellbeing, or people leaving work altogether.
Supporting people to manage their health at work, often referred to as self-management, is a key priority for the NHS and the UK Government. Research shows that when workers are supported to manage their health, they are more likely to stay in work and maintain good wellbeing. However, in the UK there is currently no clear, evidence-based workplace programme that helps employees, managers and employers work together to support self-management.
The Co-Manage programme has been developed to address this gap. It is an online toolkit designed to support workers with any long-term health condition or disability, help managers provide appropriate support, and assist employers in creating supportive workplace policies and practices. This study aims to test whether a larger trial of Co-Manage would be feasible. The study will assess whether organisations and staff are willing to take part, whether the intervention can be delivered as planned, and whether it shows potential to improve health and reduce sickness absence.
Who can participate?
The study will involve organisations based in the UK from any sector, including public, private and voluntary organisations, provided they have at least ten employees. Participants will include workers aged 18 years or over who have a long-term health condition or disability that has lasted for at least 12 months. Managers and employer representatives, such as human resources or occupational health staff, will also be invited to take part. Participants must be able to use the internet and understand English well enough to complete online questionnaires. People can take part whether or not they have told their employer about their health condition.
What does the study involve?
This is a feasibility study, which means it is designed to test whether a larger study can be carried out in the future. Around eight organisations will take part. Each organisation will be randomly assigned either to receive access to the Co-Manage programme or to continue with their usual workplace support.
The Co-Manage intervention is an online toolkit with different resources for workers, managers and employers. Workers receive guidance on managing their health at work, communicating their needs and problem-solving. Managers receive guidance on how to support staff, hold supportive conversations and make reasonable adjustments. Employers receive information on good practice, workplace policies and how to support staff wellbeing. The materials are accessed online and can also be downloaded in paper form.
Participants will be asked to complete short online questionnaires at the start of the study and again after three and six months. Some participants may be invited to take part in an interview about their experiences. With consent, information about workers' sickness absence may also be collected from employer records 12 months before and up to 12 months after first using Co-Manage. Use of the Co-Manage website will be monitored to understand how the resources are used.
What are the possible benefits and risks of participating?
Taking part may help participants better understand how to manage health at work, improve communication between workers and managers, and increase confidence in dealing with health-related issues. The study may also help improve workplace support for others in the future. However, participants may not experience direct personal benefit.
The study is considered low risk. Some people may find it uncomfortable to reflect on health or work-related challenges. Participation is voluntary, and participants can withdraw at any time without giving a reason. Information about support services will be provided if taking part causes any distress.
Where is the study run from?
The study is led by Loughborough University in collaboration with researchers from the University of Nottingham, the University of Lincoln and Affinity Health at Work. The research will take place in workplaces across the UK.
When is the study starting and how long is it expected to run for?
The study is planned to start in March 2026 and will run until February 2028.
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) through the Public Health Research (PHR) Programme, reference number: NIHR174567.
Who is the main contact?
Dr David Maidment, Chief Investigator
D.W.Maidment@lboro.ac.uk
Contact information
Public, Scientific, Principal investigator
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
LE11 3TU
United Kingdom
 ORCID ID |
0000-0002-8416-519X |
|---|---|
| Phone | +44 (0)1509 225439 |
| d.w.maidment@lboro.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled feasibility trial. |
| Secondary study design | Cluster randomised trial |
| Scientific title | Empowering workplace self-management for individuals with long-term health conditions and health-related disabilities: a randomised controlled feasibility trial of the 'Co-Manage' intervention compared with usual workplace support |
| Study acronym | Co-Manage |
| Study objectives | The aim of this study is to assess whether a cluster randomised controlled trial of Co-Manage, a digital toolkit designed to support workplace self-management for individuals with any long-term condition or disability, can be done. Specific objectives are to assess/conduct: 1. Willingness/readiness of organisations and their workers to adopt and implement Co- Manage. 2. Willingness of organisations to take part in a 20-month study and be randomised. 3. Willingness of participants (workers with LTCs/disabilities, managers) to take part and retention through follow-up (6 months) with intervention uptake and completion as primary endpoints. 4. Potential for selection bias in control and intervention organisations as measured using participant characteristics at baseline. 5. Implementation of intervention adherence, delivery, and fidelity. 6. Changes in the primary outcome (number of sick/disability leave days) and secondary outcomes (e.g., work-based attendance, wellbeing, self-management) to inform a larger trial and estimate the inter-cluster (or intraclass) correlations (ICC) for these outcomes. 7. Pilot process evaluation to monitor how Co-Manage is perceived by participants from different demographic groups (e.g., age, gender, ethnicity, job role/type) and test a full process evaluation methodology in advance of a full trial. 8. Feasibility of collecting data on parameters needed for health economic evaluation in a subsequent larger trial. |
