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CompletedNCT00829348Updated Dec 30, 2009

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

An interventional study of No intervention and Short Message Service (SMS) in Dyslipidemia, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-12-30.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • Compliance
  • Chronic
  • Pharmacotherapy
  • Statins
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 120 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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).
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
120 participants (actual)

Study arms

  • No intervention
    Statins, counseling

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

    Other: No intervention

  • 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)

Interventions

  • OtherNo intervention

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

  • BehavioralShort Message Service (SMS)

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

06

What researchers measure

Primary outcomes

  1. Number of patients who achieve target goals

    Time frame: Every three months at one year period

Secondary outcomes

  1. Total cholesterol, LDL, HDL, TG

    Time frame: Every three months at one year period

07

Study locations

1 site
  • Hillel Yaffe medical center
    Hadera, 38100, Israel
08

References and documents

Publications

  • Consoli SM, Bruckert E, Marcantoni JP, Clavel T. [Factors associated with the opinion of hypercholesterolemic patients on the duration of their treatment. Results of the FRACTION study]. Presse Med. 2002 Sep 7;31(28):1302-8. French. PubMed 12355991 ↗
  • 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. doi: 10.1089/tmj.2005.11.28. PubMed 15785218 ↗
  • Anhoj J, Moldrup C. Feasibility of collecting diary data from asthma patients through mobile phones and SMS (short message service): response rate analysis and focus group evaluation from a pilot study. J Med Internet Res. 2004 Dec 2;6(4):e42. doi: 10.2196/jmir.6.4.e42. PubMed 15631966 ↗
  • Vilella A, Bayas JM, Diaz MT, Guinovart C, Diez C, Simo D, Munoz A, Cerezo J. The role of mobile phones in improving vaccination rates in travelers. Prev Med. 2004 Apr;38(4):503-9. doi: 10.1016/j.ypmed.2003.12.005. PubMed 15020186 ↗
  • Bos A, Hoogstraten J, Prahl-Andersen B. Failed appointments in an orthodontic clinic. Am J Orthod Dentofacial Orthop. 2005 Mar;127(3):355-7. doi: 10.1016/j.ajodo.2004.11.014. PubMed 15775951 ↗
  • 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. doi: 10.1016/j.diabres.2003.10.028. PubMed 15563964 ↗
  • Ferrer-Roca O, Cardenas A, Diaz-Cardama A, Pulido P. Mobile phone text messaging in the management of diabetes. J Telemed Telecare. 2004;10(5):282-5. doi: 10.1258/1357633042026341. PubMed 15494086 ↗
  • 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. doi: 10.1093/deafed/enh042. PubMed 15304436 ↗
  • Sherry E, Colloridi B, Warnke PH. Short message service (SMS): a useful communication tool for surgeons. ANZ J Surg. 2002 May;72(5):369. doi: 10.1046/j.1445-2197.2002.02411.x. No abstract available. PubMed 14696592 ↗
  • Marquez Contreras E, de la Figuera von Wichmann M, Gil Guillen V, Ylla-Catala A, Figueras M, Balana 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. doi: 10.1016/s0212-6567(04)78922-2. Spanish. PubMed 15546536 ↗
  • 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. doi: 10.1136/bmj.325.7364.600/a. No abstract available. Erratum In: BMJ.2008 Apr 19;336(7649) doi:10.1136/bmj.39552.645775.AD. Tracy, A [corrected to Tracey A]. PubMed 12228151 ↗
  • Bramley D, Riddell T, Whittaker R, Corbett T, Lin RB, Wills M, Jones M, Rodgers A. Smoking cessation using mobile phone text messaging is as effective in Maori as non-Maori. N Z Med J. 2005 Jun 3;118(1216):U1494. PubMed 15937529 ↗
  • Lieu TA, Capra AM, Makol J, Black SB, Shinefield HR. Effectiveness and cost-effectiveness of letters, automated telephone messages, or both for underimmunized children in a health maintenance organization. Pediatrics. 1998 Apr;101(4):E3. doi: 10.1542/peds.101.4.e3. PubMed 9521970 ↗
  • 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. doi: 10.3200/JACH.53.2.71-78. PubMed 15495883 ↗
  • Dyer O. Patients will be reminded of appointments by text messages. BMJ. 2003 Jun 14;326(7402):1281. doi: 10.1136/bmj.326.7402.1281-a. No abstract available. PubMed 12805131 ↗
  • Lauruska V, Kubilinskas E. A system for teleconsulting, communication and distance learning for people with disabilities. J Telemed Telecare. 2002;8 Suppl 2:49-50. doi: 10.1177/1357633X020080S222. PubMed 12217133 ↗
  • Ferrer-Roca O, Franco Burbano K, Cardenas A, Pulido P, Diaz-Cardama A. Web-based diabetes control. J Telemed Telecare. 2004;10(5):277-81. doi: 10.1258/1357633042026288. PubMed 15494085 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00829348
Lead sponsor
Hillel Yaffe Medical Center
First posted
Jan 27, 2009
Start date
Aug 2006
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Dec 30, 2009

Study contacts

Avraham Shotan, MD
study chair · Hillel Yaffe medical center, Hadera, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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