Coronary Heart Disease, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALSelf-Management Intervention
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
BEHAVIORALRisk Result
Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
Sponsors
University College, London
City, University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed