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| ID | Type | Description | Link |
|---|---|---|---|
| RRMR11-001 | Other Grant/Funding Number | The Bupa Foundation |
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| Name | Class |
|---|---|
| University College, London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient. | |
| Group Self-Management Intervention (SMI) | Active Comparator | Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis. |
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| SMI + Risk Results | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Management Intervention | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanton P Newman, PhD | City, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addison House Surgery | Harlow | Essex | CM20 1DS | United Kingdom | ||
| Church Street Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716211 | Derived | Beaney KE, Ward CE, Bappa DA, McGale N, Davies AK, Hirani SP, Li K, Howard P, Vance DR, Crockard MA, Lamont JV, Newman S, Humphries SE. A 19-SNP coronary heart disease gene score profile in subjects with type 2 diabetes: the coronary heart disease risk in type 2 diabetes (CoRDia study) study baseline characteristics. Cardiovasc Diabetol. 2016 Oct 3;15(1):141. doi: 10.1186/s12933-016-0457-7. | |
| 26631181 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Risk Result | Behavioral | Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD. |
|
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 |
| Ware |
| Essex |
| SG12 9EG |
| United Kingdom |
| Dolphin House Surgery | Ware | Essex | SG12 9HJ | United Kingdom |
| Wallace House Surgery | Hertford | Hertfordshire | SG14 1HZ | United Kingdom |
| Cambridgeshire Community Services NHS Trust | Cambridgeshire | PE27 4LG | United Kingdom |
| Chesterfield Drive Surgery | Ipswich | IP1 6DW | United Kingdom |
| Martlesham health Surgery | Ipswich | IP5 3SL | United Kingdom |
| Dr Taylor and Partners | Woodbridge Suffolk | IP12 1EE | United Kingdom |
| The Peninsula Practice | Woodbridge Suffolk | IP12 2NN | United Kingdom |
| Wickham Market Medical Centre | Woodbridge Suffolk | IP13 0SB | United Kingdom |
| Derived |
| Davies AK, McGale N, Humphries SE, Hirani SP, Beaney KE, Bappa DA, McCabe JG, Newman SP. Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial. Trials. 2015 Dec 2;16:547. doi: 10.1186/s13063-015-1073-7. |
| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |