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A randomized controlled trial of an extensive lifestyle management intervention (ELMI) following cardiac… Lear, Scott A; Ignaszewski, Andrew; Linden, Wolfgang; Brozic, Anka; Kiess, Marla; Spinelli, John J; Pritchard, P H; Frohlich, Jiri J Nov 12, 2002

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ralCurrent Controlled Trials in ssBioMed CentCardiovascular MedicineOpen AcceCurrent Controlled Trials in Cardiovascular Medicine 2002, 3 xResearch articleA randomized controlled trial of an extensive lifestyle management intervention (ELMI) following cardiac rehabilitation: study design and baseline dataScott A Lear*1,2, Andrew Ignaszewski2, Wolfgang Linden3, Anka Brozic4, Marla Kiess5, John J Spinelli6, P Haydn Pritchard7 and Jiri J Frohlich2,7Address: 1School of Kinesiology, Simon Fraser University, Burnaby, Canada, 2Healthy Heart Program, St. Paul's Hospital, University of British Columbia, Vancouver, Canada, 3Department of Psychology, University of British Columbia, Vancouver, Canada, 4Healthy Heart Program, Vancouver General Hospital, Vancouver, Canada, 5Department of Medicine and Radiology, University of British Columbia, Vancouver, Canada, 6Cancer Control Research Program, British Columbia Cancer Agency, Vancouver, Canada and 7Dept. of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, CanadaE-mail: Scott A Lear* - slear@providencehealth.bc.ca; Andrew Ignaszewski - aignaszewski@providencehealth.bc.ca; Wolfgang Linden - wlinden@vanhosp.bc.ca; Anka Brozic - abrozic@vanhosp.bc.ca; Marla Kiess - mkiess@rovidencehealth.bc.ca; John J Spinelli - jspinelli@bccancer.bc.ca; P Haydn Pritchard - haydn@unixg.ubc.ca; Jiri J Frohlich - jifr@unixg.ubc.ca*Corresponding authorKeywords: Cardiac rehabilitation, risk factor management, lifestyle management, compli-ance, ischemic heart disease, randomized trialsAbstractBackground: Cardiac rehabilitation programs (CRP) represent comprehensive interventions thatare typically limited to four months. Following completion of CRP, it appears that risk factors andlifestyle behaviours may deteriorate. The Extensive Lifestyle Management Intervention (ELMI)Following Cardiac Rehabilitation trial will investigate the benefits of a randomized intervention toprevent these adverse changes.Methods: Patients with ischemic heart disease (IHD) were randomized following a standard CRPto the ELMI or to usual care. The ELMI program is a case-managed intervention aimed atindividualizing risk factor and lifestyle management based on current treatment guidelines. Theprogram consists of cardiac rehabilitation sessions, telephone follow-up and risk factor and lifestylecounselling sessions. Health professionals work with participants using behavioural counselling andcommunications with participants' family physicians. Usual care participants return to their familyphysicians' care, and come to the study clinic only to undergo annual outcomes assessment. Theprimary outcome is change in IHD global risk after four years. Secondary outcomes includecombined cardiovascular events, health care utilization, lifestyle adherence, quality of life and riskfactors.Results: Over 28 months, 302 men and women were randomized. This represented 29% of thetotal 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 improvedsignificantly after subjects had gone through previous CRPs. Baseline risk factors, lifestylePublished: 12 November 2002Current Controlled Trials in Cardiovascular Medicine 2002, 3:9Received: 5 July 2002Accepted: 12 November 2002This article is available from: http://cvm.controlled-trials.com/content/3/1/9© 2002 Lear et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.Page 1 of 14(page number not for citation purposes)behaviours and medications were similar between the groups.Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9Conclusions: 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.BackgroundCurrent cardiac rehabilitation programs (CRPs) employpharmacological management, smoking cessation, nutri-tion, and exercise and behavioural counselling to effec-tively manage ischemic heart disease (IHD) risk factorsand to promote favourable lifestyle changes. Previous re-search has demonstrated that CRPs can reduce morbidityand mortality as well as cost of care. [1–5] Studies such asthe Stanford Coronary Risk Intervention Project (SCRIP)and the Lifestyle Heart Trial have demonstrated that long-term lifestyle and risk factor management results in regres-sion of atherosclerosis and reduction in cardiovascularevents.[3,4] Despite this finding, many North Americanprograms are of only 3 to 4 months duration, due to budg-etary and resource constraints, in addition to insurancecoverage limitations. The Multi-fit trial tried to addressthis issue by conducting a post-MI nurse case-managed in-tervention consisting of counselling sessions and tele-phone follow-up that take place immediately followingpatients' cardiac events. The program, however, was notoverwhelmingly successful in demonstrating long-temcomprehensive effectiveness.[6] Therefore, current CRPsface the daunting task of teaching life-long risk factor andlifestyle management within a short time frame.Lifestyle adherence is difficult to achieve. Based on one re-port, less than one third of women were exercising the rec-ommended three times per week within one year ofcompleting a CRP.[7] Corresponding worsening of riskfactors following completion of a CRP has also been de-scribed (body mass index [BMI], total cholesterol [TC],LDL-C and triglycerides [TG] deteriorated in the years fol-lowing a CRP, with some risk factors reported to be worsethan the pre-CRP values.[8,9]At the time of the current study's development, no previ-ous reports had investigated a CRP follow-up interven-tion. We therefore conducted our own pilot study toinvestigate lifestyle adherence and risk factors for sixmonths following a CRP.