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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ankara, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
- 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
- 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 outcomes

Socio-demographics terms

Time frame: 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

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: STAY

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 22, 2012
Registry last updated: Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed