Type 2 diabetes in people with severe mental illness Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
This study will explore the feasibility of the DIAMONDS intervention, a supported diabetes self-management intervention for people with severe mental illness.
The intervention includes 16 weekly sess
Sponsors
University of York
Bradford District Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years or older) 2. Severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder) 3. Type 2 diabetes (insulin and non-insulin treated) The diagnosis of SMI will need to have been made by specialist psychiatric services or general practitioner (GP) and be documented in the patient’s medical records in general practice or secondary care. The diagnosis of diabetes needs to be of at least three months duration and documented in the medical record. Self-reported diabetes will be confirmed by primary care medical records
Exclusion criteria
Exclusion criteria: 1. Cognitive impairments 2. Gestational diabetes 3. Type 1 diabetes 4. Diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions 5. Lack of capacity to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/11/2021: 1. Recruitment rate, measured as the proportion of the recruitment target (n = 30) achieved at 5 months from the start of recruitment 2. Attrition measured as the proportion of missing outcomes data at the end of the recruitment period (5 months from the 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) Previous primary outcome measures: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 5 months 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 4 months 3. Intervention delivery rate recorded as the number of intervention sessions delivered to participants completing the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of data collection. Collected at baseline only (unless otherwise indicated): 1. HbA1c - blood test (results recorded as mmol/mol and %) 2. Cholesterol - biochemical lipid profile (blood test including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides all recorded as mmol/L) 3. Haemoglobin - blood test (results recorded in g/L) 4. Body Mass Index (BMI) (kg/m²) 5. Waist circumference (cm) 6. Blood pressure (mmHg) 7. Smoking status (self report - yes/no/never) 8. Urinary albumin to creatinine ratio (from medical records) 9. Physical activity (International Physical Activity Questionnaire [IPAQ] and wrist-worn accelerometers worn for seven days) 10. Comorbidities (from medical records) 11. Blood glucose level (measured through continuous glucose monitoring for 14 days) 12. Psychological health (psychiatric symptoms: Brief Psychiatric Rating Scale [BPRS]; depressive symptom severity: Patient Health Questionnaire-0 [PHQ-9]) 13. Diabetes measures (diabetes distress: Problem Areas In Diabetes [PAID] scale; summary of diabetes self-care activities: Summary of Diabetes Self-Care Activities [SDSCA] measure; insulin use (self report - yes/no); diabetes complications (from medical records) 14. Health related quality of life (EQ-5D-5L) 15. Health economic outcomes (health resource use: from medical records) 16. Mechanisms of Action (MoA: questionnaires at baseline and intervention end [16 weeks]) | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Brown
Outcome results
None listed