DyslipidemiaEPRINANCT02380911
Statins at the Primary Care Level
A study testing Educational Intervention in people with Dyslipidemia, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
Trial summary
Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 10 sitesArgentina
- Study dates
- Apr 2015to Apr 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization.
- Moderate-High CVD risk according to the WHO charts adapted by the National MoH (estimated 10-year CVD risk ≥ 20%)
- LDL-C level ≥ 190 mg/dL
- Type 2 diabetes in patients between 40 and 75 years of age
Who cannot join
- Patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent.
- End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol or drugs abuse.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Argentina10 sites
Centro de Atención Primaria de la Salud N°11
Corrientes, 1034
Centro de Atención Primaria de la Salud Dr. Balbastro
Corrientes
Centro de Atención Primaria de la Salud N°13
Corrientes
Centro de Atención Primaria "Jardín Residencial"
La Rioja
Centro de Atención Primaria de la Salud "Faldeo del Velazco"
La Rioja
Centro de Atención Primaria de la Salud "Dr. Favaloro"
Puerto Madryn, Chubut Province
Centro de Atención Primaria de la Salud "Ruca Calil"
Puerto Madryn, Chubut Province
Centro de Atención Primaria de la Salud "Malvinas Argentinas"
Rawson, Chubut Province
Hospital San Luis del Palmar
San Luis del Palmar, Corrientes Province
Centro de Atención Primaria de la Salud "Etcheparre"
Trelew, Chubut Province
About this study
Official title: An Educational Intervention to Improve Effectiveness in the Detection, Treatment and Control of Patients With High Cardiovascular Risk in Low-resource Settings in Argentina: Rationale and Study Design of a Cluster Randomized Controlled Trial.
Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.
- Conditions
- Dyslipidemia
- Being tested
- Educational Intervention
- Keywords
- Dyslipidemia, Global cardiovascular risk, Statins, Educational interventions
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Physicians belonging to the PCC randomized to the intervention group receive a 3-component intervention: education workshop, Educational Outreach Visits and a mHealth application uploaded to their smartphones.
In addition, 2 intervention support tools are used at the intervention clinics:
- A web-based platform that is tailored to send SMS messages for lifestyle modification, and prompts and reminders for clinic appointments are used to improve medication adherence for patients.
- On-site training to pharmacist assistants at the first EOV is given by physician trainers focused on counseling to improve medication adherence among patients initiating statin therapy and at each patient visit to the clinic to refill drug prescriptions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a multifaceted educational intervention targeting physicians and pharmacist assistants to improve detection, treatment and control of hypercholesterolemia among uninsured patients with moderate-high cardiovascular risk in Argentina. Receives: Other: Educational Intervention |
| No Intervention Group | No intervention | This group will continue with the usual care. Irrespective of the assignment of the clinic to the intervention or control group, all physicians from participating PCCs have received previous training on global cardiovascular risk management, given by the Ministry of Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol Level
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.
Measured: 1 year
Secondary outcomes (5)
Global Cardiovascular Risk
Net change in 10-year-CVD Framingham risk score before and after the implementation of the program.
Measured: 1 year
Clinical practice guidelines compliance
Proportion of patients with high CVD risk who are on statins, and are receiving an appropriate dose according to the CPG.
Measured: 1 year
Cholesterol reduction
Proportion of patients with moderate-high CVD risk who have reduced 30% and 50% of their LDL-C, respectively.
Measured: 1 year
Treatment compliance
Level of treatment adherence evaluated through questionnaire.
Measured: 1 year
Costs of the intervention
Cost-effectiveness of the intervention program.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adolfo Rubinstein, MD, MSc, PhD, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380911
- Sponsor's protocol ID
- 11526941
- Acronym
- EPRINA
- Status last verified
- Aug 2017
- First submitted
- 26 Jan 2015
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gulayin PE, Lozada A, Beratarrechea A, Gutierrez L, Poggio R, Chaparro RM, Santero M, Masson W, Rubinstein A, Irazola V. An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina. Am J Prev Med. 2019 Jul;57(1):95-105. doi: 10.1016/j.amepre.2019.02.018. Epub 2019 May 23.
