Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

ACC 2024 Congress

Catch up on all the top stories and latest evidence in cardiology research with our ACC 2024 Congress hub page.
ADVANCED SEARCH
Log in
Top
BMC Public Health
Published in: BMC Public Health 1/2015

Open Access 01-12-2015 | Study protocol

Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour

Authors: Barbora Silarova, Joanne Lucas, Adam S. Butterworth, Emanuele Di Angelantonio, Christine Girling, Kathryn Lawrence, Stuart Mackintosh, Carmel Moore, Rupert A. Payne, Stephen J. Sharp, Guy Shefer, Zoe Tolkien, Juliet Usher-Smith, Matthew Walker, John Danesh, Simon Griffin

Published in: BMC Public Health | Issue 1/2015

Login to get access

Abstract

Background

Cardiovascular disease (CVD) remains the leading cause of death globally. Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions. An integral part of this approach is the use of CVD risk scores. Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies. We aim to evaluate short-term effects of providing different types of information about coronary heart disease (CHD) risk, alongside lifestyle advice, on health-related behaviours.

Methods/Design

In a parallel-group, open randomised trial, we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in England to either no intervention (control group) or to one of three active intervention groups: i) lifestyle advice only; ii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics; and iii) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics. The primary outcome is change in objectively measured physical activity. Secondary outcomes include: objectively measured dietary behaviours; cardiovascular risk factors; current medication and healthcare usage; perceived risk; cognitive evaluation of provision of CHD risk scores; and psychological outcomes. The follow-up assessment takes place 12 weeks after randomisation. The experiences, attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups.

Discussion

The INFORM study has been designed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours.

