Lung Diseases Clinical Trial
Official title:
Effect on Attendance if Including Focused Information of Spirometry in Preventive Health Checks - a Randomized Controlled Trial in Primary Health Care
Verified date | November 2015 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate if focused information of spirometry in the invitation to preventive health checks will increase the attendance compared with a standard invitation to preventive health checks.
Status | Completed |
Enrollment | 4496 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Citizens in the municipality of Randers per 01.01.2012 - Randomized for the fourth group of five groups in total to be invited for a preventive health check as part of the health promotion program, Check your health prevention program, conducted in the years 2012 to 2017. Exclusion Criteria: - Terminal illness as reported by the citizens general practitioner. |
Country | Name | City | State |
---|---|---|---|
Denmark | Institute of public health, section of general practice, Aarhus University | Aarhus C | Aarhus County |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Central Denmark Region, Randers Municipality, Denmark, TRYG Foundation |
Denmark,
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Lauritzen T, Nielsen KD, Leboeuf-Yde C, Lunde IM. [The health project Ebeltoft: health check ups and discussions in general practice. Basic data from a 5-year, prospective, randomized, controlled population study]. Ugeskr Laeger. 1997 Jun 16;159(25):3940-6. Danish. — View Citation
Løkke A, Ulrik CS, Dahl R, Plauborg L, Dollerup J, Kristiansen LC, Cording PH, Dehlendorff C; TOP GOLD study-group. Detection of previously undiagnosed cases of COPD in a high-risk population identified in general practice. COPD. 2012 Aug;9(5):458-65. doi: 10.3109/15412555.2012.685118. Epub 2012 May 29. — View Citation
Maindal HT, Støvring 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. — View Citation
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum in: J Clin Epidemiol. 2012 Mar;65(3):351. — View Citation
Riegels-Jakobsen T, Skouboe M, Dollerup J, Andersen CB, Staal LB, Jakobsen RB, Poulsen PB. Municipality screening of citizens with suspicion of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2012;7:35-41. doi: 10.2147/COPD.S27314. Epub 2012 Feb 1. — View Citation
Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of participants attending the health check compared between the groups | Primary outcome measure is effect of the focused information in the invitations on attendance. | one-year recruitment | |
Secondary | the percentage of participants with abnormal spirometry assessed at the preventive health | Secondary outcome is the percentage of participants with abnormal spirometry assessed at the preventive health check. | one-year recruitment |
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