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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829348
• Other study ID #: 61-2005-CTIL
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: December 29, 2009
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: December 2009
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
Israel	Hillel Yaffe medical center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (17)

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Kwon HS, Cho JH, Kim HS, Lee JH, Song BR, Oh JA, Han JH, Kim HS, Cha BY, Lee KW, Son HY, Kang SK, Lee WC, Yoon KH. Development of web-based diabetic patient management system using short message service (SMS). Diabetes Res Clin Pract. 2004 Dec;66 Suppl 1:S133-7. — View Citation

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Márquez Contreras E, de la Figuera von Wichmann M, Gil Guillén V, Ylla-Catalá A, Figueras M, Balaña M, Naval J. [Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert)]. Aten Primaria. 2004 Nov 15;34(8):399-405. Spanish. — View Citation

Neville R, Greene A, McLeod J, Tracey A, Surie J. Mobile phone text messaging can help young people manage asthma. BMJ. 2002 Sep 14;325(7364):600. Erratum in: BMJ.2008 Apr 19;336(7649) doi:10.1136/bmj.39552.645775.AD. Tracy, A [corrected to Tracey A].. — View Citation

Obermayer JL, Riley WT, Asif O, Jean-Mary J. College smoking-cessation using cell phone text messaging. J Am Coll Health. 2004 Sep-Oct;53(2):71-8. — View Citation

Ostojic V, Cvoriscec B, Ostojic SB, Reznikoff D, Stipic-Markovic A, Tudjman Z. Improving asthma control through telemedicine: a study of short-message service. Telemed J E Health. 2005 Feb;11(1):28-35. — View Citation

Power MR, Power D. Everyone here speaks TXT: deaf people using SMS in Australia and the rest of the world. J Deaf Stud Deaf Educ. 2004 Summer;9(3):333-43. — View Citation

Sherry E, Colloridi B, Warnke PH. Short message service (SMS): a useful communication tool for surgeons. ANZ J Surg. 2002 May;72(5):369. — View Citation

Vilella A, Bayas JM, Diaz MT, Guinovart C, Diez C, Simó D, Muñoz A, Cerezo J. The role of mobile phones in improving vaccination rates in travelers. Prev Med. 2004 Apr;38(4):503-9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who achieve target goals		Every three months at one year period	No
Secondary	Total cholesterol, LDL, HDL, TG		Every three months at one year period	No