Improving diabetes self-management for people with severe mental illness

Plain English summary of protocol

Background and study aims
People with severe mental illness, such as schizophrenia, bipolar disorder, or severe depression, have poorer physical health and a shorter life expectancy by around 20 years compared with the general population. Higher rates and poorer management of physical long-term conditions such as diabetes and heart disease are partly to blame. There may be several reasons for this, including the individual’s mental illness and treatment, challenges to engaging in healthy behaviours (e.g. exercise, healthy eating), and barriers to accessing healthcare and support. Self-management (which includes taking medications, monitoring symptoms, preventing complications, and leading a healthier lifestyle) is an important part of staying well with a long-term condition. There are many self-management programmes in the NHS to help people with long-term conditions look after themselves, but they often do not address the challenges of people who also have a severe mental illness. The DIAMONDS research programme aims to overcome this problem by developing and testing a self-management intervention that can specifically help people with diabetes and severe mental illness to be healthier. The intervention has been developed in partnership with people with mental illness and diabetes, their family members/friends, and the healthcare staff who support them. It has been designed to address challenges to self-management, which include poor motivation due to mental illness symptoms and medication; limited support from others for self-management; beliefs about their ability to engage in self-management; and limited knowledge and skills for long-term condition management.

Who can participate?
Patients aged 18 years or older with a severe mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis, severe depression) and type 2 diabetes

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention group will be offered one-to-one self-management sessions with a DIAMONDS coach over a period of 6 months. The control group will continue with their routine care. All participants will be followed up 6 and 12 months later.

What are the possible benefits and risks of participating?
Participants in both groups may gain insight into their own lifestyle and behaviours. The participants in the intervention group may develop strategies to manage their diabetes more efficiently. For participants using the digit app, they may develop new skills by engaging with digital technology. Taking part in the study will require participants to attend appointments, have body measurements and blood taken, and complete a study questionnaire which will take time.

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
September 2022 to September 2025

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

Who is the main contact?
Dr Lucy Sheehan, lucy.sheehan@york.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Additional files

42543_PIS_V2.0_25Aug22.pdf

Participant information sheet

42543_PROTOCOL_V1.0_28Jun22.pdf

Protocol file

ISRCTN22275538_SAP_V1.0.pdf

Statistical Analysis Plan

Editorial Notes

10/01/2025: Statistical analysis plan uploaded.
25/10/2024: Participant inclusion and exclusion criteria were updated.
07/10/2024: The following changes were made:
1. The total final enrolment was added.
2. The following study participating centres were added: South West London & St Georges Mental Health NHS Trust, Gloucestershire Health and Social Care NHS Foundation Trust, Cornwall Partnership NHS Foundation Trust, Somerset NHS Foundation Trust, Devon Partnership NHS Trust, Herefordshire and Worcestershire Health and Care NHS Trust, Surrey and Borders Partnership NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust, Livewell Southwest, Lancashire and South Cumbria NHS Foundation Trust, Essex Partnership University NHS Foundation Trust, Rotherham Doncaster and South Humber NHS Foundation Trust, Cheshire and Wirral Partnership NHS Foundation Trust, Pennine Care NHS Foundation Trust, Birmingham and Solihull Mental Health NHS Foundation Trust, Midlands Partnership University NHS Foundation Trust, Camden and Islington NHS Foundation Trust, Barnet, Enfield and Haringey Mental Health NHS Trust, and the Kent and Medway NHS and Social Care Partnership Trust.
3. A study contact was changed.
23/07/2023: The recruitment start date was changed from 03/10/2022 to 20/12/2022.
05/04/2024: The following changes have been made:
1. The overall study end date was changed from 03/05/2025 to 30/09/2025.
2. The interventions were changed.
3. The target number of participants was changed from "Planned Sample Size: 450; UK Sample Size: 450" to "Planned Sample Size: 380; UK Sample Size: 380".
4. The recruitment end date was changed from 03/04/2024 to 30/09/2024.
05/10/2022: Trial's existence confirmed by the NIHR.