DyslipidemiaNCT00829348
Short Message Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins
A study testing Short Message Service (SMS) in people with Dyslipidemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Short Message Service (SMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins.
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.
- Conditions
- Dyslipidemia
- Being tested
- No intervention, Short Message Service (SMS)
- Keywords
- Compliance, Chronic, Pharmacotherapy, Statins
- Medical subject headings
- Dyslipidemias, Patient Compliance, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group
Short Message Service (SMS)Behavioural
60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
| Study group | Role | What they receive |
|---|---|---|
| Statins, counseling | No intervention | 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group Receives: Other: No intervention |
| Statins, Counselling, SMS | Experimental | 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group Receives: Behavioral: Short Message Service (SMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve target goals
Measured: Every three months at one year period
Secondary outcomes (1)
Total cholesterol, LDL, HDL, TG
Measured: Every three months at one year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Avraham Shotan, MD, Study chair, Hillel Yaffe medical center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829348
- Sponsor's protocol ID
- 61-2005-CTIL
- Status last verified
- Dec 2009
- First submitted
- 26 Jan 2009
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
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 12355991Ostojic 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 15785218Anhoj 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 15631966Vilella 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 15020186Bos 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 15775951Kwon 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 15563964Ferrer-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 15494086Power 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 15304436Sherry 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 14696592Marquez 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 15546536Neville 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.
PubMed 12228151Bramley 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 15937529Lieu 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 9521970Obermayer 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 15495883Dyer 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Massages Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins.
- ClinicalTrials.gov ID
- NCT00829348
- Acronym / sponsor ID
- 61-2005-CTIL
- Conditions
- Dyslipidemia
- Keywords
- Compliance, Chronic, Pharmacotherapy, Statins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statins, counseling | No intervention | Other: No intervention60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group |
| Statins, Counselling, SMS | Experimental | 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group | Other | Statins, counseling |
| 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 | Behavioural | Statins, Counselling, SMS |
Primary outcome
Number of patients who achieve target goals
Time frame: Every three months at one year period
1 secondary outcome
Total cholesterol, LDL, HDL, TG
Time frame: Every three months at one year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2009.
- Background: PubMed 12355991Consoli 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.
- Background: PubMed 15785218Ostojic 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.
- Background: PubMed 15631966Anhoj 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.
- Background: PubMed 15020186Vilella 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.
- Background: PubMed 15775951Bos 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.
- Background: PubMed 15563964Kwon 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.
- Background: PubMed 15494086Ferrer-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.
- Background: PubMed 15304436Power 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.
- Background: PubMed 14696592Sherry 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.
- Background: PubMed 15546536Marquez 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.
- Background: PubMed 12228151Neville 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.
- Background: PubMed 15937529Bramley 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.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avraham Shotan, MD study chair
Hillel Yaffe medical center, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Message Service (SMS) in people with Dyslipidemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who achieve target goals (time frame: Every three months at one year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829348, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2009.