Coronary Heart Disease Risk in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Coronary Heart Disease; Type 2 Diabetes

• Registration Number: NCT01891786
• Lead Sponsor: City, University of London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-28
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

Addison House Surgery; 🇬🇧 Harlow, Essex, United Kingdom

Church Street Surgery; 🇬🇧 Ware, Essex, United Kingdom

Dolphin House Surgery; 🇬🇧 Ware, Essex, United Kingdom

Wallace House Surgery; 🇬🇧 Hertford, Hertfordshire, United Kingdom

Cambridgeshire Community Services NHS Trust; 🇬🇧 Cambridgeshire, United Kingdom

Chesterfield Drive Surgery; 🇬🇧 Ipswich, United Kingdom

Martlesham health Surgery; 🇬🇧 Ipswich, United Kingdom

Dr Taylor and Partners; 🇬🇧 Woodbridge Suffolk, United Kingdom

The Peninsula Practice; 🇬🇧 Woodbridge Suffolk, United Kingdom

Wickham Market Medical Centre; 🇬🇧 Woodbridge Suffolk, United Kingdom