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

NCT ID: NCT00829348

Last Updated: 2009-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Dyslipidemia

Keywords

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Compliance Chronic Pharmacotherapy Statins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Statins, counseling

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

Group Type NO_INTERVENTION

No intervention

Intervention Type OTHER

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

Statins, Counselling, SMS

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

Group Type EXPERIMENTAL

Short Message Service (SMS)

Intervention Type BEHAVIORAL

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

Interventions

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No intervention

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

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe medical center

Principal Investigators

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Avraham Shotan, MD

Role: STUDY_CHAIR

Hillel Yaffe medical center, Hadera, Israel

Locations

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Hillel Yaffe medical center

Hadera, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 15785218 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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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. doi: 10.1016/j.diabres.2003.10.028.

Reference Type BACKGROUND
PMID: 15563964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15494086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15304436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14696592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15546536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12228151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15937529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9521970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15495883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12805131 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 15494085 (View on PubMed)

Other Identifiers

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61-2005-CTIL

Identifier Type: -

Identifier Source: org_study_id