Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
211 participants
INTERVENTIONAL
2013-07-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usual Care
The participant's General practitioner (GP) practice and/or practice nurse will provide care as normal for their patient.
No interventions assigned to this group
Group Self-Management Intervention (SMI)
Participants will be asked to attend a total of 4 SMI sessions delivered on a weekly basis.
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
SMI + Risk Results
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
74 Years
ALL
No
Sponsors
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University College, London
OTHER
City, University of London
OTHER
Responsible Party
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Stanton Newman
Professor
Principal Investigators
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Stanton P Newman, PhD
Role: PRINCIPAL_INVESTIGATOR
City, University of London
Locations
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Addison House Surgery
Harlow, Essex, United Kingdom
Church Street Surgery
Ware, Essex, United Kingdom
Dolphin House Surgery
Ware, Essex, United Kingdom
Wallace House Surgery
Hertford, Hertfordshire, United Kingdom
Cambridgeshire Community Services NHS Trust
Cambridgeshire, , United Kingdom
Chesterfield Drive Surgery
Ipswich, , United Kingdom
Martlesham health Surgery
Ipswich, , United Kingdom
Dr Taylor and Partners
Woodbridge Suffolk, , United Kingdom
The Peninsula Practice
Woodbridge Suffolk, , United Kingdom
Wickham Market Medical Centre
Woodbridge Suffolk, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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RRMR11-001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
12/EE/0437
Identifier Type: -
Identifier Source: org_study_id
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