DIAMONDS Feasibility Study v1.0
Research type
Research Study
Full title
DIAMONDS - Improving diabetes self-management for people with severe mental illness
IRAS ID
279019
Contact name
Najma Siddiqi
Contact email
Sponsor organisation
University of York
ISRCTN Number
ISRCTN15328700
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
People with severe mental illness (SMI) have poorer physical health and a shorter life expectancy by around 20 years compared with the general population. This so-called mortality gap is partly explained by higher rates and poorer management of physical long-term conditions (LTCs) such as diabetes. There may be several reasons for this, including the individual’s mental illness and treatment, challenges to engaging in healthy behaviours, and wider barriers to accessing healthcare and support.
Self-management (eg, taking medications, monitoring symptoms, preventing complications, leading a healthier lifestyle) is an important part of staying well with an LTC. Self-management programmes in the NHS help people with LTCs look after themselves but they often do not address the challenges faced when also managing SMI.
The DIAMONDS research programme aims to overcome this problem by developing a self-management intervention to specifically help people with diabetes and SMI to be healthier. The intervention has been developed in partnership with people with mental illness and diabetes, their family members/friends, and healthcare staff. 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 ability to engage in self-management; limited knowledge and skills for LTC management; and beliefs that LTCs require less managing than mental illness. The DIAMONDS intervention is a 16-week programme that consists of daily self-management tasks, weekly 1-to-1 meetings with a trained facilitator (‘DIAMONDS Coach’) and monthly peer-support group sessions.
In this study (phase 3 of the DIAMONDS programme) we will test whether we can deliver our intervention and explore whether it is acceptable to those people delivering and receiving it. We will also test out our research methods so that we can design a larger study in the future to test whether our intervention works.
Summary of Results:
The aim of this feasibility study was to test the acceptability and feasibility of research processes and intervention delivery in preparation for a randomised controlled trial (RCT).
We successfully recruited 30 participants (adults with serious mental illness and type 2 diabetes) from six NHS mental health trusts in the North of England. Recruitment, consent, and data collection processes were confirmed to be feasible and acceptable to both participants and researchers. Data collection included physical measures (height, weight, waist circumference), blood taking (for measurement of glycated haemoglobin, HbA1c at a central laboratory), questionnaires, as well as measurement of physical activity using a wrist-worn accelerometer (activity tracker) and monitoring of sugar levels using continuous glucose monitors.
The DIAMONDS intervention was well received by participants and intervention facilitators (DIAMONDS Coaches). In qualitative interviews we found out that flexibility and participant-centred intervention content were particularly important. We developed methods to assess intervention fidelity (i.e. the extent to which the intervention is delivered as intended) which we will be able to use in the RCT. We also put in place processes to measure health resource use which will be used in the RCT to inform evaluation of cost-effectiveness.
All prespecified objectives and progression criteria were met and the DIAMONDS project will progress to the next stage (RCT). Findings from this feasibility study will directly inform refinements to the intervention and study processes for the RCT.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0059
Date of REC Opinion
24 Mar 2021
REC opinion
Favourable Opinion