[10] Thirty-six men and womenwere randomized to either a comprehensive lifestyle andrisk factor intervention or to usual care. After a six-monthintervention of six cardiac rehabilitation exercise sessionsand two telephone follow-up calls, we reported significantdecreases in TC and LDL-C in the intervention group only.These findings provided the impetus for undertaking thecurrent Extensive Lifestyle Management Intervention (EL-randomized to the four-year ELMI program following astandard CRP will decrease their global risk for IHD com-pared to a similar patient cohort undergoing usual care.To assess global risk, we will use and individually analyzetwo independent global risk scores: the Framingham(FRA) and the Procam risk scores, which reflect modifia-ble risk factors such as total cholesterol (TC), HDL-choles-terol (HDL-C), blood pressure (BP) and smoking.[11,12]MethodsRecruitment and randomizationMen and women from two identical, hospital-based CRPswere screened for the study inclusion and exclusion crite-ria (Table 1). Those patients meeting the study criteriawere asked to provide informed consent at the time oftheir exit CRP assessment (approved by the University ofBritish Columbia and the St. Paul's Hospital Ethics Com-mittees). The study criteria were designed so that the ma-jority of those individuals participating in cardiacrehabilitation would be eligible for the study. Patientswith IHD and other cardiovascular co-morbidities (i.e.,heart failure, atrial fibrillation, pacemaker, exercise-in-duced angina, etc.) were included in the study as long asthe investigators believed that these co-morbidities wouldnot interfere with full participation. Those patients whosephysical conditioning was severely compromised werenot discharged from the preceding CRP and, therefore,were not considered for the study. Consenting partici-pants underwent a baseline lifestyle and risk factor assess-ment (exercise stress test, leisure time physical activity[LTPA], diet, quality of life, smoking status, blood pres-sure (BP), lipids, blood sugar, BMI, waist circumference(WC) and medication assessment).The randomization was balanced for age (<63 or ≥ 63years), gender and adjustments in lipid-lowering medica-tion (part of the initial CRP protocol) at the time of re-cruitment (prior to randomization). Random groupassignment was conducted by a blinded research associateusing computer-generated variable block randomization.Participants were randomized to either the ELMI or UsualCare (UC) groups, as depicted in Figure 1. Due to the na-ture of the study, participants were not blinded to theirgroup assignment.Usual care groupParticipants randomized to the UC group were informedthat they would be contacted once per year to schedulePage 2 of 14(page number not for citation purposes)MI), a four-year study of 302 men and women with IHD.We hypothesize that patients with IHD who have beentheir annual outcome assessment visits. No other contactis initiated with the UC participants throughout the study.Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9After each outcome assessment, UC participants are in-formed of their results and of the desired targets for thespecific risk factors. A copy of the lab results is sent to theUC participants' family physicians. Usual Care partici-pants are instructed to direct any further questions to theirfamily physician.Extensive lifestyle management intervention groupParticipants randomized to the ELMI group were contact-ed by the case manager and scheduled for their first CRPexercise sessions. A copy of the Treatment Algorithmsused in the intervention was mailed to their family physi-cians for information purposes only (Figure 2). The ELMIis a case-managed intervention designed so that each par-ticipant receives some form of contact every month duringthe first year of intervention and every other month in thefollowing three years (Figure 1). This will result in greaterexposure to health care services than usual care and willallow us to evaluate whether a new model of health serv-ices delivery yields additional health benefits compared tousual care practices. The first year of the ELMI consists ofsix CRP exercise sessions over the first three months, sixtelephone follow-ups and three lifestyle and risk factorcounselling sessions. Thereafter, ELMI participants arescheduled for lifestyle and risk factor counselling sessionsevery six months, interspersed with telephone follow-upsat two-month intervals for three years. These modes ofcontact were chosen based on those used successfully inprevious studies [3,4,6] as well as in our pilot study.[10]The ELMI program employs the principles of the Transthe-oretical Model of Change[13] and the Social CognitiveTheory.[14] During the CRP exercise sessions as well asduring telephone follow-up calls and lifestyle and risk fac-tor counselling sessions, each participant's stage of changeis assessed prior to appropriate stage-based counselling.Participants are counselled on the positives of changing ormaintaining a desired behaviour and are advised aboutthe use of individual goal setting, based on readiness toThe six cardiac rehabilitation exercise sessions (once perweek for four weeks and once per month for two months)are monitored by the case manager and by an exerciseleader. Each session consists of a warm up, a medicallyprescribed target heart rate aerobic exercise, and a cooldown period (approximately 75 minutes). During thesesessions, participants are counselled and given guidanceon how to establish a home-based exercise program. Eachparticipant receives an ELMI Participant Manual at the on-set of the exercise sessions. The manual contains a log-book for exercise, dietary and medication information toaid in lifestyle adherence and a timetable for scheduled in-tervention contacts.Upon