Improving Diabetes Outcomes for People With Severe Mental Illness (SMI): a Longitudinal Observational and Qualitative Study of Patients in England
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46,564
- 试验地点
- 1
- 主要终点
- Diabetic control
研究概览
简要总结
This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further.
The study utilises a mixed methods design comprising analysis of patient primary care records and interviews with patients living with comorbid SMI and diabetes, family carers and healthcare professionals involved in commissioning or delivering healthcare for this population. This entry on the Protocol Registration and Results System describes only the quantitative Work Package of the study in detail i.e. analysis of patient primary care records.
详细描述
People living with severe mental illness (SMI) have a lower life expectancy (by around 20 years) than the general population, often dying of preventable or manageable illnesses (Woodhead et al., 2014). Diabetes contributes significantly to this health inequality, being 2-3 times more likely in people with SMI (Stubbs et al., 2015). This study aims to understand the determinants of type 2 diabetes and variation in diabetes outcomes for people with SMI in order to identify potential healthcare interventions that can be tested further.
Research questions:
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What are the socio-demographic and illness-related risk factors associated with
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developing type 2 diabetes in people with SMI?
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variation in diabetes and mental health outcomes in people with SMI and type 2 diabetes?
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How do physical and mental health outcomes differ between people with SMI and type 2 diabetes,
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compared to people with SMI without diabetes?
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compared to people with type 2 diabetes but no SMI?
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What factors influence access to, and receipt of, diabetes care for people with SMI, and how are diabetes healthcare interventions experienced by people with SMI?
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How and at what cost is type 2 diabetes monitored and managed in people with SMI compared to those without SMI?
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What healthcare interventions (e.g. medication, referrals and care pathways) are associated with better diabetes outcomes for people with SMI and type 2 diabetes?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and over
- •Patients with diagnoses of severe mental illness, severe mental illness and type 2 diabetes, or with diabetes but no diagnosis of severe mental illness.
- •Patients with research-quality data.
排除标准
- •Patients under the age of 18
- •Patients without research quality data.
- •Patients who were diagnosed with Type 1 diabetes following a diagnosis of Type 2 diabetes.
- •Patients who have a code for a diabetic complication (e.g. diabetic retinopathy) but no diagnostic code for diabetes.
结局指标
主要结局
Diabetic control
时间窗: 01/04/2000-31/03/2016
Changes in HbA1c
Cardiovascular control: Blood pressure
时间窗: 01/04/2000-31/03/2016
Changes in blood pressure
Cardiovascular control: Lipid profile
时间窗: 01/04/2000-31/03/2016
Changes in serum cholesterol levels
Diabetic complications 1: Glucose dysregulation
时间窗: 01/04/2000-31/03/2016
Hyperglycaemic or hypoglycaemic events
Diabetic complications 2: Micro-vascular complications
时间窗: 01/04/2000-31/03/2016
Clinical diagnosis of micro-vascular complications e.g. peripheral neuropathy
Diabetes status
时间窗: 01/04/2000-31/03/2016
Clinical diagnosis of Type 2 diabetes
Diabetes onset
时间窗: 01/04/2000-31/03/2016
Time from diagnosis of SMI to diagnosis of type 2 diabetes
Diabetic complications 3: Macro-vascular complications
时间窗: 01/04/2000-31/03/2016
Clinical diagnosis of macro-vascular complications e.g. myocardial infarction
Mental Health Outcomes - Depression
时间窗: 01/04/2000-31/03/2016
Clinician diagnosis of depression
Mental Health Outcome - SMI relapse
时间窗: 01/04/2000-31/03/2016
Clinician diagnosis of SMI relapse
Mental Health Outcome - Anxiety
时间窗: 01/04/2000-31/03/2016
Clinical diagnosis of anxiety
Hospital admissions
时间窗: 01/04/2000-31/03/2016
Number and type of admissions related to diabetes, severe mental illness or diabetic complications
Mortality
时间窗: 01/04/2000-31/03/2016
Patient death
Healthcare costs
时间窗: 01/04/2000-31/03/2016
Cost of primary care consultations
Primary care consultations
时间窗: 01/04/2000-31/03/2016
The number and type of primary care consultations
Healthcare interventions - medication use
时间窗: 01/04/2000-31/03/2016
Prescription of antipsychotic medication, antidepressant medication, antihypertensive medication
Healthcare interventions - referrals
时间窗: 01/04/2000-31/03/2016
Referrals for self-management education, diabetes clinics
次要结局
未报告次要终点
研究者
Najma Siddiqi
Principal Investigator
University of York