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Completed

NCT Number: NCT01891786

Coronary Heart Disease Risk in 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.

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Key information

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addison House Surgery, Harlow, Essex, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management Intervention

Behavioral

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

Risk Result

Behavioral

Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

City, University of London

Other

Collaborators

  • University College, London

Registry information

Official study 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.

Acronym: CORDIA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 3, 2013
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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