Coronary Heart Disease Risk in Type 2 Diabetes
- Conditions
- Coronary Heart DiseaseType 2 Diabetes
- Interventions
- Behavioral: Self-Management InterventionBehavioral: Risk Result
- Registration Number
- NCT01891786
- Lead Sponsor
- City, University of London
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Self-Management Intervention (SMI) Self-Management Intervention Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis. SMI + Risk Results Self-Management Intervention 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. SMI + Risk Results Risk Result 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.
- Primary Outcome Measures
Name Time Method Coronary heart disease 10 year risk 12 months Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
- Secondary Outcome Measures
Name Time Method Psycho-social impact of the intervention 12 months Psycho-social impact of the intervention conditions will be assessed using questionnaires designed to measure risk perception, self-efficacy, and motivation. Feelings of anxiety and depression will also be assessed.
Health behaviour impact of the intervention 12 months The impact of the intervention conditions on health behaviours including diet, exercise and smoking behaviour will be assessed in addition to a range of diabetes self-care behaviours such as foot care and blood glucose self-monitoring.
Impact of receiving genetic results 6 months The impact of receiving genetic test results using a modified version of the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire.
Trial Locations
- Locations (10)
Cambridgeshire Community Services NHS Trust
🇬🇧Cambridgeshire, United Kingdom
Chesterfield Drive Surgery
🇬🇧Ipswich, United Kingdom
Martlesham health Surgery
🇬🇧Ipswich, United Kingdom
The Peninsula Practice
🇬🇧Woodbridge Suffolk, United Kingdom
Dr Taylor and Partners
🇬🇧Woodbridge Suffolk, United Kingdom
Wickham Market Medical Centre
🇬🇧Woodbridge Suffolk, United Kingdom
Church Street Surgery
🇬🇧Ware, Essex, United Kingdom
Wallace House Surgery
🇬🇧Hertford, Hertfordshire, United Kingdom
Addison House Surgery
🇬🇧Harlow, Essex, United Kingdom
Dolphin House Surgery
🇬🇧Ware, Essex, United Kingdom