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

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT01625884
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Study Start: 2012-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HABIT scores for the patients of the following questionnaire items (see description)	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	* 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)	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	* 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

Name	Time	Method
Socio-demographics terms	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	* Age; * Sex; * Smoking habits; * Educational level; * Professional status; * Place of residence; * Income level; * Healthcare insurance level
Clinical characteristics	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	* 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)	Participants will be questioned at visit one, visits will take part during 25 weeks of expected study period	* 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

Trial Locations

Locations (2)

Research Site; 🇹🇷 Manisa, Turkey

Research name; 🇹🇷 Aydin, Turkey