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Sponsored by: |
Hillel Yaffe Medical Center |
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Information provided by: | Hillel Yaffe Medical Center |
ClinicalTrials.gov Identifier: | NCT00829348 |
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.
Condition | Intervention |
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Dyslipidemia |
Other: No intervention Behavioral: Short Message Service (SMS) |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment |
Official Title: | Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins. |
Enrollment: | 120 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Statins, counseling: No Intervention
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
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Other: No intervention
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
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Statins, Counselling, SMS: Experimental
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
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Behavioral: Short Message Service (SMS)
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hillel Yaffe medical center ( Avraham Shotan, MD ) |
Study ID Numbers: | 61-2005-CTIL |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829348 History of Changes |
Health Authority: | Israel: Ministry of Health |
Compliance Chronic Pharmacotherapy Statins |
Metabolic Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Dyslipidemias Lipid Metabolism Disorders |