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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00829348
Collaborator
(none)
120
1
2
35
3.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention
  • Behavioral: Short Message Service (SMS)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Health Services Research
Official Title:
Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins.
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Statins, counseling

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

Other: No intervention
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group

Experimental: Statins, Counselling, SMS

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients who achieve target goals [Every three months at one year period]

Secondary Outcome Measures

  1. Total cholesterol, LDL, HDL, TG [Every three months at one year period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hillel Yaffe medical center Hadera Israel 38100

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

  • Study Chair: Avraham Shotan, MD, Hillel Yaffe medical center, Hadera, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00829348
Other Study ID Numbers:
  • 61-2005-CTIL
First Posted:
Jan 27, 2009
Last Update Posted:
Dec 30, 2009
Last Verified:
Dec 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2009