Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3617 (Published 09 June 2014) Cite this as: BMJ 2014;348:g3617
- Torben Jørgensen, director and professor123,
- Rikke Kart Jacobsen, statistician1,
- Ulla Toft, senior researcher1,
- Mette Aadahl, senior researcher1,
- Charlotte Glümer, professor13,
- Charlotta Pisinger, associate professor12
- 1Research Centre for Prevention and Health, Building 84/85, Glostrup Hospital, DK-2600 Glostrup, Denmark
- 2Faculty of Health Science, University of Copenhagen, Denmark
- 3Faculty of Medicine, University of Aalborg, Denmark
- Correspondence to: T Jørgensen torben.joergensen{at}regionh.dk
- Accepted 5 May 2014
Abstract
Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level.
Design Randomised controlled community based trial.
Setting Suburbs of Copenhagen, Denmark
Participants 59 616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group (n=11 629) and a control group (n=47 987).
Intervention The intervention group was invited for screening, risk assessment, and lifestyle counselling up to four times over a five year period. All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits (at baseline and after one and three years); those at high risk of ischaemic heart disease, according to predefined criteria, were furthermore offered six sessions of group based lifestyle counselling on smoking cessation, diet, and physical activity. After five years all were invited for a final counselling session. Participants were referred to their general practitioner for medical treatment, if relevant. The control group was not invited for screening.
Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group. Secondary outcome measures were stroke, combined events (ischaemic heart disease, stroke, or both), and mortality.
Results 6091 (52.4%) people in the intervention group participated at baseline. Among 5978 people eligible at five year follow-up (59 died and 54 emigrated), 4028 (67.4%) attended. A total of 3163 people died in the 10 year follow-up period. Among 58 308 without a history of ischaemic heart disease at baseline, 2782 developed ischaemic heart disease. Among 58 940 without a history of stroke at baseline, 1726 developed stroke. No significant difference was seen between the intervention and control groups in the primary end point (hazard ratio for ischaemic heart disease 1.03, 95% confidence interval 0.94 to 1.13) or in the secondary endpoints (stroke 0.98, 0.87 to 1.11; combined endpoint 1.01, 0.93 to 1.09; total mortality 1.00, 0.91 to 1.09).
Conclusion A community based, individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease, stroke, or mortality at the population level after 10 years.
Trial registration Clinical trials NCT00289237.
Footnotes
We thank the whole Inter99-staff and all people participating in the study. The Inter99 study was initiated by Torben Jorgensen (principal investigator), Knut Borch-Johnsen (principal investigator on the diabetes part), Troels Thomsen, and Hans Ibsen. The current steering committee of the Inter99 study comprises Torben Jorgensen (principal investigator) and Charlotta Pisinger.
Contributors: TJ was responsible for the conception and design of the study. TJ, CG, and CP were involved in the design of the study and development of the intervention. TJ, RKJ and CP analysed data and wrote the first draft of the manuscript. All authors discussed data analyses and interpretation and contributed to subsequent versions of the manuscript, and all critically revised the manuscript and approved the final version of the manuscript. TJ is the guarantor.
Funding: The Inter99 study was funded by the Danish Research Councils, Health Foundation, Danish Centre for Evaluation and Health Technology Assessment, Copenhagen County, Danish Heart Foundation, Ministry of Health and Prevention, Association of Danish Pharmacies, Augustinus Foundation, Novo Nordisk, Velux Foundation, Becket Foundation, and Ib Henriksens Foundation. The researchers are independent of the founders, who had no influence on study design or conduct, analyses, or interpretation of results.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work other than those listed above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the Regional Scientific Ethics Committee (KA 98 155) and the Danish Data Protection Agency.
Transparency: The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported. No important aspects of the study have been omitted, and any discrepancies from the study as planned have been explained.
Data sharing: Technical appendix, statistical codes, and dataset are available from the corresponding author.
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