An interventional study of Self-Management Intervention and Risk Result in Coronary Heart Disease and Type 2 Diabetes, sponsored by City, University of London. Completed at 10 sites in United Kingdom. Open to participants aged 25 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by City, University of London · Not applicable, Interventional, and Prevention
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.
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 211 is above the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →City, University of London is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.
Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.
Behavioral: 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.
Behavioral: Self-Management Intervention · Behavioral: Risk Result
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
Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
Coronary heart disease 10 year risk
Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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City, University of London