title: Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The periodic health check-up has been a fundamental part of routine medical practice for decades, despite a lack of consensus regarding its value in health promotion and disease prevention. A large-scale Danish population-based preventive programme 'Check your health' was developed based on available evidence of screening and successive accepted treatment, prevention for diseases and health promotion, and is closely aligned with the current health care system.The objective of the 'Check your health' [CORE] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years, and to establish the cost-effectiveness.
  
  
  METHODS
  The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals. All individuals within a well-defined geographical area in the Central Denmark Region, Denmark (DK) were randomised to be offered a preventive health check (Intervention group, n = 5250) or to maintain routine access to healthcare until a delayed intervention (Comparison group, n = 5255). The programme consists of a health examination which yields an individual risk profile, and according to this participants are assigned to one of the following interventions: (a) referral to a health promoting consultation in general practice, (b) behavioural programmes at the local Health Centre, or (c) no need for follow-up.The primary outcomes at 4 years follow-up are: ten-year-risk of fatal cardiovascular event (Heart-SCORE model), physical activity level (self-report and cardiorespiratory fitness), quality of life (SF12), sick leave and labour market attachment. Cost-effectiveness will be evaluated according to life years gained, direct costs and total health costs. Intention to treat analysis will be performed.
  
  
  CONCLUSIONS
  Results from the largest Danish health check programme conducted within the current healthcare system, spanning the sectors which share responsibility for the individual, will provide a scientific basis to be used in the development of systems to optimise population health in the 21st century.
  
  
  BACKGROUND
  The trial has registered at ClinicalTrials.gov with an ID: NCT02028195 (7. March 2014).
authors.affiliation: Department of Public Health, Health Promotion and Health Services, Aarhus University, Bartholins Allé 2, 8000 Aarhus C, Denmark. htm@ph.au.dk.
authors.forename: Helle Terkildsen
authors.initials: HT
authors.lastname: Maindal
authors.forename: Henrik
authors.initials: H
authors.lastname: Støvring
authors.forename: Annelli
authors.initials: A
authors.lastname: Sandbaek
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D003718:Denmark; D004651:Employment; D005260:Female; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D010808:Physical Examination; D010809:Physical Fitness; D011237:Predictive Value of Tests; D011314:Preventive Health Services / Q000191:economics / Q000379:methods*; D011320:Primary Health Care / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D018582:Sick Leave; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome