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HypercholesterolemiaSTAYNCT01625884

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

An observational study of Hypercholesterolemia, run by AstraZeneca at 10 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hypercholesterolemia
How many people
500 participants
Where
10 sitesTurkey (Türkiye)
Study dates
Oct 2012to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Turkey (Türkiye)10 sites

  • Research Site

    Ankara

  • Research name

    Aydin

  • Research Site

    Diyarbakır

  • Research Site

    Hatay

  • Research Site

    Istanbul

  • Research Site

    Izmir

  • Research Site

    K. Maras

  • Research Site

    Kayseri

  • Research Site

    Malatya

  • Research Site

    Manisa

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

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

Keywords
Statin, Hypercholesterolemia
Medical subject headings
Hypercholesterolemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period

  2. 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

    Measured: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period

Secondary outcomes (3)

  1. Socio-demographics terms

    • Age
    • Sex
    • Smoking habits
    • Educational level
    • Professional status
    • Place of residence
    • Income level
    • Healthcare insurance level

    Measured: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period

  2. 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

    Measured: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period

  3. 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

    Measured: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625884
Sponsor's protocol ID
NIS-CTR-XXX-2012/1
Acronym
STAY
Status last verified
Jan 2014
First submitted
19 Jun 2012
Last updated
9 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11368702

  • 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.

    PubMed 15358046

  • 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.

    PubMed 10695686

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

    PubMed 19404048

  • 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.

    PubMed 20675993

  • 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.

    PubMed 17928595

  • 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.

    PubMed 12132975

  • 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.

    PubMed 18371492

  • 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.

    PubMed 19560749

  • 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.

    PubMed 20075360

  • 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.

    PubMed 20957130

  • 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.

    PubMed 19922889

  • 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.

    PubMed 19890219

  • 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.

    PubMed 15632811

  • 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.

    PubMed 14687256

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia, run by AstraZeneca at 10 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HABIT scores for the patients of the following questionnaire items (see description) (time frame: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625884, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.

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