Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

City, University of London

Status: Completed

Conditions: Coronary Heart Disease; Type 2 Diabetes

Treatments: Behavioral: Risk Result; Behavioral: Self-Management Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01891786

RRMR11-001 (Other Grant/Funding Number)

12/EE/0437

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 25 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 3 patient groups

Usual Care

No Intervention group

Description:

The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.

Group Self-Management Intervention (SMI)

Active Comparator group

Description:

Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.

Treatment:

Behavioral: Self-Management Intervention

SMI + Risk Results

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Management Intervention

Behavioral: Risk Result