Clinical trial NCT02028195: Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme
Official title: The CORE-trial: a Pragmatic Randomized Controlled Trial in Primary Care Investigating Effectiveness and Cost-effectiveness of the Check Your Health Preventive Programme Offered Population-wide to 30-49 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Promotion
Cardiovascular Disease
Physical Inactivity
Selfreported Quality of Health
Mental Health
Keywords: Health check
Health promotion
prevention diabetes
prevention cardiovascular disease
mental health
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Tryg Danmark
name: Randers Municipality, Denmark
name: Region MidtJylland Denmark
First posted: 2014-01-07
Enrollment: 11000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Check your health is a prevention intervention designed to create awareness and action on health condition with focus at physical activity at a population-level to 30-49 years of age. It consists of a behavioural and clinical examination followed by either (I) referral to a health promoting consultation in general practice (II) targeted behavioural programmes at the local Health Centre or (III ) no need for follow-up; stratified after risk-profile. The CORE trial (Check your health) aim to investigate effectiveness on health and social outcomes of the preventive health check and to establish the cost-effectiveness according to life years gained; direct costs and total health costs. A pragmatic cluster randomised controlled trial has been established to meet the aims and in total 10.600 individuals from 35 practices have been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively. The group offered the preventive health check in 2013-14 will constitute the intervention group and the group examined in 2017 - 18 the control group. A follow up of the intervention group in 2017 - 18 will provide data for the intention to treat analysis revealing the effect. Outcome measures are level of physical activity, risk of getting cardiovascular disease, sick leave and labor market attachment.


Eligibility criteria: Inclusion Criteria:

* all citizens living in Randers Municipality aged 30-49 on 1 January 2012, identified in the Danish Civil Registers (DCR) and randomised for health check in 2013 or 2017.

Exclusion Criteria:

* Terminal illness, reported by their GP is exclusion criteria for receiving invitation.

Primary outcomes:
measure: Physical activity
timeFrame: 4 years
measure: Modelled cardiovascular risk
timeFrame: 4 years
measure: Health related quality of life
timeFrame: 4 years
measure: Functional capacity
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
measure: Health economy assessment
timeFrame: 4 years
Locations:
city: Aarhus
country: Denmark
facility: Department of Public Health
Study officials:
affiliation: University of Aarhus
name: Annelli Sandbæk, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Helle T Maindal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerregaard AL, Dalsgaard EM, Bruun NH, Norman K, Witte DR, Stovring H, Maindal HT, Sandbaek A. Effectiveness of the population-based 'check your health preventive programme' conducted in a primary care setting: a pragmatic randomised controlled trial. J Epidemiol Community Health. 2022 Jan;76(1):24-31. doi: 10.1136/jech-2021-216581. Epub 2021 Jun 18.
citation: Geyti C, Christensen KS, Dalsgaard EM, Bech BH, Gunn J, Maindal HT, Sandbaek A. Factors associated with non-initiation of mental healthcare after detection of poor mental health at a scheduled health check: a cohort study. BMJ Open. 2020 Oct 16;10(10):e037731. doi: 10.1136/bmjopen-2020-037731.
citation: Geyti C, Dalsgaard EM, Sandbaek A, Maindal HT, Christensen KS. Initiation and cessation of mental healthcare after mental health screening in primary care: a prospective cohort study. BMC Fam Pract. 2018 Nov 17;19(1):176. doi: 10.1186/s12875-018-0864-9.
citation: Maindal HT, Stovring H, Sandbaek A. 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. Trials. 2014 Aug 29;15:341. doi: 10.1186/1745-6215-15-341.