entry to the ELMI and at every lifestyle and risk fac-tor counselling session (a total of ten), participants receivean ELMI Lifestyle and Risk Factor Report (Figure 3), de-signed to educate and empower ELMI participants to as-sume a greater role in their health care. The Reportsummarizes the participants' current lifestyle and risk fac-tor profiles, their previous profile, current goals, and idealrisk factor and lifestyle targets. The Report is given to par-ticipants by the case manager, who explains it in detailand stresses the importance of managing each risk factorand lifestyle behaviour. On the reverse side of the Report,goals, recommendations and motivational comments aredocumented. A copy of the Report is forwarded to eachparticipant's family physician, and, when applicable, tothe cardiologist.The telephone follow-up calls adhere to a formatted out-line to 1) identify any new symptoms or change in symp-toms, 2) follow-up on goal progress and 3) assess andcounsel on exercise, diet, medications, smoking cessationand diabetes management, where applicable. This formatis similar to that used successfully in our previous pilotstudy.[10] The case manager conducting the telephonefollow-up reviews the last contact with the participant (ei-ther a previous follow-up call or an assessment and coun-Table 1: Study inclusion and exclusion criteria.Inclusion Criteria Exclusion Criteria• Patients with IHD who have completed a four month CRP.• Inability to give informed consent.• Men and women >18 years of age. • Patients who have difficulty understanding the English language.• No moving plans or extended trips. • Participation in other research trials.• Provide informed consent. • Patients currently waiting for a surgical intervention.• Patients with any other medical condition that would make survival for the duration of the study unlikely, interfere with optimal participation or produce a significant risk to the patient.Page 3 of 14(page number not for citation purposes)change, personal experience and environment. selling visit) and the Lifestyle and Risk Factor Report. Atthis time, any previously set goals are discussed, and newCurrent Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9Figure 1First YearSix cardiac rehabilitation sessionsSix telephone follow-upsThree lifestyle & risk factor counselling sessionsMonth 12Lifestyle & risk factor outcome assessmentSecond YearSix telephone follow-upsThree lifestyle & risk factor counselling sessionsMonth 24Lifestyle & risk factor outcome assessmentMonth 48Final outcome assessmentMonth 36Lifestyle & risk factor outcome assessmentFourth YearSix telephone follow-upsThree lifestyle & risk factor counselling sessionsThird YearSix telephone follow-upsThree lifestyle & risk factor counselling sessionsMonth 12Lifestyle & risk factor outcome assessmentMonth 24Lifestyle & risk factor outcome assessmentMonth 36Lifestyle & risk factor outcome assessmentMonth 48Final outcome assessmentUsual CareGroupLifestyle ManagementIntervention GroupRecruitment andrandomizationCompletion of cardiacRehabilitation programPage 4 of 14(page number not for citation purposes)Diagrammatic outline of the study.Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9Figure 2Activity ManagementEnergy Expended from Activity Action> 2000 kcal per week Maintain monitoring of activity and assessment of program adherence.< 2000 kcal per week Refer to Exercise Specialist for assessment and counselling.Dietary ManagementDietary Profile ActionMeet requirements of Step One diet. Maintain monitori ng of diet and assessment of program adherence.Do not meet requirements of Step One diet. Refer to dietitian for assessment and counselling.Weight ManagementBody Mass Index Action20-25 kg/m2 Maintain monitoring of obesity and assessment of program adherence.25-30 kg/m2 Refer to appropriate health professional for assessment and counselling.> 30 kg/m2 1. Refer to appropriate health professional for assessment and counselling.2. Letter to family physician reporting values and recommendation on action.Lipid ManagementSerum Lipoprotein Profile ActionLDL-C ≤ 2.6 mmol/LTG ≤ 2.0 mmol/LHDL- C ≥ 0.9 mmol/LMaintain monitoring of lipid profile and assessment of program adherence.LDL-C > 2.6 mmol/LTG > 2.0 mmol/LHDL- C <0.9 mmol/L1. Referred to appropriate health professional for reinforcement of lifestyle measures.2. Adjustment of lipid medications in consultation with family physician.Diabetes ManagementMetabolic Level ActionNo previous diagnosis of diabetes mellitus and optimal levels (fasting glucose 4 to 7 mmol/l and Hb A1c < 110% normal).Maintain monitoring of glucose and Hb A1c and assessment of program adherence.Previous diagnosis of diabetes mellitus and optimal levels (fasting glucose 4 to 7 mmol/l and Hb A1c < 110% normal).Maintain monitoring of fasting glucose and Hb A1c and assessment of program adherence.Suboptimal levels (fasting glucose 7 to 10 mmol/l and/or Hb A1c 110 to 140% normal).1. Referred to appropriate health professional for reinforcement of lifestyle measures.2. Appropriate initiation of oral medications in consultation with family physician.Compromised levels (fasting glucose > 10 mmol/l and/or Hb A1c >140% normal).1. Appropriate initiation of oral medications in consultation with family physician.2. Appropriate initiation of insulin in consultation with family physician.Blood Pressure ManagementBlood Pressure Treatment< 120/80 mmHg Maintain monitoring of blood pressure and assessment of program adherence.120/80 to 140/90 mmHg Self-help guide book instructing on importance of hypertension and exercise, dietary and drug adherence.