PubMed 31128958Gulayin P, Irazola V, Lozada A, Chaparro M, Santero M, Gutierrez L, Poggio R, Beratarrechea A, Rubinstein A. Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial. BMJ Open. 2017 Jan 31;7(1):e014420. doi: 10.1136/bmjopen-2016-014420.
PubMed 28143840
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention to Improve Effectiveness in the Detection, Treatment and Control of Patients With High Cardiovascular Risk in Low-resource Settings in Argentina: Rationale and Study Design of a Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02380911
- Acronym / sponsor ID
- EPRINA / 11526941
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, Global cardiovascular risk, Statins, Educational interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Mar 2015 (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.
Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Educational InterventionThe intervention group will receive a multifaceted educational intervention targeting physicians and pharmacist assistants to improve detection, treatment and control of hypercholesterolemia among uninsured patients with moderate-high cardiovascular risk in Argentina. |
| No Intervention Group | No intervention | –This group will continue with the usual care. Irrespective of the assignment of the clinic to the intervention or control group, all physicians from participating PCCs have received previous training on global cardiovascular risk management, given by the Ministry of Health |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization.
- Moderate-High CVD risk according to the WHO charts adapted by the National MoH (estimated 10-year CVD risk ≥ 20%)
- LDL-C level ≥ 190 mg/dL
- Type 2 diabetes in patients between 40 and 75 years of age
Key exclusion criteria (2 listed)
- Patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent.
- End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol or drugs abuse.
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 |
|---|---|---|
| Educational InterventionPhysicians belonging to the PCC randomized to the intervention group receive a 3-component intervention: education workshop, Educational Outreach Visits and a mHealth application uploaded to their smartphones. In addition, 2 intervention support tools are used at the intervention clinics: 1. A web-based platform that is tailored to send SMS messages for lifestyle modification, and prompts and reminders for clinic appointments are used to improve medication adherence for patients. 2. On-site training to pharmacist assistants at the first EOV is given by physician trainers focused on counseling to improve medication adherence among patients initiating statin therapy and at each patient visit to the clinic to refill drug prescriptions. | Other | Intervention Group |
Primary outcome
Cholesterol Level
Time frame: 1 year
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.
5 secondary outcomes
Global Cardiovascular Risk
Time frame: 1 year
Clinical practice guidelines compliance
Time frame: 1 year
Cholesterol reduction
Time frame: 1 year
Treatment compliance
Time frame: 1 year
Costs of the intervention
Time frame: 1 year
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 16 Aug 2017.
- Derived from this study: PubMed 31128958Gulayin PE, Lozada A, Beratarrechea A, Gutierrez L, Poggio R, Chaparro RM, Santero M, Masson W, Rubinstein A, Irazola V. An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina. Am J Prev Med. 2019 Jul;57(1):95-105. doi: 10.1016/j.amepre.2019.02.018. Epub 2019 May 23.
- Derived from this study: PubMed 28143840Gulayin P, Irazola V, Lozada A, Chaparro M, Santero M, Gutierrez L, Poggio R, Beratarrechea A, Rubinstein A. Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial. BMJ Open. 2017 Jan 31;7(1):e014420. doi: 10.1136/bmjopen-2016-014420.
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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.
Adolfo Rubinstein, MD, MSc, PhD principal investigator
Institute for Clinical Effectiveness and Health Policy
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Dyslipidemia, run by Institute for Clinical Effectiveness and Health Policy at 10 sites in Argentina.
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 4 inclusion and 2 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina. 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?
Cholesterol Level (time frame: 1 year). 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 NCT02380911, which also lists 2 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 16 Aug 2017.