Coronary Heart Disease Risk in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Coronary Heart Disease, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Self-Management Intervention
* Behavioral: Risk Result


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient. | |
| Active Comparator: Group Self-Management Intervention (SMI)<br>Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis. | Behavioral: Self-Management Intervention<br>* The SMI will incorporate a discussion to introduce self-management and why it is important, and about problems associated with reducing CHD risk and managing type 2 diabetes. Specific topics addressed will include health behaviours to reduce CHD risk and manage diabetes including diet and exercise, as well as behaviours specific to managing diabetes, including medication adherence and self-care behaviours (e.g. footcare). Sessions are patient-directed and employ a shared decision-making approach, such that participants work with one another and the practice nurse facilitator to identify specific problems that they wish to address, and to identify solutions and approaches to managing their diabetes and CHD risk<br>|
| Active Comparator: SMI + Risk Results<br>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. | Behavioral: Self-Management Intervention<br>* The SMI will incorporate a discussion to introduce self-management and why it is important, and about problems associated with reducing CHD risk and managing type 2 diabetes. Specific topics addressed will include health behaviours to reduce CHD risk and manage diabetes including diet and exercise, as well as behaviours specific to managing diabetes, including medication adherence and self-care behaviours (e.g. footcare). Sessions are patient-directed and employ a shared decision-making approach, such that participants work with one another and the practice nurse facilitator to identify specific problems that they wish to address, and to identify solutions and approaches to managing their diabetes and CHD risk<br>Behavioral: Risk Result<br>* Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary heart disease 10 year risk | Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psycho-social impact of the intervention | 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. | 12 months | 
| Health behaviour impact of the intervention | 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. | 12 months | 
| Impact of receiving genetic results | The impact of receiving genetic test results using a modified version of the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. | 6 months |