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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01260207
Other study ID # R-07-391
Secondary ID
Status Terminated
Phase Phase 3
First received December 13, 2010
Last updated August 25, 2017
Start date January 2010
Est. completion date December 15, 2014

Study information

Verified date March 2017
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 654
Est. completion date December 15, 2014
Est. primary completion date December 15, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients discharged from LHSC with ACS (acute myocardial infarction, STEMI, NSTEMI or unstable angina)

- Patients who have a land line telephone service at home

- Patients who speak English

Exclusion Criteria:

- Patients discharged to a care facility or transferred to another health care institution

- Patients who cannot provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
IVR group
Patients in this arm will receive IVR follow-up telephone calls at 1,3,6,9 and 12 months post-discharge consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Upon completion of the IVR follow-up, all patients will be called by a member of the clinical research staff and asked to complete a follow-up survey.

Locations

Country Name City State
Canada London Health Sciences Centre London Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance with BPGs 1 Year
Secondary Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction 1 Year
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