Clinical trial NCT01891786: Coronary Heart Disease Risk in Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Type 2 Diabetes
Lead sponsor: City, University of London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2013-07-03
Enrollment: 211
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Coronary heart disease 10 year risk
timeFrame: 12 months
Secondary outcomes:
measure: Psycho-social impact of the intervention
timeFrame: 12 months
measure: Health behaviour impact of the intervention
timeFrame: 12 months
measure: Impact of receiving genetic results
timeFrame: 6 months
Other outcomes:
Locations:
city: Harlow
country: United Kingdom
facility: Addison House Surgery
state: Essex
city: Ware
country: United Kingdom
facility: Church Street Surgery
state: Essex
city: Ware
country: United Kingdom
facility: Dolphin House Surgery
state: Essex
city: Hertford
country: United Kingdom
facility: Wallace House Surgery
state: Hertfordshire
city: Cambridgeshire
country: United Kingdom
facility: Cambridgeshire Community Services NHS Trust
city: Ipswich
country: United Kingdom
facility: Chesterfield Drive Surgery
city: Ipswich
country: United Kingdom
facility: Martlesham health Surgery
city: Woodbridge Suffolk
country: United Kingdom
facility: Dr Taylor and Partners
city: Woodbridge Suffolk
country: United Kingdom
facility: The Peninsula Practice
city: Woodbridge Suffolk
country: United Kingdom
facility: Wickham Market Medical Centre
Study officials:
affiliation: City, University of London
name: Stanton P Newman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaney KE, Ward CE, Bappa DA, McGale N, Davies AK, Hirani SP, Li K, Howard P, Vance DR, Crockard MA, Lamont JV, Newman S, Humphries SE. A 19-SNP coronary heart disease gene score profile in subjects with type 2 diabetes: the coronary heart disease risk in type 2 diabetes (CoRDia study) study baseline characteristics. Cardiovasc Diabetol. 2016 Oct 3;15(1):141. doi: 10.1186/s12933-016-0457-7.
citation: Davies AK, McGale N, Humphries SE, Hirani SP, Beaney KE, Bappa DA, McCabe JG, Newman SP. Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial. Trials. 2015 Dec 2;16:547. doi: 10.1186/s13063-015-1073-7.