A Randomised Control Trial (RCT) to Investigate the Effectiveness of a Selfmanagement Intervention and Personalised Genetic Risk Information to Reduce Risk of Coronary Heart Disease in Patients With Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 10
- 主要终点
- Coronary heart disease 10 year risk
研究概览
简要总结
The primary objective of the CORDIA study is to use an effective evidence-based self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give a personalised genetic and lifestyle risk of coronary heart disease, to examine their capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management in primary care patients with type 2 diabetes. The effect of these interventions on clinical, behavioural and psychological outcomes will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 25-70 years diagnosed with type 2 diabetes
- •White, Afro-Caribbean or Asian-Indian ethnicity
- •Most previous or baseline HbA1c ≥6.5% or 48 mmol/mol
- •Fluency in written and spoken English
排除标准
- •Diagnosis of ischemic heart disease, stroke, Transient Ischaemic Attack (TIA) or peripheral vascular disease
- •Serious or enduring mental health problems that would prevent the patient from completing the study
- •Currently receiving treatment for a life-threatening condition (e.g., cancer) or in the terminal stages of a condition
- •Adults who cannot consent for themselves
研究组 & 干预措施
Usual Care
The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.
Group Self-Management Intervention (SMI)
Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.
干预措施: Self-Management Intervention (Behavioral)
SMI + Risk Results
The participant will provide a saliva sample for analysis. They will attend an appointment with their nurse to receive personalised results on their combined genetic and lifestyle risk for developing CHD in the next 10 years. They will then be asked to attend the 4 week SMI programme.
干预措施: Self-Management Intervention (Behavioral)
SMI + Risk Results
The participant will provide a saliva sample for analysis. They will attend an appointment with their nurse to receive personalised results on their combined genetic and lifestyle risk for developing CHD in the next 10 years. They will then be asked to attend the 4 week SMI programme.
干预措施: Risk Result (Behavioral)
结局指标
主要结局
Coronary heart disease 10 year risk
时间窗: 12 months
Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
次要结局
- Psycho-social impact of the intervention(12 months)
- Health behaviour impact of the intervention(12 months)
- Impact of receiving genetic results(6 months)
研究者
Stanton Newman
Professor
City, University of London