NCT02615769

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 20, 2018

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

November 19, 2015

Last Update Submit

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

EXPERIMENTAL
Behavioral: focused information of spirometry in the invitation

Standard invitition

ACTIVE COMPARATOR
Behavioral: standard invitation

Interventions

Focused information of spirometry in the invitation to the preventive health check compose the intervention in this trial.

Invitation with focused information of spirometry

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.

Standard invitition

Eligibility Criteria

Age30 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Institute of public health, section of general practice, Aarhus University

Aarhus C, Aarhus County, 8000, Denmark

Location

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: 15485730BACKGROUND
  • Lauritzen 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: 18775821BACKGROUND
  • Hoj 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: 25300392BACKGROUND
  • Vestbo 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: 22878278BACKGROUND
  • Fabricius 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: 20952174BACKGROUND
  • 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.

    PMID: 22315521BACKGROUND
  • Lokke 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: 22643016BACKGROUND
  • Lauritzen 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: 7492424BACKGROUND
  • 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.

    PMID: 9214067BACKGROUND
  • Moher 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: 20346624BACKGROUND
  • Lange P, Sondergaard J. [Early diagnosis of COPD is important and possible]. Ugeskr Laeger. 2013 Apr 29;175(18):1247-50. Danish.

    PMID: 23651799BACKGROUND
  • 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.

    PMID: 25169211BACKGROUND
  • Orts 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.

  • Orts 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.

Related Links

MeSH Terms

Conditions

Patient ParticipationLung Diseases

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorRespiratory Tract Diseases

Study Officials

  • Annelli Sandbæk, Professor

    Institute of public health, section of general practice, Aarhus University

    STUDY CHAIR

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

Locations