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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01625884
First received: June 19, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition
Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Observational Study to Understand Patients' and Physicians' Attitudes to Statins in TurkeY

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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

  • HABIT scores for the physicians 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 ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • Socio-demographics terms [ Time Frame: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period ] [ Designated as safety issue: No ]
    • Age
    • Sex
    • Smoking habits
    • Educational level
    • Professional status
    • Place of residence
    • Income level
    • Healthcare insurance level

  • Clinical characteristics [ Time Frame: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period ] [ Designated as safety issue: No ]
    • 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

  • Clinical characteristics (continuation) [ Time Frame: Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period ] [ Designated as safety issue: No ]
    • 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


Enrollment: 500
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625884

Locations
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, Turkey
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mujgan Ates, DR AZ MC Turkey
Principal Investigator: Ramazan Ozdemir, PROF.DR. Inonu University Faculty of Medicine, Cardiology Department
  More Information

Additional Information:
Publications:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01625884     History of Changes
Other Study ID Numbers: NIS-CTR-XXX-2012/1
Study First Received: June 19, 2012
Last Updated: January 8, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by AstraZeneca:
Statin
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014