Trial registration

Current Controlled Trials ISRCTN17721237. Registered 12 January 2015.
Appendix
Available only for authorised users
Literature
1.
2.
3.
4.
5.
Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991;121(1 Pt 2):293–8.CrossRefPubMed
6.
Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, May M, Brindle P. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ. 2007;335(7611):136.CrossRefPubMedPubMedCentral
7.
Woodward M, Brindel P, Tunstall-Pedoe H. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart. 2007;93(2):172–6.CrossRefPubMed
8.
Conroy RM, Pyorala K, Fitzgerald AP, Sans S, Menotti A, De BG, et al. Estimation of ten–year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003;24(11):987–1003.CrossRefPubMed
9.
Ridker PM, Buring JE, Rifai N, Cook NR. Development and validation of improved algorithms for the assessment of global cardiovascular risk in women: the Reynolds Risk Score. JAMA. 2007;297(6):611–9.CrossRefPubMed
10.
JBS3 Board. Joint British Societies ‘consensus recommendations for the prevention of cardiovascular disease (JBS3). Heart. 2014;100 Suppl 2:ii1–ii67.CrossRef
11.
Goff Jr DC, Lloyd-Jones DM, Bennett G, O'Donnell CJ, Coady S, Robinson J, et al. ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2014;129(25 Suppl 2):S49–73.CrossRefPubMed
12.
NHS Employers and British Medical Association Quality and Outcomes Framework Guidance for GMS Contract 2011–12. London: The NHS Confederation (Employers) Company; 2011.
13.
Krogsbøll LT, Jørgensen KJ, Larsen CG, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345, e7191.CrossRefPubMedPubMedCentral
14.
Satish M. Coronary heart disease in clinical practice. London: Goldaming, Springer; 2005.
15.
Gaziano M, Ridker PM, Libby P. Primary and secondary prevention of coronary heart disease. In: Bonow RO, Mann DL, Zipes DP, Libby P, editors. Braunwald’s heart disease. A textbook of cardiovascular medicine. Philadelphia: Elsevier Saunders; 2012. p. 1010–35.CrossRef
16.
Rabar S, Harker M, O’Flynn N, Wierzbicki AS, Guideline Development Group. Lipid modification and cardiovascular risk assessment for the primary and secondary prevention of cardiovascular disease: summary of updated NICE guidance. BMJ. 2014;349:g4356.CrossRefPubMed
17.
18.
Brindle P, Beswick A, Fahey T, Ebrahim S. Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review. Heart. 2006;92(12):1752–9.CrossRefPubMedPubMedCentral
19.
Sheridan SL, Viera AJ, Krantz MJ, Ice CL, Steinman LE, Peters KE, et al. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med. 2010;170(3):230–9.CrossRefPubMed
20.
Wang C, Bowen DJ, Kardia SL. Research and practice opportunities at the intersection of health education, health behaviour and genomics. Health Educ Behav. 2005;32(5):686–701.CrossRefPubMed
21.
Institute of Medicine. Initial National priorities for Comparative Effectiveness research. Washington, DC: Institute of Medicine; 2009.
22.
Rosenstock IM. Adoption and maintenance of lifestyle modifications. Am J Prev Med. 1988;4(6):349–52.PubMed
23.
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;2010(10):CD007275.
24.
Moore C, Sambrook J, Walker M, Tolkien Z, Kaptoge S, Allen D, et al. The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial. Trials. 2014;15:363.CrossRefPubMedPubMedCentral
25.
26.
27.
Persell SD, Lloyd-Jones DM, Friesema EM, Cooper AJ, Baker DW. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial. J Gen Intern Med. 2013;28(4):554–60.CrossRefPubMed
28.
29.
D'Agostino Sr RB, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008;117(6):743–53.CrossRefPubMed
30.
Soureti A, Hurling R, Murray P, van Mechelen W, Cobain M. Evaluation of a cardiovascular disease risk assessment tool for the promotion of healthier lifestyles. Eur J Cardiovasc Prev Rehabil. 2010;17(5):519–23.CrossRefPubMed
31.
Carlsson AC, Wandell PE, Gigante B, Leander K, Hellenius ML, de Faire U. Seven modifiable lifestyle factors predict reduced risk for ischemic cardiovascular disease and all-cause mortality regardless of body mass index: A cohort study. Int J Cardiol. 2013;168(2):946–52.CrossRefPubMed
32.
