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NCT01891786 Clinical Trial

Coronary Heart Disease Risk in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— CORDIA  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01891786
Other study ID # 12/EE/0437
Secondary ID RRMR11-001
Status Completed
Phase N/A
First received June 28, 2013
Last updated August 3, 2016
Start date July 2013
Est. completion date June 2016

Study information
Verified date August 2016
Source City University, London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 211
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 74 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Cambridgeshire Community Services NHS Trust Cambridgeshire
United Kingdom Addison House Surgery Harlow Essex
United Kingdom Wallace House Surgery Hertford Hertfordshire
United Kingdom Chesterfield Drive Surgery Ipswich
United Kingdom Martlesham health Surgery Ipswich
United Kingdom Church Street Surgery Ware Essex
United Kingdom Dolphin House Surgery Ware Essex
United Kingdom Dr Taylor and Partners Woodbridge Suffolk
United Kingdom The Peninsula Practice Woodbridge Suffolk
United Kingdom Wickham Market Medical Centre Woodbridge Suffolk

Sponsors (2)
Lead Sponsor Collaborator
City University, London University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coronary heart disease 10 year risk Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator 12 months No
Secondary Psycho-social impact of the intervention 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 No
Secondary Health behaviour impact of the intervention 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 No
Secondary Impact of receiving genetic results The impact of receiving genetic test results using a modified version of the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. 6 months No
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