DIAMONDS Randomised Control Trial
Research type
Research Study
Full title
DIAMONDS - Improving diabetes self-management for people with severe mental illness
IRAS ID
316173
Contact name
Najma Siddiqi
Contact email
Sponsor organisation
University of York
ISRCTN Number
22275538
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
People with severe mental illness (SMI), such as schizophrenia or bipolar disorder, 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 (e.g. financial, social).
Self-management 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 an SMI.
The DIAMONDS research programme have developed a self-management intervention that can specifically help people with diabetes and an SMI to be healthier. It has been developed in partnership with people with mental illness and diabetes, their family members/friends, and the healthcare staff who support them. The DIAMONDS intervention is a 6-month programme that consists of daily self-management tasks (such as goal setting and action planning) and 1-to-1 meetings with a trained facilitator.
In this study, which is phase 4 of the DIAMONDS programme, we will compare two groups of participants to test whether our intervention works. One group will receive the DIAMONDS intervention, the other will not. It will be decided randomly which participant will be in which group. We will take blood samples at the beginning of the study and after 6 and 12 months to see if the intervention helps people look after their diabetes.Lay summary of study results:
We wanted to see if the DIAMONDS programme helped people get healthier by lowering their blood sugar levels. The DIAMONDS group had slightly lower blood sugar levels after 12 months. But the difference between the DIAMONDS programme group and the usual care group was small and that could have just happened by chance. Other studies have found that a similar-sized change is not linked to better diabetes health. We also looked at some other areas of mental and physical health including body mass index (BMI), how bad depression or psychiatric symptoms were and stress levels caused by having diabetes. We found there were no big differences at 6 months or 12 months between the two groups in any of these areas.
We also found that self-care of diabetes was about the same between groups. In the DIAMONDS group, most people attended their coaching sessions and said that they really enjoyed the one-to-one sessions with their DIAMONDS Coach. Staying on track was hard when life got difficult. Things like feeling unwell, having problems with housing or feeling lonely made it difficult to keep up with the programme. Sometimes health services didn't talk to each other very well, which made getting the right care hard. Some people had lots of help from their family, whereas others didn't have any.
Even though people used the support package, it did not lead to clear improvements in blood sugar, diabetes self-care or overall health. This suggests such support alone is not enough to overcome the complex challenges of managing diabetes alongside mental illness. The DIAMONDS programme proved that people with severe mental illness, who are often left out of research, can and will take part in research. By delivering one of the largest trials in this population, we helped NHS sites build skills to support this group to take part in future research. Healthcare staff gained Coaching skills, and the confidence to support people with mental illness, potentially boosting morale, job satisfaction and career progression.
In the future, we need to use a 'whole system' approach, which combines support for self-care with medication, and at the same time, links social care services. Newer medication that help with weight loss could also be paired with coaching which may help the health benefits last much longer for people with both type 2 diabetes and severe mental illness. By bringing all these different types of help together, we can make sure nobody has to manage their health alone. This 'whole system' approach will also be needed for other co-existing health conditions - like heart or lung disease. We have developed a flexible guide to help adapt the support package for these and other conditions. People with serious mental illness face big health challenges, and it is a huge problem that they often don't live as long as everyone else. We need to work towards closing that 'health gap' and make sure everyone gets the chance to live a long, full life.REC name
West of Scotland REC 3
REC reference
22/WS/0117
Date of REC Opinion
23 Aug 2022
REC opinion
Favourable Opinion