Baseline data for the Extensive Lifestyle Management Intervention (ELMI) trial showed that 302 randomized patients with ischemic heart disease had well-matched risk factors and lifestyle behaviors between groups.
RCT (n=302)
Open-label
computer-generated variable block randomization
Yes
Does an extensive lifestyle management intervention reduce IHD global risk in patients with ischemic heart disease following cardiac rehabilitation?
The ELMI trial is designed to evaluate whether a 4-year case-managed lifestyle intervention can prevent the deterioration of risk factors and reduce global IHD risk in patients who have completed standard cardiac rehabilitation.
BACKGROUND: Cardiac rehabilitation programs (CRP) represent comprehensive interventions that are typically limited to four months. Following completion of CRP, it appears that risk factors and lifestyle behaviours may deteriorate. The Extensive Lifestyle Management Intervention (ELMI) Following Cardiac Rehabilitation trial will investigate the benefits of a randomized intervention to prevent these adverse changes. METHODS: Patients with ischemic heart disease (IHD) were randomized following a standard CRP to the ELMI or to usual care. The ELMI program is a case-managed intervention aimed at individualizing risk factor and lifestyle management based on current treatment guidelines. The program consists of cardiac rehabilitation sessions, telephone follow-up and risk factor and lifestyle counselling sessions. Health professionals work with participants using behavioural counselling and communications with participants' family physicians. Usual care participants return to their family physicians' care, and come to the study clinic only to undergo annual outcomes assessment. The primary outcome is change in IHD global risk after four years. Secondary outcomes include combined cardiovascular events, health care utilization, lifestyle adherence, quality of life and risk factors. RESULTS: Over 28 months, 302 men and women were randomized. This represented 29% of the total population screened. The average age of study participants is 64 years, 18% are women, 53% have had a previous myocardial infarction, 73% have undergone previous revascularization and 20% have diabetes mellitus. Ischemic heart disease risk factors for the entire cohort improved significantly after subjects had gone through previous CRPs. Baseline risk factors, lifestyle behaviours and medications were similar between the groups. CONCLUSIONS: This study population is representative of patients completing a standard CRP. Results of the ELMI trial will provide valuable information for the future design of CRPs.
Lear et al. (Tue,) conducted a rct in Ischemic heart disease (n=302). Extensive Lifestyle Management Intervention (ELMI) vs. Usual care was evaluated on Absolute change in global risk for ischemic heart disease from baseline to year four. Baseline data for the Extensive Lifestyle Management Intervention (ELMI) trial showed that 302 randomized patients with ischemic heart disease had well-matched risk factors and lifestyle behaviors between groups.
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