Coronary Heart DiseaseCORDIANCT01891786
Coronary Heart Disease Risk in Type 2 Diabetes
A study testing Self-Management Intervention and Risk Result in people with Coronary Heart Disease and Type 2 Diabetes, run by City, University of London at 10 sites in United Kingdom.
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)… Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Coronary Heart Disease, Type 2 Diabetes
- What is being tested?
- Self-Management Intervention and Risk Result
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Jul 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Cambridgeshire Community Services NHS Trust
Cambridgeshire, PE27 4LG
Addison House Surgery
Harlow, Essex, CM20 1DS
Wallace House Surgery
Hertford, Hertfordshire, SG14 1HZ
Chesterfield Drive Surgery
Ipswich, IP1 6DW
Martlesham health Surgery
Ipswich, IP5 3SL
Church Street Surgery
Ware, Essex, SG12 9EG
Dolphin House Surgery
Ware, Essex, SG12 9HJ
Dr Taylor and Partners
Woodbridge Suffolk, IP12 1EE
The Peninsula Practice
Woodbridge Suffolk, IP12 2NN
Wickham Market Medical Centre
Woodbridge Suffolk, IP13 0SB
About this study
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.
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.
- Conditions
- Coronary Heart Disease, Type 2 Diabetes
- Being tested
- Self-Management Intervention, Risk Result
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management InterventionBehavioural
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 ResultBehavioural
Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 | Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis. Receives: Behavioral: Self-Management Intervention |
| SMI + Risk Results | Active comparator | 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. Receives: Behavioral: Self-Management Intervention; Behavioral: Risk Result |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary heart disease 10 year risk
Coronary heart disease 10 year risk as assessed using the United Kingdon Prospective Diabetes Study (UKPDS) Risk Calculator
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Stanton Newman, City, University of London
- Investigators
- Stanton P Newman, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891786
- Sponsor's protocol ID
- 12/EE/0437
- Other IDs
- RRMR11-001
- Acronym
- CORDIA
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27716211Davies 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.
PubMed 26631181
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01891786
- Acronym / sponsor ID
- CORDIA / 12/EE/0437
- Conditions
- Coronary Heart Disease, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 | Behavioral: Self-Management InterventionParticipants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis. |
| SMI + Risk Results | Active comparator | Behavioral: Self-Management Intervention, Behavioral: Risk ResultThe 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. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management InterventionThe 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 | Behavioural | Group Self-Management Intervention (SMI), SMI + Risk Results |
| Risk ResultParticipants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD. | Behavioural | SMI + Risk Results |
Primary outcome
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
3 secondary outcomes
Psycho-social impact of the intervention
Time frame: 12 months
Health behaviour impact of the intervention
Time frame: 12 months
Impact of receiving genetic results
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Derived from this study: PubMed 27716211Beaney 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.
- Derived from this study: PubMed 26631181Davies 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanton P Newman, PhD principal investigator
City, University of London
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Intervention and Risk Result in people with Coronary Heart Disease and Type 2 Diabetes, run by City, University of London at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary heart disease 10 year risk (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01891786, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.