Observational Study to Understand Patients' and Physicians' Attitudes to Statins in TurkeY

Hypercholesterolemia Clinical Trial

— STAY  

Official title:

Observational Study to Understand Patients' and Physicians' Attitudes to Statins in TurkeY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625884
• Other study ID #: NIS-CTR-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: January 8, 2014
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

Observational study to understand patients' and physicians' attitudes to Statins in TurkeY

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypercholesterolemia

Locations

Country	Name	City	State
Turkey	Research Site	Ankara
Turkey	Research name	Aydin
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Hatay
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	K. Maras
Turkey	Research Site	Kayseri
Turkey	Research Site	Malatya
Turkey	Research Site	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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. — View Citation

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. — View Citation

Ertas FS. [Statins with a perspective of lifelong therapy]. Turk Kardiyol Dern Ars. 2009 Mar;37 Suppl 2:29-36. Review. Turkish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Glader EL, Sjölander 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Tokgözoglu 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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HABIT scores for the patients of the following questionnaire items (see description)	Total score; Effectiveness of cholesterol-lowering medications; Association of high doses with adverse experiences; Risk of high cholesterol; Severity of high cholesterol; Frustration with the process of care; Difficulty in following advice / making changes; Doctor-patient communication; Communication about cholesterol	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	No
Primary	HABIT scores for the physicians of the following questionnaire items (see description)	Total score; Effectiveness of statins; Patients view titration negatively; Risk associated with higher doses; Close enough to goal; Urgency of getting to goal; Utility of diet and exercise; Time and resources to counsel patients; Physician self-efficacy in treating patients to goal	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	No
Secondary	Socio-demographics terms	Age; Sex; Smoking habits; Educational level; Professional status; Place of residence; Income level; Healthcare insurance level	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	No
Secondary	Clinical characteristics	Date of diagnosis; Current disease status: Physical examination results (vital signs and anthropometric measurements); Cardiovascular risk factors; Relevant co-morbidities; Cholesterol levels (LDL-C) at inclusion (if available); Number of hospitalizations during the last 12 months; Duration of statin use in the past year	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	No
Secondary	Clinical characteristics (continuation)	List of poor compliance (discontinuation) causes in the past one year; Treatment discontinuation (statins), reported causes; Time to discontinuation of statin therapy (in early stage/medium term/long term); Change in lipid levels and other laboratory findings (i.e. hepatic and muscle enzymes) during statin use (before, during and after discontinuation of statin therapy); List of alternative drug and non-drug therapies received after discontinuation of statin and number (%) of patients who switched to those alternative therapies; Concomitant treatments	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	No

External Links

•   NIS-CTR-XXX-2012/1 Study Report Synopsis