The DIAMONDS intervention to support self-management of type 2 diabetes in people with severe mental illness: Study protocol for a single-group feasibility study

Abstract

Introduction.The DIAMONDS programme aims to evaluate a novel supported diabetes self-management intervention for people with severe mental illness (the “DIAMONDS intervention”). The purpose of this study is to test the feasibility of intervention delivery and data collection procedures to inform a definitive randomised controlled trial (RCT).Methods.Adults aged 18 years or over with a diagnosis of type 2 diabetes and severe mental illness (schizophrenia, schizoaffective disorder, or bipolar disorder) will be eligible for inclusion. Individuals with other types of diabetes or non-psychotic mental illness and those lacking capacity to consent will not be eligible. Participants will be recruited from NHS mental health trusts and general practices across the North of England. All participants will receive the DIAMONDS intervention: weekly one-to-one sessions with a trained facilitator (“DIAMONDS Coach”) to support goal setting, action planning, and diabetes education; ongoing self-management supported by a paper-based workbook and optional digital application (app); and monthly peer-support group sessions with other participants. The primary outcomes are: 1. Recruitment rate, measured as proportion of the recruitment target (N ​= ​30) achieved at 5 months from start of recruitment, 2. Attrition measured as the proportion of missing outcomes data at the end of the recruitment period (5 months from start of recruitment) for physiological and self-reported data items, 3. Intervention delivery rate recorded as the proportion of planned sessions delivered (measured by the number of completed intervention session logs per participant within 15 weeks of the first intervention session). Secondary outcomes include completeness of data collection at baseline and of process evaluation data at follow-up as well as the feasibility and acceptability of the intervention and of wearing a blinded continuous glucose monitoring device. An intervention fidelity framework will also be developed. Recruitment started in July 2021. The study was prospectively registered: ISRCTN15328700 (12th March 2021).Discussion.The results of this feasibility study will inform the refinement of the content and delivery of the DIAMONDS intervention, as well as research procedures, including recruitment and data collection, in preparation for the main DIAMONDS RCT.