| Ethics approval(s) |
Submitted 26/01/2026, Loughborough University Ethics Review Human Participants Sub-Committee (Epinal Way, Loughborough, LE11 3TU, United Kingdom; +44 (0) 1509 222423; J.A.Green@lboro.ac.uk), ref: LEON 24912 |
| Health condition(s) or problem(s) studied | Any long-term condition or disability requiring ongoing management for ≥12 months. |
| Intervention | Study design and randomisation This is a two-arm cluster randomised controlled feasibility trial, with the organisation as the unit of randomisation. At least eight UK organisations will be recruited and randomised in a 1:1 ratio to either the Co-Manage intervention or usual practice control. Randomisation will be conducted by an independent statistician and, where possible, stratified by organisational size and type. Intervention arm: Co-Manage Organisations allocated to the intervention arm will receive Co-Manage, a digital, multi-component workplace self-management intervention designed to support workers with long-term health conditions or disabilities. Resources are accessed via a dedicated website and can be downloaded in paper form for offline use. Co-Manage targets multiple workplace levels simultaneously and provides tailored online resources for: • Workers with long-term health conditions/disabilities: self-led toolkits focusing on problem-solving, symptom management at work, communication with managers, requesting adjustments, goal setting, and building support networks. • Managers: e-resources, interactive case studies, and practical tools to support conversations about health at work, provide appropriate adjustments, and address barriers to self-management. • Employer stakeholders (e.g. Human Resources staff, senior leaders, Occupational Health professionals): educational materials outlining evidence-based practices for supporting workplace self-management, reviewing policies and procedures, and fostering a supportive organisational culture. Follow-up. Outcome measures will be collected at baseline, as well as 3- and 6-months. Organisational sickness/disability absence data will be collected retrospectively for the 12 months prior to baseline and prospectively during follow-up, where participant consent is provided. Intervention fidelity and dose. Engagement and fidelity will be assessed using website analytics (e.g. logins, time spent on resources, number and type of tools accessed or completed), supplemented by qualitative interviews. All users must complete introductory content to ensure a minimum level of exposure for the feasibility study. A composite measure of intervention “dose” will be explored to inform the definition of sufficient exposure for a future definitive trial. Control arm: Usual workplace practice Organisations allocated to the control arm will continue with usual workplace policies and practices for supporting workers with long-term health conditions or disabilities. As there is no standardised UK approach to workplace self-management support, usual practice may include existing policies, occupational health referrals, reasonable adjustments under the UK Equality Act 2010, employee assistance programmes, or sickness absence management procedures. At organisational onboarding, employer stakeholders will complete a standardised audit to document existing policies and support mechanisms. Use of these practices will also be assessed via participant self-report surveys and qualitative interviews during follow-up. Follow-up. The control period mirrors the intervention arm, with data collection at baseline, 3- and 6-months. Control participants will complete the same outcome measures as intervention participants. At the end of the feasibility study, organisations and participants in the control arm will be offered free access to the Co-Manage intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The number of sick/disability leave days (total days and discrete absence spells). Data will be collected at baseline from organisational records* for workers only in a 12-month period prior to intervention start and up to 12-months from study consent. |
| Key secondary outcome measure(s) |
Feasibility-related outcomes: |
| Completion date | 31/10/2027 |
Eligibility
| Participant type(s) | Employee, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. For employers, organisations from any sector with ≥10 employees with no existing processes or policies that conflict with Co-Manage (e.g., an alternative self-management support programme). 2. Any individual worker aged ≥18 years with any long-term condition or disability requiring ongoing management for ≥12 months. To enable assessment of the primary outcome, participants must have been employed for at least 12 months prior to the start of the intervention. 3. Managers supporting workers with any LTC or disability. 4. All participants must be able access to the internet and be able to understand English sufficiently to provide informed consent, complete online questionnaires, and use Co-Manage. |
| Key exclusion criteria | 1. Organisations with <2% of workers that have taken sick/disability leave (primary outcome) in the past 12 months, making it difficult to demonstrate potential impact of Co-Manage. 2. Worker participants who are <18 years of age, do not have a long-term condition/disability requiring ongoing management for ≥12 months, have been in their current employment for <12 months prior to the start of the intervention, and/or are unable to provide informed consent or participate in study procedures (e.g., due to cognitive or language barriers that cannot be reasonably accommodated). |
| Date of first enrolment | 01/03/2026 |
| Date of final enrolment | 31/10/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Loughborough
LE11 3TU
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | De-identified individual participant data (IPD) collected during the study will be available to other researchers following completion of the study. Data will be anonymised prior to sharing and will not contain any information that could identify individual participants or participating organisations. The anonymised dataset will be stored in Loughborough University’s secure research repository (https://repository.lboro.ac.uk/). |
Editorial Notes
03/02/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
