Awareness and Adherence to Statin and Antiplatelet Therapy
- Conditions
- Atherosclerotic heart disease of native coronary artery,
- Registration Number
- CTRI/2023/10/059075
- Lead Sponsor
- Seth GS Medical College KEM Hospital Diamond Jubilee Society Trust
- Brief Summary
India has one of the highest burdens of cardiovascular disease (CVD) worldwide. Statins are effective lipid-lowering drugs and prescribed widely for both primary prevention and secondary prevention of atherosclerotic cardiovascular diseases such as coronary heart diseases, stroke and peripheral artery diseases .Lack of knowledge plays an important role in adherence to therapy. Evidence suggests that inadequate knowledge about cholesterol or statin therapy is prevalent among statin users.Very few studies related to Drug Awareness and adherence to stain therapy has been done India.
Primary objective of the study is to study the awareness regarding statins in patients. Secondary objective is to evaluate adherence to statin and antiplatelet therapy in patients and to find out awareness about statins side effects in patients and to evaluate control of hyperlipidaemia in patients receiving statins.Study site will be Cardiology OPD at tertiary care hospital.
Patients on statin therapy will be screened according to the inclusion and exclusion criteria. Consent from those participants will be obtained who fulfil the eligibility criteria. Prior to consenting patient will be given a patient information sheet to know the details of the study. If the patient is unable to read, then it will be read out by the investigator or impartial witness, In simple language. Once the consent has been obtained, ICD will be signed, retained by the principal investigator and a copy of ICD will be given to patient. Each patient will be assigned a unique study identification number. After taking consent from patient, patients’ prescription will be scrutinized. Patients demographic details including age, sex, occupation, education and social economic status by Kuppuswamy classification will be noted. Duration of statin therapy of the patient will be documented. And changes in the medication will be recorded from previous prescription carried by the patient and comorbid conditions will also be noted. Details of the prescription current visit will be noted down which will include the drug name, dose, schedule, duration, route of administration. Patients’ lab investigation report will be scrutinized. Patients’ lipid profile and blood glucose profile will be noted down. Patient will be administered drug awareness and adherence questionnaire. Answers to the questions will be noted in a 15-20 min interview of the patient. Drug awareness questionnaire for patients will consist of total 15 questions. Drug awareness is defined as understanding about the medications provided by physician with respect to name of medication, indications, frequency, dosage, side effects. The questions have responses graded on a Likert scale with 2 options (Yes, No). Selected questions have sub questions and their responses will be recorded in descriptive form. Drug adherence questionnaire will consist of 2 sections one for adherence to statin therapy and one for adherence to antiplatelet therapy. Each section will have 6 questions. The questions have responses graded on a Likert scale with 2 options (Yes, No)
Primary Variable for the study will be Drug awareness Score . Secondary Variables will be as follows:
1. Duration of statin treatment 2. Mean participant score 3. % Of participants who responded Yes or No to each item and sub-questions 4. Corelation analysis with patient and disease factors, drug awareness score.
Sample size of 300 patients will be considered. Patients attending Cardiology OPD, meeting the inclusion/ exclusion criteria during the study period will be enrolled.
For statistical analysis ,
Continuous variables would be presented as mean ± standard deviation (SD) .
Categorical data (e.g., Gender, education status, socioeconomic status) will be expressed as percentage.
Drug awareness questionnaire and Adherence questionnaire with variables of prescription pattern will be analysed using descriptive statistics .
Correlation analysis for Drug awareness score and Adverse Drug Reaction Capture table with scales.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 300
- Male or female patients with age 18-75 years, who have been started on statins within a period of previous 6 months to 5 years .
- Patients who are planned for angioplasty or have undergone angioplasty in the past one month of data collection who have routine blood investigation reports.
- Newly diagnosed and treatment naive patients 2.
- Patients not willing to give informed consent.
- Patients admitted in Cardiology IPD and emergency department.
- Women with known pregnancy or desire to conceive within a year.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method awareness about statins in patient receiving statin 12 months therapy 12 months
- Secondary Outcome Measures
Name Time Method adherence to statin therapy and evaluate control of hyperlipidaemia in patients on statin therapy
Trial Locations
- Locations (1)
SETH GS MEDICAL COLLEGE &KEM HOSPITAL
🇮🇳Mumbai, MAHARASHTRA, India
SETH GS MEDICAL COLLEGE &KEM HOSPITAL🇮🇳Mumbai, MAHARASHTRA, IndiaDr PADMAJA MARATHEPrincipal investigator9619466099pam2671@gmail.com