AzTrials
AzTrials

Acute Myocardial InfarctionDERLA-STEMINCT01325116

Delayed Educational Reminders in Acute Myocardial Infarction (MI)

A study testing Educational Reminder in people with Acute Myocardial Infarction and STEMI, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction, STEMI
What is being tested?
Educational Reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
852 participants
Where
1 siteCanada
Study dates
Sep 2011to Mar 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admitted with STEMI to a hospital in LHIN IV, coronary angiogram with and without PCI at Hamilton General Hospital during hospital admission

Who cannot join

  • Non-english speaking

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton Health Sciences-General Site, Heart Investigation Unit

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI): Cluster-randomized Controlled Trial

ST segment elevation myocardial infarction (STEMI) is a common presentation of heart attack constituting approximately 30% of all cases. Clinical guidelines around the world support the prolonged use of secondary preventative medications including aspirin, clopidogrel, statin, beta-blocker and angiotensin blockers with the highest recommendations. While in-hospital and discharge prescription rates are excellent, adherence to these essential life-saving medications is far less than ideal, even a few months following hospital discharge. The investigators plan to capitalize on the existing structure of the SMART-AMI project already underway in LHIN IV to undertake a randomized controlled trial evaluating a reminder sent on behalf of the interventional cardiologists, delivered by mail, at 1, 2, 5, 8, and 11-months post-discharge, reviewing the evidence for life-saving cardiac medications and urging long-term adherence to secondary preventative cardiac medications. This will be sent to the family physician and the patient, using audience-appropriate language. If the DERLA-STEMI project is accepted by physicians and patients, found to be both feasible and effective, then this simple and low-cost intervention will be studied in all patients with an abnormal coronary angiogram.

Being tested
Educational Reminder
Keywords
STEMI, Medication Adherence, Quality Improvement
Medical subject headings
ST Elevation Myocardial Infarction, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational ReminderBehavioural

    Personalized letters sent via post to the patient and their family physician at one, five, eight, and eleven months after their angiogram, sent on behalf of the interventional cardiologist. The patient letter provides a review of the role of each of the cardiac medications and urges long-term adherence. The language in the patient letter is simplified to a grade 6 level; this letter was tested for understanding and acceptability amongst a series of Cardiology patients.At the same time, close examination of data from Ontario indicated large stepwise declines in adherence at 30 and 60 days post-STEMI. To address this, patients will be provided an additional postcard type reminder two months post-STEMI.

Study groups in NCT01325116
Study groupRoleWhat they receive
ControlActive comparatorUsual post-STEMI care
Receives: Behavioral: Educational Reminder
InterventionExperimentalRecurrent, personalized, educational reminders sent via post on behalf of the interventional cardiologist to the patient and their family physician urging long-term adherence to secondary prevention medications post-STEMI. A copy of the letter will be provided to the patient to take to their pharmacist.
Receives: Behavioral: Educational Reminder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac Medication Use

    Proportion of patients who report taking all cardiac medication classes, measured three and twelve months post-STEMI. Specifically, we will assess whether patients are taking a statin, beta-blocker, angiotensin modifier (ACE or ARB), and aspirin at twelve months, and whether they are taking these plus a secondary antiplatelet (clopidogrel, prasugrel, or ticagrelor) at three months.

    Measured: 3 and 12 months

Secondary outcomes (6)

  1. Other Evidence-based Cardiac Medication Use

    Proportion of patients who report actively taking aspirin, clopidogrel, statin, beta-blocker, and/or angiotensin blocker

    Measured: 3 and 12 months

  2. Statin Dose

    Proportion of patients taking high dose statins at three and twelve months

    Measured: 3 and 12 months

  3. Medication Side-effects

    Proportion of patients who report stopping medications due to side effects at three and twelve months

    Measured: 3 and 12 months

  4. Discussion with Family physician/specialist

    Proportion of patients who state that they had a discussion with their FP regarding the benefits of certain medications to prevent future heart attacks or that focused on medication compliance since their heart attack.

    Measured: 3 and 12 months

  5. Use of medication combinations

    The proportion of patients using 1 of 5, 2 of 5, 3 of 5, 4 of 5, or 5 of 5 medications at three and twelve months.

    Measured: 3 and 12 months

  6. Adherence

    Proportion of patients with a perfect Morisky Green Levine Test for cardiac medication compliance at three and twelve months.

    Measured: 3 and 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2012
  4. Study completionMar 2013

Resources

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
None (open label)
Enrolment
852 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325116
Sponsor's protocol ID
MAC-DS-03-2011
Acronym
DERLA-STEMI
Status last verified
Aug 2018
First submitted
28 Mar 2011
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Schwalm JD, Ivers NM, Natarajan MK, Taljaard M, Rao-Melacini P, Witteman HO, Zwarenstein M, Grimshaw JM. Cluster randomized controlled trial of Delayed Educational Reminders for Long-term Medication Adherence in ST-Elevation Myocardial Infarction (DERLA-STEMI). Am Heart J. 2015 Nov;170(5):903-13. doi: 10.1016/j.ahj.2015.08.014. Epub 2015 Aug 20.

    PubMed 26542498

  • Ivers NM, Schwalm JD, Grimshaw JM, Witteman H, Taljaard M, Zwarenstein M, Natarajan MK. Delayed educational reminders for long-term medication adherence in ST-elevation myocardial infarction (DERLA-STEMI): protocol for a pragmatic, cluster-randomized controlled trial. Implement Sci. 2012 Jun 9;7:54. doi: 10.1186/1748-5908-7-54.

    PubMed 22682691

Questions about this trial

What is this clinical trial studying?

A study testing Educational Reminder in people with Acute Myocardial Infarction and STEMI, run by Hamilton Health Sciences Corporation at 1 site in Canada.

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 1 inclusion and 1 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 31 Aug 2018. 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 Canada. 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?

Cardiac Medication Use (time frame: 3 and 12 months). 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 NCT01325116, 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 31 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in