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Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01891786
First Posted: July 3, 2013
Last Update Posted: August 4, 2016
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.
Collaborator:
University College, London
Information provided by (Responsible Party):
Stanton Newman, City University, London
  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
Intervention Model: Parallel Assignment
Masking: None (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 Stanton Newman, City University, London:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 211
Study Start Date: July 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891786


Locations
United Kingdom
Addison House Surgery
Harlow, Essex, United Kingdom, CM20 1DS
Church Street Surgery
Ware, Essex, United Kingdom, SG12 9EG
Dolphin House Surgery
Ware, Essex, United Kingdom, SG12 9HJ
Wallace House Surgery
Hertford, Hertfordshire, United Kingdom, SG14 1HZ
Cambridgeshire Community Services NHS Trust
Cambridgeshire, United Kingdom, PE27 4LG
Chesterfield Drive Surgery
Ipswich, United Kingdom, IP1 6DW
Martlesham health Surgery
Ipswich, United Kingdom, IP5 3SL
Dr Taylor and Partners
Woodbridge Suffolk, United Kingdom, IP12 1EE
The Peninsula Practice
Woodbridge Suffolk, United Kingdom, IP12 2NN
Wickham Market Medical Centre
Woodbridge Suffolk, United Kingdom, IP13 0SB
Sponsors and Collaborators
City, University of London
University College, London
Investigators
Principal Investigator: Stanton P Newman, PhD City, University of London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanton Newman, Professor, City University, London
ClinicalTrials.gov Identifier: NCT01891786     History of Changes
Other Study ID Numbers: 12/EE/0437
RRMR11-001 ( Other Grant/Funding Number: The Bupa Foundation )
First Submitted: June 28, 2013
First Posted: July 3, 2013
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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