Observational Study to Understand Patients' and Physicians' Attitudes to Statins in TurkeY (STAY)
8. januar 2014 opdateret af: AstraZeneca
In Turkey statin compliance is lower than EU countries.
(EURIKA).
We will assess the underlying causes of statin incompliance.
The investigators will build patient and physician education programs to improve compliance in TURKEY.
Our aim is to assess patients' and physicians' attitudes to statins by mean of HABIT Patient and Physician survey respectively.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Observational study to understand patients' and physicians' attitudes to Statins in TurkeY
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Kalkun
- Research Site
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Aydin, Kalkun
- Research name
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Diyarbakir, Kalkun
- Research Site
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Hatay, Kalkun
- Research Site
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Istanbul, Kalkun
- Research Site
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Izmir, Kalkun
- Research Site
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K. Maras, Kalkun
- Research Site
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Kayseri, Kalkun
- Research Site
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Malatya, Kalkun
- Research Site
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Manisa, Kalkun
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients > 18 years of age, diagnosed with hypercholesterolemia and prescribed with at least one statin irrespective of its type and/or dose.
The inclusion period will last 6 months, on which consecutive patients attending the outpatient Family Physicians or Cardiologists office will be invited to participate.
Beskrivelse
Inclusion Criteria:
- Provision of subject informed consent Female and/or male aged over 18 years,
- Diagnosis of hypercholesterolemia according to ICD-10 classification
- Receiving at least one prescription of one statin during the last 12 months and to be an outpatient.
Exclusion Criteria:
- Receiving statin at the time of admittance
- Patients unable to read and/or understand the study questionnaires
- Pregnant women,
- Patients participating in randomized clinical trials and patients included in this study once
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HABIT scores for the patients of the following questionnaire items (see description)
Tidsramme: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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HABIT scores for the physicians of the following questionnaire items (see description)
Tidsramme: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Socio-demographics terms
Tidsramme: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Clinical characteristics
Tidsramme: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Clinical characteristics (continuation)
Tidsramme: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Mujgan Ates, DR, AZ MC Turkey
- Ledende efterforsker: Ramazan Ozdemir, PROF.DR., Inonu University Faculty of Medicine, Cardiology Department
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
- Shah ND, Dunlay SM, Ting HH, Montori VM, Thomas RJ, Wagie AE, Roger VL. Long-term medication adherence after myocardial infarction: experience of a community. Am J Med. 2009 Oct;122(10):961.e7-13. doi: 10.1016/j.amjmed.2008.12.021. Epub 2009 Jun 26.
- Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000 Feb 28;160(4):459-67. doi: 10.1001/archinte.160.4.459.
- Ho PM, Magid DJ, Shetterly SM, Olson KL, Maddox TM, Peterson PN, Masoudi FA, Rumsfeld JS. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008 Apr;155(4):772-9. doi: 10.1016/j.ahj.2007.12.011.
- Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol. 2004 Aug 4;44(3):720-32. doi: 10.1016/j.jacc.2004.07.001.
- Ertas FS. [Statins with a perspective of lifelong therapy]. Turk Kardiyol Dern Ars. 2009 Mar;37 Suppl 2:29-36. Turkish.
- Tokgozoglu L, Kaya EB, Erol C, Ergene O; EUROASPIRE III Turkey Study Group. [EUROASPIRE III: a comparison between Turkey and Europe]. Turk Kardiyol Dern Ars. 2010 Apr;38(3):164-72. Turkish.
- Ford I, Murray H, Packard CJ, Shepherd J, Macfarlane PW, Cobbe SM; West of Scotland Coronary Prevention Study Group. Long-term follow-up of the West of Scotland Coronary Prevention Study. N Engl J Med. 2007 Oct 11;357(15):1477-86. doi: 10.1056/NEJMoa065994.
- Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002 Jul 24-31;288(4):455-61. doi: 10.1001/jama.288.4.455.
- Glader EL, Sjolander M, Eriksson M, Lundberg M. Persistent use of secondary preventive drugs declines rapidly during the first 2 years after stroke. Stroke. 2010 Feb;41(2):397-401. doi: 10.1161/STROKEAHA.109.566950. Epub 2010 Jan 14.
- Lardizabal JA, Deedwania PC. Benefits of statin therapy and compliance in high risk cardiovascular patients. Vasc Health Risk Manag. 2010 Oct 5;6:843-53. doi: 10.2147/VHRM.S9474.
- Yang Y, Thumula V, Pace PF, Banahan BF 3rd, Wilkin NE, Lobb WB. Predictors of medication nonadherence among patients with diabetes in Medicare Part D programs: a retrospective cohort study. Clin Ther. 2009 Oct;31(10):2178-88; discussion 2150-1. doi: 10.1016/j.clinthera.2009.10.002.
- Chan DC, Shrank WH, Cutler D, Jan S, Fischer MA, Liu J, Avorn J, Solomon D, Brookhart MA, Choudhry NK. Patient, physician, and payment predictors of statin adherence. Med Care. 2010 Mar;48(3):196-202. doi: 10.1097/MLR.0b013e3181c132ad.
- Foley KA, Vasey J, Berra K, Alexander CM, Markson LE. The Hyperlipidemia: Attitudes and Beliefs in Treatment (HABIT) survey for patients: results of a validation study. J Cardiovasc Nurs. 2005 Jan-Feb;20(1):35-42. doi: 10.1097/00005082-200501000-00008.
- Foley KA, Vasey J, Alexander CM, Markson LE. Development and validation of the hyperlipidemia: attitudes and beliefs in treatment (HABIT) survey for physicians. J Gen Intern Med. 2003 Dec;18(12):984-90. doi: 10.1111/j.1525-1497.2003.30114.x.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
19. juni 2012
Først indsendt, der opfyldte QC-kriterier
21. juni 2012
Først opslået (Skøn)
22. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-CTR-XXX-2012/1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .