NCT01891786

Coronary Heart Disease Risk in Type 2 Diabetes

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: City, University of London · Academic / Other
• Sex: All
• Age: 25 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease
• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Self-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
BEHAVIORAL	Risk Result	Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-07-03
• Last updated: 2016-08-04

Locations

10 sites across 1 country: United Kingdom