Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01891786
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : August 4, 2016
University College, London
Information provided by (Responsible Party):
Stanton Newman, City, University of London

June 28, 2013
July 3, 2013
August 4, 2016
July 2013
June 2016   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01891786 on Archive Site
  • Psycho-social impact of the intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    The impact of receiving genetic test results using a modified version of the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire.
Same as current
Not Provided
Not Provided
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.
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Type 2 Diabetes
  • 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.
  • No Intervention: Usual Care
    The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.
  • Active Comparator: Group Self-Management Intervention (SMI)
    Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.
    Intervention: Behavioral: Self-Management Intervention
  • Active Comparator: SMI + Risk Results
    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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 74 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
RRMR11-001 ( Other Grant/Funding Number: The Bupa Foundation )
Not Provided
Plan to Share IPD: No
Stanton Newman, City, University of London
City, University of London
University College, London
Principal Investigator: Stanton P Newman, PhD City, University of London
City, University of London
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP