Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
841 participants
INTERVENTIONAL
2010-05-31
2012-09-30
Brief Summary
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Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath (dyspnoea) which causes decreased mobility and restrictions in physical, psychological and social functioning. Patients commonly attribute this symptom to their age, and simply adjust their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative impact on the quality of life and are associated with frequent hospital admissions. Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in primary care. Establishing a diagnosis early in the course of the disease is useful because both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic triage-strategy followed bij direct treatment would be of great importance to asses and treat heart failure and COPD in elderly patient with shortness of breath.
Objective of the study:
Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the difference in prevalence of unrecognised COPD and heart failure between those who underwent the diagnostic triage compared to those who received care as usual. Quantify the effect of the diagnostic triage plus the additionally treatment changes on functionality and quality of life after 6 months compared to those who received care as usual. Quantify the cost-effectiveness of the diagnostic triage strategy compared to care as usual
Study design:
A clustered randomized diagnostic (follow-up) study
Study population:
First, pre-selection of patients aged over 65 years from 50 general practices is based on frailty. Frailty is based on the next criteria: use 5 or more different types of medical drugs chronically in the last year and/or have 3 or more chronic or vitality treating diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be done from the electronic medical files of the general practices. These elderly will receive the MRC questionnaire of dyspnoea and three additional questions related tot exercise intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to participate, except those with established heart failure and COPD.
Study parameters/outcome of the study:
Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart failure and COPD between both groups.
Differences in functionality and quality of life after 6 months between both groups. Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Index group
Patients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing.
Index group
Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing
Control
Participants receive care as usual.
No interventions assigned to this group
Interventions
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Index group
Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year
* must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires)
Exclusion Criteria
* patients unable or unwilling to sign informed consent
65 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
UMC Utrecht
OTHER
Responsible Party
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F.H. Rutten
Dr
Principal Investigators
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Frans H Rutten, Dr.
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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General practionners " de Grebbe"
Rhenen, , Netherlands
Countries
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References
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Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
Mulrow CD, Lucey CR, Farnett LE. Discriminating causes of dyspnea through clinical examination. J Gen Intern Med. 1993 Jul;8(7):383-92. doi: 10.1007/BF02600079. No abstract available.
Landahl S, Steen B, Svanborg A. Dyspnea in 70-year-old people. Acta Med Scand. 1980;207(3):225-30. doi: 10.1111/j.0954-6820.1980.tb09710.x.
Hogg K, Swedberg K, McMurray J. Heart failure with preserved left ventricular systolic function; epidemiology, clinical characteristics, and prognosis. J Am Coll Cardiol. 2004 Feb 4;43(3):317-27. doi: 10.1016/j.jacc.2003.07.046.
Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.
Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Levy S, Linde C, Lopez-Sendon JL, Nieminen MS, Pierard L, Remme WJ; Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Jun;26(11):1115-40. doi: 10.1093/eurheartj/ehi204. Epub 2005 May 18. No abstract available.
Rutten FH, Cramer MJ, Lammers JW, Grobbee DE, Hoes AW. Heart failure and chronic obstructive pulmonary disease: An ignored combination? Eur J Heart Fail. 2006 Nov;8(7):706-11. doi: 10.1016/j.ejheart.2006.01.010. Epub 2006 Mar 13.
Remes J, Miettinen H, Reunanen A, Pyorala K. Validity of clinical diagnosis of heart failure in primary health care. Eur Heart J. 1991 Mar;12(3):315-21. doi: 10.1093/oxfordjournals.eurheartj.a059896.
Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity and underdiagnosis of COPD in the primary care setting. Thorax. 2008 May;63(5):402-7. doi: 10.1136/thx.2007.085456. Epub 2008 Jan 30.
Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23.
Geijer RM, Sachs AP, Hoes AW, Salome PL, Lammers JW, Verheij TJ. Prevalence of undetected persistent airflow obstruction in male smokers 40-65 years old. Fam Pract. 2005 Oct;22(5):485-9. doi: 10.1093/fampra/cmi049. Epub 2005 Jun 17.
Rutten FH, Moons KG, Cramer MJ, Grobbee DE, Zuithoff NP, Lammers JW, Hoes AW. Recognising heart failure in elderly patients with stable chronic obstructive pulmonary disease in primary care: cross sectional diagnostic study. BMJ. 2005 Dec 10;331(7529):1379. doi: 10.1136/bmj.38664.661181.55. Epub 2005 Dec 1.
McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. doi: 10.1097/00005650-199303000-00006.
Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998 Nov;51(11):1055-68. doi: 10.1016/s0895-4356(98)00097-3.
Brooks RG, Jendteg S, Lindgren B, Persson U, Bjork S. EuroQol: health-related quality of life measurement. Results of the Swedish questionnaire exercise. Health Policy. 1991 Jun;18(1):37-48. doi: 10.1016/0168-8510(91)90142-k.
Weinberger M, Samsa GP, Schmader K, Greenberg SM, Carr DB, Wildman DS. Comparing proxy and patients' perceptions of patients' functional status: results from an outpatient geriatric clinic. J Am Geriatr Soc. 1992 Jun;40(6):585-8. doi: 10.1111/j.1532-5415.1992.tb02107.x.
Weber M, Hamm C. Role of B-type natriuretic peptide (BNP) and NT-proBNP in clinical routine. Heart. 2006 Jun;92(6):843-9. doi: 10.1136/hrt.2005.071233. No abstract available.
Wright SP, Doughty RN, Pearl A, Gamble GD, Whalley GA, Walsh HJ, Gordon G, Bagg W, Oxenham H, Yandle T, Richards M, Sharpe N. Plasma amino-terminal pro-brain natriuretic peptide and accuracy of heart-failure diagnosis in primary care: a randomized, controlled trial. J Am Coll Cardiol. 2003 Nov 19;42(10):1793-800. doi: 10.1016/j.jacc.2003.05.011.
Doust JA, Glasziou PP, Pietrzak E, Dobson AJ. A systematic review of the diagnostic accuracy of natriuretic peptides for heart failure. Arch Intern Med. 2004 Oct 11;164(18):1978-84. doi: 10.1001/archinte.164.18.1978.
Davie AP, Francis CM, Love MP, Caruana L, Starkey IR, Shaw TR, Sutherland GR, McMurray JJ. Value of the electrocardiogram in identifying heart failure due to left ventricular systolic dysfunction. BMJ. 1996 Jan 27;312(7025):222. doi: 10.1136/bmj.312.7025.222. No abstract available.
van Mourik Y, Rutten FH, Bertens LCM, Cramer MJM, Lammers JJ, Gohar A, Reitsma JB, Moons KGM, Hoes AW. Clinical research study implementation of case-finding strategies for heart failure and chronic obstructive pulmonary disease in the elderly with reduced exercise tolerance or dyspnea: A cluster randomized trial. Am Heart J. 2020 Feb;220:73-81. doi: 10.1016/j.ahj.2019.08.021. Epub 2019 Sep 1.
Bertens LC, Reitsma JB, van Mourik Y, Lammers JW, Moons KG, Hoes AW, Rutten FH. COPD detected with screening: impact on patient management and prognosis. Eur Respir J. 2014 Dec;44(6):1571-8. doi: 10.1183/09031936.00074614. Epub 2014 Jun 12.
van Mourik Y, Moons KG, Bertens LC, Reitsma JB, Hoes AW, Rutten FH. Triage of frail elderly with reduced exercise tolerance in primary care (TREE). A clustered randomized diagnostic study. BMC Public Health. 2012 May 28;12:385. doi: 10.1186/1471-2458-12-385.
Related Links
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study protocol
Other Identifiers
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NL30278.041.10
Identifier Type: OTHER
Identifier Source: secondary_id
NTR2336
Identifier Type: REGISTRY
Identifier Source: secondary_id
311040302
Identifier Type: -
Identifier Source: org_study_id
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