title: 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.
abstract: BACKGROUND
  Many patients with type 2 diabetes fail to achieve good glycaemic control. Poor control is associated with complications including coronary heart disease (CHD). Effective self-management and engagement in health behaviours can reduce risks of complications. However, patients often struggle to adopt and maintain these behaviours. Self-management interventions have been found to be effective in improving glycaemic control. Recent developments in the field of genetics mean that patients can be given personalised information about genetic- and lifestyle-associated risk of developing CHD. Such information may increase patients' motivation to engage in self-management. The Coronary Risk in Diabetes (CoRDia) trial will compare the effectiveness of a self-management intervention, with and without provision of personalised genetic- and lifestyle-associated risk information, with usual care, on clinical and behavioural outcomes, the cognitive predictors of behaviour, and psychological wellbeing.
  
  
  METHODS
  Participants will be adults aged 25-74 years registered with general practices in the East of England, diagnosed with type 2 diabetes, with no history of heart disease, and with a glycated haemoglobin level of ≥6.45% (47 mmol/mol). Consenting participants will be randomised to one of three arms: usual care control, group self-management only, group self-management plus personalised genetic- and lifestyle-associated risk information. The self-management groups will receive four weekly 2-hour group sessions, focusing on knowledge and information sharing, problem solving, goal setting and action planning to promote medication adherence, healthy eating, and physical activity. Primary outcomes are glycaemic control and CHD risk. Clinical data will be collected from GP records, including HbA1c, weight, body mass index, blood pressure, and HDL and total cholesterol. Self-reported health behaviours, including medication adherence, healthy eating and physical activity, and cognitive outcomes will be assessed by questionnaire. Measures will be taken at baseline, 3 months (questionnaire only), 6 months and 12 months post-baseline.
  
  
  CONCLUSIONS
  This study will determine whether the addition of personalised genetic- and lifestyle-associated CHD risk information to a group self-management intervention improves diabetes control and CHD risk compared with group self-management and usual care. Effectiveness of the combined intervention on health behaviours cognitions theorised to predict them, and psychological outcomes will also be investigated.
  
  
  BACKGROUND
  This study has been registered at ClinicalTrials.gov; registration identifier NCT01891786 , registered 28 June 2013.
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. Anna.Davies.2@city.ac.uk.
authors.forename: Anna K
authors.initials: AK
authors.lastname: Davies
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. nadine.mcgale.1@city.ac.uk.
authors.forename: Nadine
authors.initials: N
authors.lastname: McGale
authors.affiliation: Centre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. steve.humphries@ucl.ac.uk.
authors.forename: Steve E
authors.initials: SE
authors.lastname: Humphries
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. shashi.hirani.1@city.ac.uk.
authors.forename: Shashivadan P
authors.initials: SP
authors.lastname: Hirani
authors.affiliation: Centre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. katherine.beaney.12@ucl.ac.uk.
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Beaney
authors.affiliation: Centre for Cardiovascular Genetics, British Heart Foundation Laboratories, Institute of Cardiovascular Science, University College London, Gower Street, London, WC1E 6BT, UK. d.bappa@ucl.ac.uk.
authors.forename: Dauda A S
authors.initials: DA
authors.lastname: Bappa
authors.affiliation: Wallace House GP Surgery, 5-11 St Andrew Street, Hertford, Hertfordshire, SG14 1HZ, UK. gerry.mccabe@nhs.net.
authors.forename: John G
authors.initials: JG
authors.lastname: McCabe
authors.affiliation: Centre for Health Services Research, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, UK. Stanton.newman.1@city.ac.uk.
authors.forename: Stanton P
authors.initials: SP
authors.lastname: Newman
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003071:Cognition; D003327:Coronary Disease / Q000175:diagnosis / Q000209:etiology / Q000235:genetics / Q000517:prevention & control* / Q000523:psychology; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000235:genetics / Q000523:psychology / Q000628:therapy*; D004032:Diet / Q000009:adverse effects; D004739:England; D015444:Exercise; D005260:Female; D005819:Genetic Markers; D020022:Genetic Predisposition to Disease; D006126:Group Processes; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010349:Patient Compliance; D010641:Phenotype; D057285:Precision Medicine; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005819:Genetic Markers