Effect on Attendance if Including Focused Information of Spirometry in Preventive Health Checks
1 other identifier
interventional
4,496
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedApril 20, 2018
November 1, 2015
1.2 years
November 19, 2015
April 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
the percentage of participants with abnormal spirometry assessed at the preventive health
one-year recruitment
Study Arms (2)
Invitation with focused information of spirometry
EXPERIMENTALStandard invitition
ACTIVE COMPARATORInterventions
Focused information of spirometry in the invitation to the preventive health check compose the intervention in this trial.
The active comparator will receive a standard invitation to the preventive health checks. The preventive health checks in the active comparator group and the intervention group are identical.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Terminal illness as reported by the citizens general practitioner.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Randers Municipality, Denmarkcollaborator
- Central Denmark Regioncollaborator
- TRYG Foundationcollaborator
Study Sites (1)
Institute of public health, section of general practice, Aarhus University
Aarhus C, Aarhus County, 8000, Denmark
Related Publications (14)
Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.
PMID: 15485730BACKGROUNDLauritzen T, Jensen MS, Thomsen JL, Christensen B, Engberg M. Health tests and health consultations reduced cardiovascular risk without psychological strain, increased healthcare utilization or increased costs. An overview of the results from a 5-year randomized trial in primary care. The Ebeltoft Health Promotion Project (EHPP). Scand J Public Health. 2008 Aug;36(6):650-61. doi: 10.1177/1403494807090165.
PMID: 18775821BACKGROUNDHoj K, Skriver MV, Hansen AL, Christensen B, Maindal HT, Sandbaek A. Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial. BMC Public Health. 2014 Oct 10;14:1057. doi: 10.1186/1471-2458-14-1057.
PMID: 25300392BACKGROUNDVestbo J, Hurd SS, Agusti 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.
PMID: 22878278BACKGROUNDFabricius P, Lokke A, Marott JL, Vestbo J, Lange P. Prevalence of COPD in Copenhagen. Respir Med. 2011 Mar;105(3):410-7. doi: 10.1016/j.rmed.2010.09.019. Epub 2010 Oct 16.
PMID: 20952174BACKGROUNDRiegels-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.
PMID: 22315521BACKGROUNDLokke 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.
PMID: 22643016BACKGROUNDLauritzen T, Leboeuf-Yde C, Lunde IM, Nielsen KD. Ebeltoft project: baseline data from a five-year randomized, controlled, prospective health promotion study in a Danish population. Br J Gen Pract. 1995 Oct;45(399):542-7.
PMID: 7492424BACKGROUNDLauritzen 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.
PMID: 9214067BACKGROUNDMoher D, Hopewell S, Schulz KF, Montori V, Gotzsche 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.
PMID: 20346624BACKGROUNDLange P, Sondergaard J. [Early diagnosis of COPD is important and possible]. Ugeskr Laeger. 2013 Apr 29;175(18):1247-50. Danish.
PMID: 23651799BACKGROUNDMaindal 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.
PMID: 25169211BACKGROUNDOrts LM, Lokke A, Bjerregaard AL, Maindal HT, Norman K, Bech BH, Sandbaek A. The effect on participation rates of including focused spirometry information in a health check invitation: a cluster-randomised trial in Denmark. BMC Public Health. 2019 Aug 28;19(1):1183. doi: 10.1186/s12889-019-7531-5.
PMID: 31462261DERIVEDOrts LM, Lokke A, Bjerregaard AL, Maindal HT, Sandbaek A. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):571. doi: 10.1186/s13063-016-1704-7.
PMID: 27906034DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Annelli Sandbæk, Professor
Institute of public health, section of general practice, Aarhus University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 26, 2015
Study Start
November 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
April 20, 2018
Record last verified: 2015-11