Akesson A, Weismayer C, Newby PK, Wolk A. A combined effect of low-risk dietary and lifestyle behaviours in primary prevention of myocardial infarction in women. Arch Intern Med. 2007;167(19):2122–7.CrossRefPubMed
33.
Khaw KT, Wareham N, Bingham S, Welch A, Luben R, Day N. Combined impact of health behaviours and mortality in men and women: the EPIC-Norfolk prospective population study. PLoS Med. 2008;5(1), e12.CrossRefPubMedPubMedCentral
34.
35.
36.
37.
Day N, Oakes S, Luben R, Khaw KT, Bingham S, Welch A, et al. EPIC-Norfolk: study design and characteristics of the cohort. European Prospective Investigation of Cancer. Br J Cancer. 1999;80 Suppl 1:95–103.PubMed
38.
CARDIoGRAMplusC4D Consortium, Deloukas P, Kanoni S, Willenborg C, Farrall M, Assimes TL. Large-scale association analysis identifies new risk loci for coronary artery disease. Nat Genet. 2013;45(1):25–33.
39.
40.
Schunkert H, König IR, Kathiresan S, Reilly MP, Assimes TL, Holm H, et al. Large-scale association analysis identifies 13 new susceptibility loci for coronary artery disease. Nat Genet. 2011;43(4):333–8.CrossRefPubMedPubMedCentral
41.
Coronary Artery Disease (C4D) Genetics Consortium. A genome-wide association study in Europeans and South Asians identifies five new loci for coronary artery disease. Nat Genet. 2011;43(4):339–44.CrossRef
42.
IBC 50K CAD Consortium. Large-scale gene-centric analysis identifies novel variants for coronary artery disease. PLoS Genet. 2011;7(9):e1002260.CrossRef
43.
Fair AK, Murray PG, Thomas A, Cobain MR. Using hypothetical data to assess the effect of numerical format and context on perception of coronary heart disease risk. Am J Health Promot. 2008;22(4):291–6.CrossRefPubMed
44.
Lipkus IM, Samsa G, Rimer BK. General performance on a numeracy scale among highly educated samples. Med Decis Making. 2001;21(1):37–44.CrossRefPubMed
45.
Kirby M, Machen L. Impact on clinical practice of the Joint British Societies’ cardiovascular risk assessment tools. Int J Clin Pract. 2009;63(12):1683–92.CrossRefPubMed
46.
Lopez-Gonzalez AA, Aguilo A, Frontera M, Bennasar-Veny M, Campos I, Vicente-Herrero T, et al. Effectiveness of the Heart Age tool for improving modifiable cardiovascular risk factors in a Southern European population: a randomized trial. Eur J Prev Cardiol. 2015;22(3):389–96.CrossRefPubMed
47.
Hill S, Spink J, Cadilhac D, Edwards A, Kaufman C, Rogers S, et al. Absolute risk representation in cardiovascular disease prevention: comprehension and preferences of health care consumers and general practitioners involved in a focus group study. BMC Public Health. 2010;10:108.CrossRefPubMedPubMedCentral
48.
Knowles JW, Assimes TL, Kiernan M, Pavlovic A, Goldstein BA, Yank V, et al. Randomized trial of personal genomics for preventive cardiology: design and challenges. Circ Cardiovasc Genet. 2012;5(3):368–76.CrossRefPubMedPubMedCentral
49.
Sheridan SL, Behrend L, Vu MB, Meier A, Griffith JM, Pignone MP. Individuals’ responses to global CHD risk: a focus group study. Patient Educ Couns. 2009;76(2):233–9.CrossRefPubMedPubMedCentral
50.
Sheridan SL, Draeger LB, Pignone MP, Sloane PD, Samuel-Hodge C, Finkelstein EA, et al. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for Heart to health study. Contemp Clin Trials. 2013;36(2):394–405.CrossRefPubMedPubMedCentral
51.
Sheridan SL, Draeger LB, Pignone MP, Keyserling TC, Simpson Jr RJ, Rimer B, et al. A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies. BMC Health Serv Res. 2011;11:331.CrossRefPubMedPubMedCentral
52.
Trost SG, O’ Neil M. Clinical use of objective measures of physical activity. Br J Sports Med. 2014;48(3):178–81.CrossRefPubMed
53.
Rock CL, Flatt SW, Natarajan L, Thomson CA, Bardwell WA, Newman VA, et al. Plasma carotenoids and recurrence-free survival in women with a history of breast cancer. J Clin Oncol. 2005;23(27):6631–8.CrossRefPubMed
54.
Price CH, Tucker L, Griffin SJ, Holman RR. The impact of individualised cardiovascular disease (CVD) risk estimates and lifestyle advice on physical activity in individuals at high risk of CVD: a pilot 2 x 2 factorial understanding risk trial. Cardiovasc Diabetol. 2008;7:21.CrossRefPubMedPubMedCentral
55.
Ekelund U, Griffin SJ, Wareham NJ. Physical activity and metabolic risk in individuals with a family history of type 2 diabetes. Diabetes Care. 2007;30(2):337–42.CrossRefPubMed
