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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
No intervention
Short Message Service (SMS)
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dyslipidemia focused on measuring Compliance, Chronic, Pharmacotherapy, Statins

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hillel Yaffe medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Statins, counseling

Statins, Counselling, SMS

Arm Description

60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group

60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group

Outcomes

Primary Outcome Measures

Number of patients who achieve target goals

Secondary Outcome Measures

Total cholesterol, LDL, HDL, TG

Full Information

First Posted
January 26, 2009
Last Updated
December 29, 2009
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00829348
Brief Title
Short Message Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins
Official Title
Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Compliance, Chronic, Pharmacotherapy, Statins

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statins, counseling
Arm Type
No Intervention
Arm Description
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
Arm Title
Statins, Counselling, SMS
Arm Type
Experimental
Arm Description
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
Intervention Type
Behavioral
Intervention Name(s)
Short Message Service (SMS)
Intervention Description
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
Primary Outcome Measure Information:
Title
Number of patients who achieve target goals
Time Frame
Every three months at one year period
Secondary Outcome Measure Information:
Title
Total cholesterol, LDL, HDL, TG
Time Frame
Every three months at one year period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avraham Shotan, MD
Organizational Affiliation
Hillel Yaffe medical center, Hadera, Israel
Official's Role
Study Chair
Facility Information:
Facility Name
Hillel Yaffe medical center
City
Hadera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

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

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