> 140/90 mmHg 1. Self-help guide book instructing on importance of hypertension and exercise, dietary and drug adherence.2. Adjustment of anti-hypertensive medications in consultation with family physician.Smoking Cessation ManagementSmoking Status ActionNon-smoker Assess smoking status.Cessation > 6 months Maintain monitoring of smoking and assessment of program adherence.Cessation < 6 months Stage-matched self-help material.Relapse/current smoker 1. Stage-matched self-help material.2. Letter to family physician reporting smoking status and recommendation on action.Page 5 of 14(page number not for citation purposes)Lifestyle and risk factor treatment algorithms utilized during the ELMI lifestyle and risk factor counselling sessions.Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9goals are developed, if required. If the participant is una-vailable, a message is left. Up to three unanswered mes-sages are made before marking the telephone follow-up asa missed event. For those participants who do not have ameans of receiving a message, the call is not counted aspart of the possible three calls. Returned messages to thecase manager are also not counted in the three possiblecalls.The ELMI lifestyle and risk factor counselling sessions areconducted by the case manager a total of nine times perparticipant over the four-year intervention. Prior to thesesessions, participants are asked to complete the LTPA andthe 3-Day Food Record questionnaires and to undergo afasting blood draw (lipid profile, glucose and HbA1c if di-abetic). The sessions consist of assessment of BP, weight,WC, symptoms, medications and medication compliance.Month 6, 12, 24, 36 and 48 assessments also include agraded exercise stress test. The case manager reviews thenew Lifestyle and Risk Factor Report, provides lifestyleand risk factor counselling as appropriate, and imple-ments the ELMI Treatment Algorithms (Figure 2). Addi-tional counselling from a dietitian, exercise specialist orsmoking cessation nurse is determined from the Treat-ment Algorithms.The Treatment Algorithms for the ELMI, derived from cur-rent guidelines and expert consensus [15–19], are aimedat bridging the gap between current guidelines and currentpractices.[20] For weight, diabetes, lipid and BP manage-ment, the last category of the Treatment Algorithms dic-tates that the family physician be contacted by letterregarding recommendations for intervention. These rec-ommendations are authorized following consultation be-tween the case manager and the program cardiologist (thecardiologist does not meet with the participant). Once theprogram cardiologist has been consulted and the letter ofrecommendation mailed, participants are asked to contacttheir family physicians. This process allows the ELMI towork within the framework of the health care system, rec-ognizing the family physician as being the primary careprovider. A copy of the letter is kept in the participant'schart and reviewed during the next participant contact.Staff trainingThe case manager and health care professionals takingpart in the ELMI (dieticians, exercise specialists, nurses,etc.) were from the St. Paul's Hospital Healthy Heart Pro-gram CRP. All have had several years' previous experience.In addition, all staff had previously undergone formaltraining in counselling techniques and the stages ofchange. A trained research coordinator is responsible forconducting the annual outcomes assessment for all partic-OutcomesThe primary outcome is the absolute change in global riskfor IHD from baseline to year four between the Usual Careand ELMI groups. Global IHD risk assessment was select-ed because it is considered to be superior to any single life-style behaviour or IHD risk factor, given that it reflects themulti-factorial nature of IHD.[21,22] Global risk is deter-mined by using two independent global risk scores: 1) theFramingham (FRA) risk score (a sum of categorical pointsbased on age, gender, TC, HDL-C, BP, presence of diabetesand smoking status)[11] and 2) the Procam risk score (aregression equation based on age, gender, TC, HDL-C, BP,presence of diabetes, smoking status, previous family his-tory and presence of angina).[12] We have chosen to usetwo risk scores, since no one single score was felt to be su-perior to another for secondary prevention; however,these two scores will be analyzed and interpreted separate-ly.While the FRA and Procam risk scores were developed topredict future risk of disease, their use as an outcomemeasure does not rely on the accuracy to predict eventsbut as an instrument for assessing change in global risk.Prior to their use in this study, minor modifications weremade to the risk scores, to ease interpretation of changesin risk. These modifications will not affect how each indi-vidual risk factor contributes to the final score (i.e., agewill change equally for all participants; therefore, this hasbeen held constant). For the FRA risk score, age is heldconstant, results of variables falling above or below thehighest or lowest point categories for each variable are giv-en the score of the closest category, ex-smokers <12months are treated as non-smokers, and those withoutpreviously diagnosed diabetes but with glucose >7.8mmol/L are scored as diabetics. (This latter cut point wasused to define individuals with diabetes in the originalFramingham cohort.) For the Procam risk score, age isheld constant, family history is recorded at baseline andcarried through to follow-up unchanged, and participantswithout previously diagnosed diabetes but with glucose>6.7 mmol/L were scored as diabetics. (This latter valuewas used to define individuals with diabetes in the origi-nal Procam cohort.)A number of secondary outcomes will be captured to re-flect the multi-factorial nature of the intervention. Theseinclude combined cardiovascular events (myocardial inf-arction, revascularization procedures, hospital admis-sions of a cardiovascular nature), health care utilization,cost comparison analysis, lifestyle adherence (physical ac-tivity, exercise capacity, diet composition, smoking sta-tus), quality of life