Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

This study is currently recruiting participants.
Verified March 2014 by City University, London
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Stanton Newman, City University, London
ClinicalTrials.gov Identifier:
NCT01891786
First received: June 28, 2013
Last updated: March 19, 2014
Last verified: March 2014

June 28, 2013
March 19, 2014
July 2013
September 2015   (final data collection date for primary outcome measure)
Coronary heart disease 10 year risk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Psycho-social impact of the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
    Interventions:
    • Behavioral: Self-Management Intervention
    • Behavioral: Risk Result
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
312
September 2015
September 2015   (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
Both
25 Years to 70 Years
No
Contact: Nadine McGale, PhD 0044 (0) 207 040 0888 nadine.mcgale.1@city.ac.uk
Contact: Anna K Davies, PhD 0044 (0) 207 040 0882 anna.davies.2@city.ac.uk
United Kingdom
 
NCT01891786
12/EE/0437, RRMR11-001
Yes
Stanton Newman, City University, London
City University, London
University College, London
Principal Investigator: Stanton P Newman, PhD City University, London
City University, London
March 2014

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