NCT01891786
Completed
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- City, University of London
- Enrollment
- 211
- Locations
- 10
- Primary Endpoint
- Coronary heart disease 10 year risk
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Stanton Newman
Professor
City, University of London
Eligibility Criteria
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
Outcomes
Primary Outcomes
Coronary heart disease 10 year risk
Time Frame: 12 months
Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
Secondary Outcomes
- Psycho-social impact of the intervention(12 months)
- Health behaviour impact of the intervention(12 months)
- Impact of receiving genetic results(6 months)
Study Sites (10)
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