measures (stress, illness intrusiveness,self-efficacy), anthropometric measures (body mass in-Page 6 of 14(page number not for citation purposes)ipants. dex, waist circumference), IHD risk factors (lipids, fasting Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9Figure 3Lifestyle and Risk Factor Report developed at baseline and during the ten lifestyle and risk factor counselling sessions.Page 7 of 14(page number not for citation purposes)Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9glucose, blood pressure) and percent participants treatedto target.Assessment methodsCardiovascular events and health care utilization, identi-fied through documentation of medical records, will belinked to the provincial Ministry of Health database. Life-style variables are captured through questionnaires, whichwill be distributed to participants via mail three to fourweeks prior to their next scheduled outcomes assessment.Participants will be asked to complete the questionnairesat home and to give them to the research coordinator,who will review them to ensure that they have been fullycompleted.Physical activity adherence is determined by the 4-weekmodified Minnesota LTPA questionnaire.[23] Exercise ca-pacity, assessed by a symptom-limited treadmill exercisestress test with continuous 12-lead ECG monitoring, is re-ported as the maximal metabolic equivalents (METs) at-tained during the test. This method allows for the captureof ischemia and silent ischemia, based on ECG changes.Dietary adherence will be determined from a 3-Day FoodRecord [24] and will be analyzed using Nutritionist IVDiet Analysis software by First Data Bank. Average percentdaily kilocalories (kcal) are recorded for protein, carbohy-drates, total fat, saturated fat and unsaturated fat. Qualityof life is assessed by the Perceived Stress Scale [25] and theIllness Intrusive Rating[26], both of which use Likert scor-ing. Self-efficacy is reported as both a general score and anexercise-specific self-efficacy score that is based on Likertscoring. The general self-efficacy questionnaire assesses anindividual's perception of his/her ability to successfullyachieve various health-related behaviours (i.e., diet, exer-cise, medications, etc.). The exercise-specific self-efficacyquestionnaire assesses an individual's perception of his/her ability to successfully participate in structured exercisein the presence of various potential barriers such as in-clement weather, social occasions, family, etc.Body mass index is calculated from weight in kg dividedby height in m squared. Waist circumference is measureddirectly over the skin (to the nearest 0.1 cm) at the pointof maximal narrowing of the trunk as viewed from the an-terior position, with the participant standing upright fol-lowing a normal expiration.[27] A manualsphygmomanometer is used to determine blood pressure(mmHg), which is recorded as the average of two meas-ures taken two minutes apart after five minutes of seatedrest. Smoking status is determined by self-report. SerumTC, HDL-C, TG and glucose are assessed using standardmethodology.[28] LDL-C is calculated using the Fried-wald Equation (LDL-C = TC - HDL-C - TG/2.22).[29] TheStatistical power considerationsAt the time of the study's design, we were unable to projectrisk score variability (i.e., standard deviation) in this co-hort over the selected follow-up period, since no datawere available. We anticipated that 10% of participantswould be lost to follow-up (consistent with follow-up fre-quencies in other long-term trials [3,31]), leaving 90% ofparticipants available for assessment of the primary out-come. Reasons for being lost to follow-up include death,leaving the geographical area without a forwarding ad-dress and refusal to participate (either through direct con-tact or by not responding to repeated contact attempts).Importantly, lack of compliance is not a reason for with-drawal from the study. With a sample size of 135 peoplein each group, we will be able to detect 0.342 of a standarddeviation of the change between the two groups at a pow-er of 80% (α = 0.05, two sided, 0.363 of a standard devi-ation at a power of 90%). Based on data published fromthe SCRIP study, we will be able to detect differences inthe mean change of three main contributors to the prima-ry outcome and individual secondary outcomes as fol-lows: TC of 0.28 mmol/L, HDL-C of 0.08 mmol/L, andsystolic BP of 3.8 mmHg.[3] Therefore, after increasingthe number randomized to account for the 10% lost tofollow-up, a sample size of 300 participants was deter-mined a priori, resulting in 150 participants being ran-domly assigned to each study group.Data on 'lost to follow-up' participants will be analyzed toelucidate any relevant characteristics that may differ fromthe remainder of the study group. Every effort will bemade to obtain final data on the primary outcome regard-less of the extent of study participation to that point. Alldata for the primary and secondary outcomes will be ana-lyzed using an intent-to-treat analysis such that partici-pants will remain in their randomly assigned groups atfinal analysis, regardless of actual participation withinthat group.Statistical analysesBaseline characteristics of the ELMI and UC groups (age,gender, presence of concurrent disease, diagnosis, lifestylebehaviours and IHD risk factors and changes to these fac-tors as a result of the prior CRP) were compared usingPearson Chi-square tests for categorical factors and inde-pendent samples t-test for continuous factors. Changes inIHD risk factors and lifestyle behaviours as a result of theinitial CRP were analyzed for the entire cohort using apaired samples t-test. Change in smoking status as a resultof the CRP was assessed by the McNemar Chi-square test.Differences in the primary outcome between the ELMIand UC groups will be compared by an independent sam-Page 8 of 14(page number not for citation purposes)presence of angina is determined through patient inter-view, based on standard criteria.