Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial

Abstract

BackgroundEarly detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance.The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks.Methods/designThis randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to –49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015–2016, 4356 citizens aged 30–49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check.Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups.DiscussionThe results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective.Trial registrationClinicalTrials.gov: NCT02615769. Registered on 25 November 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1704-7) contains supplementary material, which is available to authorized users.

The effect on participation rates of including focused spirometry information in a health check invitation: a cluster-randomised trial in Denmark

“…The study is registered at ClinicalTrials.gov (NCT02615769), and the trial protocol has been published [11]. The study conforms to the Consolidated Standards Of Reporting Trials (CONSORT), including the extension for non-pharmacological interventions and cluster trials [12, 13].…”

“…Each participant received a personal recommendation based on the individual risk profile and current health status. The web-based questionnaire consisted of questions regarding smoking, alcohol use, lung symptoms, physical activity, mental health and self-rated health [11]. The clinical examination took place in the community health centre in Randers and included blood analyses, blood pressure, height, weight, cardiorespiratory fitness score and spirometry.…”

“…Trained healthcare professionals performed the clinical examinations. The setting, the questionnaire and the clinical examination have been described in detail elsewhere [11, 14].…”

“…Before the invitation was sent, a focus group tested the material for comprehensibility and content, and few revisions were made accordingly. Further details on routine procedures, intervention and information material are available in the Additional file 1 and in the trial protocol [11].…”

“…An independent data manager performed the randomisation on 7 October 2015 before the inclusion period of the study. The randomisation was based on the postal address, which was obtained from the Danish Civil Registration System [11, 19]. Cluster randomisation by household was chosen to minimise the potential contamination between participants living together because motivation to participate in the health check might affect the entire household.…”