Acute Coronary SyndromeNCT01151800
Using Automated Calls To Improve Compliance With Acute Coronary Syndrome Best Practice Guidelines
A study testing Using IVR to maintain ACS patients on best practice guidelines in people with Acute Coronary Syndrome and Medication Adherence, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Medication Adherence
- What is being tested?
- Using IVR to maintain ACS patients on best practice guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,608 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to May 2010
- 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
- Patients discharged from the UOHI with ACS (acute myocardial infarction, STEMI or NSTEMI)
- Patients who have a land line telephone service at home
- Patients who speak English or French
Who cannot join
- Patients discharged to a care facility or transferred to another health care institution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Interactive Voice Response To Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).
The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.
Read the detailed description
Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.
- Conditions
- Acute Coronary Syndrome, Medication Adherence
- Being tested
- Using IVR to maintain ACS patients on best practice guidelines
- Keywords
- ACS, Interactive Voice Response Technology, Best Practice Guidelines, Health Care Utilization, Outcome Assessment
- Medical subject headings
- Acute Coronary Syndrome, Medication Adherence, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using IVR to maintain ACS patients on best practice guidelinesOther
| Study group | Role | What they receive |
|---|---|---|
| IVR group | Experimental | Not described Receives: Other: Using IVR to maintain ACS patients on best practice guidelines |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with BPGs
Measured: 1 year
Secondary outcomes (1)
Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
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 posted28 Jun 2010 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Enrolment
- 1,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- The Change Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151800
- Sponsor's protocol ID
- UOHI 2006-128
- Status last verified
- Jun 2010
- First submitted
- 25 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Interactive Voice Response To Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
- ClinicalTrials.gov ID
- NCT01151800
- Acronym / sponsor ID
- UOHI 2006-128
- Conditions
- Acute Coronary Syndrome, Medication Adherence
- Keywords
- ACS, Interactive Voice Response Technology, Best Practice Guidelines, Health Care Utilization, Outcome Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,608 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- The Change Foundation
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Jun 2010 (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 purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).
The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.
Detailed description
Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVR group | Experimental | Other: Using IVR to maintain ACS patients on best practice guidelines |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients discharged from the UOHI with ACS (acute myocardial infarction, STEMI or NSTEMI)
- Patients who have a land line telephone service at home
- Patients who speak English or French
Key exclusion criteria (1 listed)
- Patients discharged to a care facility or transferred to another health care institution
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 |
|---|---|---|
| Using IVR to maintain ACS patients on best practice guidelines | Other | IVR group |
Primary outcome
Compliance with BPGs
Time frame: 1 year
1 secondary outcome
Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
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 28 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using IVR to maintain ACS patients on best practice guidelines in people with Acute Coronary Syndrome and Medication Adherence, run by Ottawa Heart Institute Research 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 3 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 28 Jun 2010. 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?
Compliance with BPGs (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2010.