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

Volumn 16, Issue 1, 2015, Pages

  Davies, Anna K ^a   McGale, Nadine ^a   Humphries, Steve E ^b   Hirani, Shashivadan P ^a   Beaney, Katherine E ^b   Bappa, Dauda A S ^b   McCabe, John G ^c   Newman, Stanton P ^a  

^a CITY UNIVERSITY   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c Wallace House GP Surgery   (United Kingdom)

Author keywords

Diabetes; Genetic testing; Healthy eating; Medication adherence; Physical activity; RCT protocol; Self management; UKPDS

Indexed keywords

CHOLESTEROL; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN; GENETIC MARKER;

ADULT; AGED; ARTICLE; BLOOD PRESSURE; BODY MASS; BODY WEIGHT; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL PROTOCOL; COGNITION; COHORT ANALYSIS; CONTROLLED STUDY; FEEDING BEHAVIOR; GENERAL PRACTICE; GLYCEMIC CONTROL; HEALTH BEHAVIOR; HEALTH PROMOTION; HEMOGLOBIN DETERMINATION; HUMAN; INFORMATION DISSEMINATION; ISCHEMIC HEART DISEASE; LIFESTYLE MODIFICATION; MEDICAL INFORMATION; MEDICAL RECORD; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT CARE PLANNING; PATIENT EDUCATION; PERSONALIZED MEDICINE; PHYSICAL ACTIVITY; PROBLEM SOLVING; PSYCHOLOGICAL WELL BEING; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RISK MANAGEMENT; SELF CARE; SELF REPORT; TREATMENT DURATION; UNITED KINGDOM; ADVERSE EFFECTS; ATTITUDE TO HEALTH; CLINICAL TRIAL; COMPLICATION; CORONARY DISEASE; COUNSELING; DIABETES MELLITUS, TYPE 2; DIET; ENGLAND; EXERCISE; FEMALE; GENETIC MARKER; GENETIC PREDISPOSITION; GENETICS; GROUP PROCESS; MALE; METHODOLOGY; MIDDLE AGED; MOTIVATION; MULTICENTER STUDY; PATIENT COMPLIANCE; PHENOTYPE; PSYCHOLOGY; QUALITY OF LIFE; RISK FACTOR; RISK REDUCTION; TIME FACTOR; TREATMENT OUTCOME;

ADULT; AGED; CLINICAL PROTOCOLS; COGNITION; CORONARY DISEASE; COUNSELING; DIABETES MELLITUS, TYPE 2; DIET; ENGLAND; EXERCISE; FEMALE; GENETIC MARKERS; GENETIC PREDISPOSITION TO DISEASE; GROUP PROCESSES; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; MALE; MIDDLE AGED; MOTIVATION; PATIENT COMPLIANCE; PHENOTYPE; PRECISION MEDICINE; QUALITY OF LIFE; RESEARCH DESIGN; RISK FACTORS; RISK REDUCTION BEHAVIOR; SELF CARE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84949208648     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-1073-7     Document Type: Article

References (36)

