Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

August 3, 2016 updated by: Stanton Newman, City, University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridgeshire, United Kingdom, PE27 4LG
        • Cambridgeshire Community Services NHS Trust
      • Ipswich, United Kingdom, IP1 6DW
        • Chesterfield Drive Surgery
      • Ipswich, United Kingdom, IP5 3SL
        • Martlesham health Surgery
      • Woodbridge Suffolk, United Kingdom, IP12 1EE
        • Dr Taylor and Partners
      • Woodbridge Suffolk, United Kingdom, IP12 2NN
        • The Peninsula Practice
      • Woodbridge Suffolk, United Kingdom, IP13 0SB
        • Wickham Market Medical Centre
    • Essex
      • Harlow, Essex, United Kingdom, CM20 1DS
        • Addison House Surgery
      • Ware, Essex, United Kingdom, SG12 9EG
        • Church Street Surgery
      • Ware, Essex, United Kingdom, SG12 9HJ
        • Dolphin House Surgery
    • Hertfordshire
      • Hertford, Hertfordshire, United Kingdom, SG14 1HZ
        • Wallace House Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Collaborators

University College, London

Investigators

  • Principal Investigator: Stanton P Newman, PhD, City, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/EE/0437
  • RRMR11-001 (Other Grant/Funding Number: The Bupa Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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