Coronary Heart Disease Risk in Type 2 Diabetes (CORDIA)

C

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)

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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