1. Diabetes UK. Diabetes facts and stats. 2014. https://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf. Accessed 01 June 2015
2. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047-53.
3. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-86.
4. Morrish NJ, Wang SL, Stevens LK, Fuller JH, Keen H. Mortality and causes of death in the WHO multinational study of vascular disease in diabetes. Diabetologia. 2001;44 Suppl 2:S14-21.
5. National Institute for Health and Care Excellence. Quality Outcomes Framework for Diabetes Mellitus. Guideline NM27. 2011. http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/QOF/2015%20-%2016/2015%2016%20QOF%20guidance%20for%20stakeholders.pdf. Accessed 01 June 2015.
6. National Institute for Health and Care Excellence. Type 2 diabetes: the management of type 2 diabetes: NICE clinical guideline 87. NICE. 2009. http://www.nice.org.uk/guidance/cg87. Accessed 25 May 2015.
7. Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet. 2004;364:1523-37.
8. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25:1159-71.
9. Heinrich E, Schaper NC, de Vries NK. Self-management interventions for type 2 diabetes: a systematic review. Eur Diabetes Nurs. 2010;7:71-6.
10. Worswick J, Wayne SC, Bennett R, Fiander M, Mayhew A, Weir MC, et al. Improving quality of care for persons with diabetes: an overview of systematic reviews - what does the evidence tell us? Syst Rev. 2013;2:26.
11. Padgett D, Mumford E, Hynes M, Carter R. Meta-analysis of the effects of educational and psychosocial interventions on management of diabetes mellitus. J Clin Epidemiol. 1988;41:1007-30.
12. Bandura A, Adams NE, Beyer J. Cognitive processes mediating behavioral change. J Pers Soc Psychol. 1977;35:125-39.
13. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84:191-215.
14. Steed L, Lankester J, Barnard M, Earle K, Hurel S, Newman S. Evaluation of the UCL diabetes self-management programme (UCL-DSMP): a randomized controlled trial. J Health Psychol. 2005;10:261-76.
15. Michie S. Interventions to change health behaviours: evidence-based or evidence-inspired? Psychol Health. 2004;19:29-49.
16. Schwarzer R. Self-efficacy: thought control of action. Washington, DC: Hemisphere Pub. Corp; 1992.
17. Schwarzer R, Renner B. Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychol. 2000;19:487-95.
18. Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: a longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006;11:23-37.
19. UK Prospective Diabetes Study (UKPDS) VIII. Study design, progress and performance. Diabetologia. 1991;34:877-90.
20. Tercyak KP, O'Neill SC, Roter DL, McBride CM. Bridging the communication divide: a role for health psychology in the genomic era. Prof Psychol Res Pr. 2012;43:568-75.
21. Beaney KE, Cooper JA, Shahid SU, Ahmed W, Qamar R, Drenos F, et al. Clinical utility of a coronary heart disease risk prediction gene score in UK healthy middle-aged men and in the Pakistani population. PLoS One. 2015;10:e0130754.
22. Collins RE, Wright AJ, Marteau TM. Impact of communicating personalized genetic risk information on perceived control over the risk: a systematic review. Genet Med. 2011;13:273-7.
23. Kaphingst KA, McBride CM, Wade C, Alford SH, Reid R, Larson E, et al. Patients' understanding of and responses to multiplex genetic susceptibility test results. Genet Med. 2012;14:681-7.
24. Marteau TM, French DP, Griffin SJ, Prevost AT, Sutton S, Watkinson C, et al. Effects of communicating DNA-based disease risk estimates on risk-reducing behaviours. Cochrane Database Syst Rev. 2010;10:CD007275.
25. Dallal, GE. http://www.jerrydallal.com/random/assign.htm. 2008. Accessed 04 Jan 2014.
26. Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46:81-95.
27. Dhamrait SS, Stephens JW, Cooper JA, Acharya J, Mani AR, Moore K, et al. Cardiovascular risk in healthy men and markers of oxidative stress in diabetic men are associated with common variation in the gene for uncoupling protein 2. Eur Heart J. 2004;25:468-75.
28. Stevens RJ, Kothari V, Adler AI, Stratton IM. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Sci (Lond). 2001;101:671-9.
29. Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23:943-50.
30. Renner B, Schwarzer R. Risk and health behaviors. Documentation of the scales of the research project: "Risk appraisal consequences in Korea" (RACK). http://userpage.fu-berlin.de/gesund/RACK-English.pdf. Berlin FU. 2003.
31. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361-70.
32. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002;52:69-77.
33. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220-33.
34. Chung WW, Chen CA, Cupples LA, Roberts JS, Hiraki SC, Nair AK, et al. A new scale measuring psychologic impact of genetic susceptibility testing for Alzheimer disease. Alzheimer Dis Assoc Disord. 2009;23:50-6.
35. Newman SP, Cooke D, Casbard A, Walker S, Meredith S, Nunn A, et al. A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE). Health Technol Assess. 2009;13:1-194.
36. Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Beh Res Methods. 2009;41:1149-60.