56.
Godino JG, van Sluijs EMF, Marteau TM, Sutton S, Sharp SJ, Griffin SJ. Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial. BMC Public Health. 2012;12:444.CrossRefPubMedPubMedCentral
57.
Middlemass JB, Yazdani MF, Kai J, Standen PJ, Qureshi N. Introducing genetic testing for cardiovascular disease in primary care: a qualitative study. Br J Gen Pract. 2014;64(622):e282–9.CrossRefPubMed
58.
Meyer SB, Coveney J, Ward PR. A qualitative study of CVD management and dietary changes: problems of ‘too much’ and ‘contradictory’ information. BMC Fam Pract. 2014;15:25.CrossRefPubMedPubMedCentral
59.
White IR, Thompson SG. Adjusting for partially missing baseline measurements in randomized trials. Stat Med. 2005;24(7):993–1007.CrossRefPubMed
60.
Wareham NJ, Jakes RW, Rennie KL, Jo M, Hennings S, Day NE. Validity and repeatability of the EPIC-Norfolk Physical Activity Questionnaire. Int J Epidemiol. 2002;1:168–74.CrossRef
61.
Knapp M, Beecham J. Reduced list costings: examination of an informed short cut in mental health research. Health Econ. 1993;4:313–22.CrossRef
62.
Diefenbach MA, Weinstein ND, O'Reilly J. Scales for assessing perceptions of health hazard susceptibility. Health Educ Res. 1983;8:181–92.CrossRef
63.
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: Validity of a Two-Item Depression Screener. Med Care. 2003;41:1284–94.CrossRefPubMed
64.
Watson M, Lloyd S, Davidson J, Meyer L, Ebbs S, Murday V. The impact of genetic counselling on risk perception and mental health in women with a family history of breast cancer. Br J Cancer. 1999;79:868–74.CrossRefPubMedPubMedCentral
65.
Schwartz LM, Woloshin S, Black WC, Welch HG. The role of numeracy in understanding the benefit of screening mammography. Ann Intern Med. 1997;127:96–972.
66.
Ware JE, Kosinski M, Keller SK. SF-36® Physical and Mental Health Summary Scales: A User’s Manual. Boston, MA: The Health Institute; 1994.
67.
68.
Broadbent E, Petrie KJ, Main J, Weinman J. The Brief Illness Perception Questionnaire. J Psychosom Res. 2006;60(6):631–7.CrossRefPubMed
69.
Sanderson SC, Persky S, Michie S. Psychological and behavioral responses to genetic test results indicating increased risk of obesity: Does the causal pathway from gene to obesity matter? Public Health Genomics. 2010;13(1):34–47.CrossRefPubMed
70.
Zimet G, Dahlem N, Zimet S, Farley G. The Multidimensional Scale of Perceived Social Support. J Pers Assess. 1988;52:30–41.CrossRef
71.
Peretti-Watel P, L’Haridon O, Seror V. Time preferences, socioeconomic status and smokers’ behaviour, attitudes and risk awareness. Eur J Public Health. 2013;23(5):783–8.CrossRefPubMed
72.
Lundberg O, Nyström Peck M. A simplified way of measuring sense of coherence: experiences from a population survey in Sweden. Eur J Public Health. 1995;5:56–9.CrossRef
Metadata
Title
Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour
Authors
Barbora Silarova
Joanne Lucas
Adam S. Butterworth
Emanuele Di Angelantonio
Christine Girling
Kathryn Lawrence
Stuart Mackintosh
Carmel Moore
Rupert A. Payne
Stephen J. Sharp
Guy Shefer
Zoe Tolkien
Juliet Usher-Smith
Matthew Walker
John Danesh
Simon Griffin
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-015-2192-5

Other articles of this Issue 1/2015

BMC Public Health 1/2015 Go to the issue

Research article

Challenges to the surveillance of non-communicable diseases – a review of selected approaches

Research article

Associations between toddlers’ and parents’ BMI, in relation to family socio-demography: a cross-sectional study

Research article

A cross-sectional analysis of the geographic distribution and causes of maternal mortality in South Africa: 2002–2006

Research article

Using the health belief model to predict breast self examination among Saudi women

Research article

Regional disparities in interferon therapy for chronic hepatitis C in Japan: a nationwide retrospective cohort study

Research article

Use of mobile phone consultations during home visits by Community Health Workers for maternal and newborn care: community experiences from Masindi and Kiryandongo districts, Uganda