[30]ples t-test. The two global risk scores will be analyzed andreported separately. The secondary outcome of combinedCurrent Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9cardiovascular events will be described using a Kaplan-Meier survival plot. Other secondary outcomes that arecontinuous variables (health care utilization, IHD lifestyleand risk factors) will be assessed by independent samplest-tests. Changes in categorical factors (smoking status andtreat to target) will be assessed by the McNemar Chi-square test. Fulfillment of the ELMI program and use ofmedications will be presented as percentages and qualita-tive data. While not powered to draw conclusions for sub-group analyses, women and participants with diabeteswill be analyzed for the purpose of hypothesis generationusing non-parametric tests: the Mann-Whitney U test forindependent samples and the Wilcoxon test for pairedsamples.Data are reported as means ± standard deviations. All sta-tistical analyses were performed using the SPSS 10.0.07statistical package for Microsoft Windows. The signifi-cance level for all tests was set at 0.05 and all t-tests aretwo-tailed.ResultsBetween January of 1998 and May of 2000, a total of 302men and women who met the study criteria were recruitedpatients exiting the CRP met the study inclusion/exclu-sion criteria. Reasons for eligible men and women refus-ing to provide consent included: not interested, conflict inschedule with proposed intervention (i.e., occupation),possible moving plans/uncertain of future plans, time inthe CRP significantly extended due to medical reasons,and failure to be in contact after receiving the consentform. Of those eligible, approximately 49% provided in-formed consent and were randomized. Therefore, this co-hort represents 29% of the entire population of patientswho completed the two CRPs during the period of activerecruitment. Those patients who were eligible but refusedconsent (n = 320) were no different from those that con-sented with respect to age, 63.5 ± 10.4 years (p > 0.05) andgender, 76% male (p > 0.05).Table 3 summarizes the IHD risk factors of the entire co-hort before and after participation in the standard 16-week CRP, which preceded enrollment into this study. Allparameters improved significantly, except for HDL-C andthe proportion of smokers.Of the 302 participants randomized, 151 were assigned tothe ELMI group and 151 were assigned to the UC group.Table 2: Results of recruitment from January, 1998 to May, 2000.CRP Site 1 CRP Site 2Patients screened 751 295Eligible 356 (47%) 266 (90%)Refused consent 145 (19%) 175 (59%)Randomized 211 (28%) 91 (31%)Table 3: Changes to IHD risk factors from entire cohort as a result of CRP participation (n = 302).Before CRP After CRPTotal cholesterol (mmol/L) 4.71 ± 0.95 4.52 ± 0.87**LDL-C (mmol/L) 2.75 ± 0.80 2.59 ± 0.72**HDL-C (mmol/L) 1.13 ± 0.32 1.14 ± 0.30Triglycerides (mmol/L) 1.83 ± 0.98 1.71 ± 0.89*TC/HDL-C 4.40 ± 1.25 4.15 ± 1.12**Blood Pressure (mmHg) 131/76 ± 22/11 127/72 ± 21/10**Smokers (%) 16 (5%) 12 (4%)Exercise Capacity (METs) 8.4 ± 2.6 10.0 ± 2.5**BMI (kg/m2) 28.0 ± 4.0 27.6 ± 4.0*** p < 0.01 compared to Before CRP (paired samples t-test). ** p < 0.001 compared to Before CRP (paired samples t-test).Page 9 of 14(page number not for citation purposes)and randomized. Table 2 outlines the results of recruit-ment from both CRP sites. Approximately 60% of thoseTables 4 through 6 describe the baseline characteristics ofthe two groups. The proportion of men and women wasCurrent Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9equal between the two groups, as were the sites of recruit-ment, proportion of participants with diabetes and thosewith previous myocardial infarction (MI). Participantsrandomized to the ELMI group had more percutaneoustransluminal coronary angioplasty (PTCA) procedures,less coronary artery bypass graft (CABG) procedures andless frequency of IHD family history than those in the UCgroup. Age was similar between the two groups. Globalrisk scores and all metabolic IHD risk factors were similarbetween the ELMI and UC groups. Other IHD risk factorsand lifestyle parameters were also similar between the twogroups, except for BMI and WC, which were significantlylower in the UC group (Table 6). Changes in IHD risk fac-tors as a result of previous CRP participation were no dif-ferent between the two groups (data not shown).DiscussionThe ELMI trial is designed to test a new method of healthservices delivery that can be readily used in and adaptedto clinical settings throughout North America. To accom-plish this, the ELMI incorporates a number of techniquesproven successful in previous studies (case management,face-to-face visits, telephone follow-ups and incorpora-tion of proven behavioural strategies)[3,6], in addition tothe Lifestyle and Risk Factor Report, the Treatment Algo-rithms and close communications with the ELMI partici-pants' family physicians.Most of the contact between the case manager and theELMI participants will be via telephone. This will allow fora greater frequency of contacts than would be reasonablefor face-to-face visits, thereby permitting more patients tobe managed by one case manager at any given time. Wemum of 15 hours and a maximum of 23 hours of directintervention contact over four years.The incorporation of the Lifestyle and Risk Factor Reportwill: 1) educate and empower the patient and 2) commu-nicate patients' progress to their primary care physicians.Previous literature has revealed that educating and em-powering patients can lead to increased self-efficacy,which in turn can lead to successful behaviourchange.