Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Type 2 Diabetes
Behavioral: Self-Management Intervention
Behavioral: Risk Result

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by City University, London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 312
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891786

Contacts
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

Locations
United Kingdom
Addison House Surgery Recruiting
Harlow, Essex, United Kingdom, CM20 1DS
Church Street Surgery Recruiting
Ware, Essex, United Kingdom, SG12 9EG
Dolphin House Surgery Recruiting
Ware, Essex, United Kingdom, SG12 9HJ
Wallace House Surgery Recruiting
Hertford, Hertfordshire, United Kingdom, SG14 1HZ
Contact: Gerald McCabe, BSc(Hons) MB    01992 550541      
Principal Investigator: Gerald McCabe, 01992 550541         
Sponsors and Collaborators
City University, London
University College, London
Investigators
Principal Investigator: Stanton P Newman, PhD City University, London
  More Information

Additional Information:
No publications provided

Responsible Party: Stanton Newman, Professor, City University, London
ClinicalTrials.gov Identifier: NCT01891786     History of Changes
Other Study ID Numbers: 12/EE/0437, RRMR11-001
Study First Received: June 28, 2013
Last Updated: March 19, 2014
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014