Short Message Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins

Study Overview
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Brief Summary
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The objective of the study is to determine whether short text massages could be used successfully as a compliance aid and improve clinical outcomes in long term lipid lowering therapy.

Detailed Description
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Indication: Patients discharged from the Intensive Cardiac Care Unit or the Internal Medicine Department following acute coronary syndrome (ACS) events such as unstable angina or acute myocardial infarction who will be prescribed a statin for the first time for preventing further coronary episodes. Drug(s) and Dose/Regimen: Regular or aggressive Simvastatin therapy (dose will be adjusted according to LDL and Total Cholesterol levels). Treatment period 6 months. Objectives: To determine whether using SMS technology can improve compliance and hence clinical outcomes in patients with long-term lipid lowering therapy. Primary outcome: number of patients who achieve target LDL goals. Secondary outcomes: reductions of total cholesterol, LDL, LDL/HDL and CRP; increase of HDL; Readmissions due to ACS. Study Background/Rationale/Purpose: Long-term lipid lowering therapy is the cornerstone of preventing recurrent cardiac events in patients that have experienced such episodes. Numerous studies have demonstrated the efficacy of statins in the treatment of hyperlipidemia and reduction of total mortality, vascular mortality and coronary adverse events1. One of the main concerns affecting the success of long-term chronic drug treatments is patients' compliance and adherence to the prescribed regimen. Till date there is no gold standard system that will assure complete patient compliance. It has been suggested to explore the possibility of using short messages service (SMS) technology to improve patients' compliance 2-18. Such technology may be effective in targeting this problem; however, no controlled trials have been conducted to validate this method in long-term lipid lowering treatments. Furthermore, Israel is one of the leading countries in terms of expansion of the mobile phone services market, making SMS a feasible and effective form of communication with patients.

Official Title
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Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins.

Conditions
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Dyslipidemia

Intervention / Treatment
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* Other: No intervention
* Behavioral: Short Message Service (SMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients discharged from the Intensive Cardiac Care Unit or the Internal Medicine Department following ACS who will be prescribed a statin for the first time for preventing further coronary episodes. Patients in the ages of 18-80. Patients who own mobile phone and are familiar with SMS technology and are able to read Hebrew text. Exclusion Criteria: Contra indication to study medication: active liver disease or elevated liver enzymes; hypersensitivity to Simvastatin; pregnancy and lactation. Developed Myopathy/Rhabodmyalisis during study period. Developed increase in transaminases greater than 3 times the upper limit of normal. Current lipid lowering treatment (statins or other).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Statins, counseling<br>60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group | Other: No intervention<br>* 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group<br>|
| Experimental: Statins, Counselling, SMS<br>60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group | Behavioral: Short Message Service (SMS)<br>* 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who achieve target goals |  | Every three months at one year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol, LDL, HDL, TG |  | Every three months at one year period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compliance, Chronic, Pharmacotherapy, Statins