[32,33] Delivering this report to the participant'sprimary care physician will not only facilitate communi-cation (sometimes overlooked between specialist pro-grams and primary care) but has been demonstrated toassist in the treatment of patients.[34]A unique aspect of the ELMI trial involves the design andincorporation of the Treatment Algorithms. These willprovide a consistent management guide across the ELMI,while recognizing that each individual has a unique at-tributable risk, thereby allowing appropriate allocation ofresources. Another important aspect of the study relates tothe use of current published clinical treatment guidelines(the same guidelines that are used in usual care) and the'hands-off' approach to medication changes. These repre-sent departures from previous multi-factorial IHD inter-ventions, in that those studies used treatment targets thatwere more aggressive than usual care at the time and pre-scribed medications directly.[3,35] This method main-tains optimal patient care by providing the primary carephysician with the support and experience of the cardiol-ogist, thus helping to reduce the treatment gap.[20,36]Given that both of the CRPs from which participants wereTable 4: Participant demographics: comparisons between ELMI and UC groups (totals with percentages).ELMI (n = 151) UC (n = 151)Men 125 (83%) 124 (82%)Age (years) 64.8 ± 8.8 63.4 ± 10.2St. Paul's Hospital CRP 108 (72%) 103 (68%)Family History 43 (28%) 58 (38%)*IHD presentationMI 83 (55%) 77 (51%)CABG 46 (30%) 62 (41%)*PTCA 66 (44%) 47 (31%)*Other IHD indicators 24 (16%) 28 (19%)Angina 43 (28%) 35 (23%)Diabetes 26 (17%) 34 (23%)Post-menopausal 14 (54%) 17 (63%)* p < 0.05 compared to ELMI group (independent samples t-test).Page 10 of 14(page number not for citation purposes)estimate that each ELMI participant will receive a mini- recruited draw their populations locally, it is possible thatsome family physicians may have patients in the ELMICurrent Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9group as well as in the UC group at any given time. Whilethese family physicians will receive comprehensive up-dates on their patients in the ELMI group in addition topossible recommendations from the study cardiologist,we do not foresee contamination to those patients of theparticipants' family physicians are meant to inform physi-cians about the nature of the study. Those algorithms thatmay require physician intervention are based on currentguidelines that each physician has likely received on pre-vious occasions from various other sources (British Co-Table 5: Medication use at baseline and year one for the ELMI and UC groups expressed as percent values (with absolute numbers).Medication ELMI (n = 151) UC (n = 151)Lipid lowering 87% (131) 80% (121)β-Blocker 70% (105) 67% (101)ACE Inhibitor 43% (65) 41% (63)Calcium Channel Blocker 26% (39) 22% (33)Diuretic 19% (28) 15% (23)ASA 89% (135) 84% (127)Hypoglycemic Agents 13% (19) 17% (25)Angiotensin Receptor Blocker 5% (7) 3% (5)Anti-anginal 19% (29) 13% (20)Hormone Replacement Therapy (% women)19% (5) 26% (7)Table 6: Baseline comparison of IHD global risk scores between ELMI and UC groups.ELMI (n = 151) UC (n = 151)FRA Risk Score 6.6 ± 3.1 6.5 ± 3.2PROCAM Risk Score (% incidence) 20.0 ± 19.7 17.8 ± 18.5Total cholesterol (mmol/L) 4.46 ± 0.87 4.59 ± 0.93LDL-C (mmol/L) 2.53 ± 0.74 2.69 ± 0.74HDL-C (mmol/L) 1.13 ± 0.31 1.15 ± 0.28Triglycerides (mmol/L) 1.75 ± 0.94 1.65 ± 0.83TC/HDL-C 4.15 ± 1.08 4.16 ± 1.17Glucose (mmol/L) 5.8 ± 1.4 5.8 ± 1.7Blood Pressure (mmHg) 128/72 ± 21/11 127/72 ± 20/10Smokers (%) 5 (3%) 7 (5%)Exercise Capacity (METs) 9.8 ± 2.7 10.0 ± 2.5LTPA (kcal/week) 3137 ± 2531 2963 ± 2183BMI (kg/m2) 28.1 ± 4.2 27.0 ± 3.7*Waist circumference (cm) 95.5 ± 12.8 92.7 ± 11.0*Diet (% daily kcal)Protein 19 ± 4 19 ± 4Carbohydrate 56 ± 9 57 ± 8Fat 22 ± 7 22 ± 7Quality of lifePerceived stress 33 ± 7 32 ± 8Illness intrusive 31 ± 14 31 ± 15Global Self-efficacy 42 ± 4 42 ± 5Exercise self-efficacy 66 ± 11 65 ± 13* p < 0.05 compared to ELMI group (independent samples t-test).Page 11 of 14(page number not for citation purposes)same physician in the UC group to be a major concern.The Treatment Algorithms distributed to the ELMI grouplumbia Medical Association, pharmaceutical marketingand medical journals). Recommendations from the pro-Current Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9gram cardiologist are sent to the physicians regarding ac-tion for their patients in the ELMI group. These will bespecific to each patient's current condition and medica-tions and will not be applicable to other patients. To as-sess the possibility of treatment group crosscontamination within a physician's practice post-studysubgroup analysis will investigate whether the outcomesof those participants in the UC group whose family physi-cians also have patients in the ELMI group differ from theremainder of the UC group participants.The study inclusion criteria were designed to recruit a co-hort representative of current CRP populations. The maininclusion criterion for this study was documented diagno-sis of IHD. Based on the high percentage of participantsrecruited (29% of the entire population and 48% of the el-igible population), this cohort is representative of a largeportion of the CRP population. Compared to other co-horts, our population has similar characteristics to that re-ported in a survey of CRP participants with respect to age,proportion of previous MI, CABG, and diabetes.[37]Women were not over sampled in this study and thereforerepresent only 17.5% of the randomized study popula-tion. It has been well documented that women are under-represented in CRP [38]; even when they do attend CRPs,they are more likely to drop out than men.[39] This mayaccount for the low representation of women in the study.This also places limits on performing subgroup analysisbased on gender.Since the design of this study, two reports investigating in-terventions following CRP have been published .[40,41]In the first study, 40 patients were randomized to a one-year intervention consisting of either monthly counsellingsessions by a nurse or usual care. At the end of the study,participants in the intervention group had significantlylower TC and LDL-C values compared to the usual caregroup.[40] This coincided with a significantly greater pro-portion of intervention participants using lipid-loweringmedications (84% vs. 50%, p < 0.05). The authors con-cluded that the intervention resulted in greater medica-tion compliance and lower lipid values.The second study investigated 31 patients exiting a CRPwho were randomly assigned to either a home-basedmaintenance program or to usual care. Patients were fol-lowed for nine months.[41] The home-based mainte-nance program consisted of an initial visit to theparticipant's home, followed by telephone calls from anexercise physiologist. The calls were conducted every twoweeks during the course of the study. At the end of thestudy, there were no significant differences observed be-tween the two groups with respect to weight, serum lipidshave accounted for the lack of significant results. Despitethe recent report of these two studies, their inconsistencyof results, small sample sizes and limited application tothe multi-factorial nature of IHD make the implementa-tion of the ELMI trial that much more timely.Since this study begins after completion of a CRP, thestudy cohort presents with IHD risk factors and lifestylebehaviours at, or very close to, the recommended targets.Given that the study intervention is not as concentrated asthe initial CRP, it is possible that this could affect the abil-ity to detect a difference between the two groups. Currentliterature, however, indicates that risk factors and lifestylebehaviours decline following completion of a CRP.[7–9,42] Thus, the intervention is designed to maintain thegains from the initial CRP, anticipating that participantsin the UC group will become non-adherent to diet, exer-cise, smoking cessation and medications, resulting in a de-terioration of their risk factor profile.A possible limitation of this study may be the use of glo-bal risk scores as the primary outcome. It is currently ac-cepted that global risk is superior to the measure andinterpretation of any single risk factor.[15] Using a globalrisk score will allow for ease of interpretation of effect, asit is difficult to interpret contradictory changes of individ-ual risk factors (for example, BP decreases while LDL-C in-creases). However, no global risk indicator exists that isapplicable to secondary prevention populations or thatrepresents an outcome of change in global risk. For thisreason, we have chosen to use two independent globalrisk scores to reflect changes in global risk. Although theserisk scores were originally designed to predict future riskof events, this should not pose a problem, as we will assessthe change in these risk scores rather than their predictivevalue.It is generally accepted that a reduction in either of theseglobal risk scores is favourable, regardless of the patientpopulation. Even though other IHD risk factors that aretargeted by the ELMI (obesity, sedentary behaviour anddiet) are not included in the FRA and Procam risk scores,modification of these factors will exert an indirect affecton the risk score. In addition, all risk score componentsand other IHD risk factors will be analyzed as secondaryoutcomes. The collection of cardiovascular events will al-low for possible validation of these two global risk scoresin a secondary population.ConclusionsThe ELMI trial will investigate an individualized multi-fac-torial intervention aimed at preventing the deteriorationin lifestyle behaviours and risk factors that occurs follow-Page 12 of 14(page number not for citation purposes)or exercise capacity. The authors speculated that the lackof deterioration of risk factors in the usual care group maying a CRP. Recruitment and randomization have resultedin a cohort of men and women who are representative ofCurrent Controlled Trials in Cardiovascular Medicine 2002, 3 http://cvm.controlled-trials.com/content/3/1/9those patients completing a typical CRP. With a cohort ofover 300 men and women and a duration of four years,completion of the ELMI trial will make it one of the largestrandomized, multi-factorial lifestyle and risk factor inter-vention studies conducted thus far. To date, no otherstudy has tested an intervention aimed at preventing thelifestyle adherence and risk factor deterioration that fol-low cardiac rehabilitation. If the null hypothesis of theELMI trial is disproved, this will have far-reaching impli-cations for current CRP practices. Conversely, if the nullhypothesis is accepted, this will provide valuable informa-tion with respect to the long-term durability of CRP.Competing interestsNone declaredAuthor contributionsAuthor SAL contributed to the study's design and is re-sponsible for the implementation and analysis of thestudy.Author AI contributed to the design of the medical man-agement protocols and provides input into the medicalmanagement of the participants.Author WL contributed to the design of the behaviouralaspects of the intervention.Author AB aided in recruitment of participants and imple-mentation of the exercise management of the interven-tion.Author MK supervised and interpreted the exercise stresstests (blinded to group assignment).Author JJS contributed to the statistical analyses of thestudy and sample size determination.Author PHP contributed to the design of the study.Author JJF supervised the study's design and provides in-put into the medical management of the participants.All authors read and approved the manuscript.AcknowledgementsThis work was supported by the British Columbia Health Research Foun-dation. 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